CLINICAL TRIAL

Effect of intermittent fasting 16:8 and 14:10

compared with control-group on weight
reduction and metabolic outcomes in obesity
with type 2 diabetes patients: A randomized
controlled trial
Naparat Sukkriang1 , Supawan Buranapin2*
1
School of Medicine, Walailak University, Nakhon Si Thammarat, Thailand, and 2Division of Endocrinology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai
University, Chiang Mai, Thailand

Keywords ABSTRACT
Intermittent fasting, Weight reduction, Aims/Introduction: To compare the percent weight change and metabolic outcomes
Metabolic outcomes among diabetic participants with obesity on intermittent fasting (IF) 16:8, IF 14:10, or
normal controlled diets.
*Correspondence Materials and Methods: A randomized controlled trial was conducted to randomize
Supawan Buranapin participants into three groups. Each group followed IF 16:8, IF 14:10, according to the
Tel: 66-867310392 protocol 3 days/week for 3 months or a control group.
E-mail address:
Results: A total of 99 participants completed the study. The percentage weight
[email protected]
change from baseline was -4.02% (95% CI, -4.40 to -3.64) in IF 16:8, -3.15% (95% CI, -3.41
to -2.89) in IF 14:10, and -0.55% (95% CI, -1.05 to -0.05) in the control group. The
J Diabetes Investig 2024; 15: 1297– percentage weight loss from baseline was significantly more in both IF groups (P < 0.001,
1305 both) when compared with the control group. Weight loss was significantly more in the IF
16:8 group than in that of the IF 14:10 group (P < 0.001). Metabolic outcomes (decrease in
doi: 10.1111/jdi.14186 FBS and HbA1C, and improvement in lipid profiles) were significantly improved from
baseline in both IF groups in comparison with the control group.
Conclusions: Either IF 16:8 or 14:10 had a benefit in the percentage weight change,
glucose and lipid profiles in obese diabetic patients compared with the control group
when consumed for 3 days a week for 3 months.

INTRODUCTION through diet control and exercise, anti-obesity drugs, and bar-
Energy intake that is more than energy output can cause obe- iatric surgery. The choice of treatment depends on underlying
sity. Obesity affects the development of a range of comorbid- disease, severity of obesity, contraindications, and the indica-
ities, including type 2 diabetes mellitus, hypertension, tions of each treatment options3. Intermittent fasting (IF) has
dyslipidemia, cardiovascular disease, certain types of cancer, been used popularly in diet control for weight loss. It consists
and an increased mortality rate1. The definition of obesity in of regular alternating periods of unrestricted dietary consump-
Thailand uses the Regional Office for the Western Pacific tion and abstinence from caloric intake. Intermittent fasting has
(WPRO) criteria which classifies overweight as a body mass the benefit of decreasing weight, controlling blood pressure,
index (BMI) of 23.0–24.9 kg/m2, Class I obesity as a BMI of and reducing the risk of metabolic syndrome4–7.
25.0–29.9 kg/m2, and Class II obesity as a BMI of ≥ 30.0 kg/ There are several popular types of intermittent fasting, such as
m22. The treatment of obesity consists of lifestyle modification time-restricted eating (TRE), complete alternate day fasting, and
religious fasting8. In TRE, the daily caloric intake is limited to a
consistent window of about 8–10 h9. 16:8 is a fasting period of
Received 20 November 2023; revised 8 February 2024; accepted 4 March 2024

ª 2024 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd J Diabetes Investig Vol. 15 No. 9 September 2024 1297
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution
in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
CLINICAL TRIAL
Sukkriang and Buranapin http://wileyonlinelibrary.com/journal/jdi

16 h and an eating period of 8 h and 14:10 is a fasting period of group fasted for 14 h 3 days per week, 2 days on a weekday, and
14 h and an eating period of 10 h. Peeke et al. studied TRE 14:10, 1 day on a weekend for 3 months, because it is easy to adhere to
a subtype of IF for at least 5 days a week for 2 months in the protocol. The participants could drink water during the fast-
non-diabetic participants with a BMI of ≥ 30.0 kg/m2 and found ing period. For the control group, the participants ate consistently
that TRE 14:10 helped them to lose 8.5% of the baseline body three meals on diabetic diets. All participants were advised to fol-
weight (P < 0.001) and significantly decreased blood glucose by low a general diabetic diet (such as avoiding desserts, sticky rice,
7.6 mg/dL from the baseline (P < 0.05)10. On the contrary, the and high-sugar diets) advised by a nutritionist and were sug-
study of Lowe et al. in non-diabetes with a BMI of ≥ 27 kg/m2 gested to exercise at least 3 days per week. The follow-up required
using TRE 16:8 resulted in a decrease of body weight (BW) when three face-to-face visits at 0, 6, and 12 weeks, and one phone visit
compared with the baseline (-0.94 kg; P = 0.01), but was not sta- at 2 weeks. Twenty-four-hour food records for 3 and 7 days phys-
tistically significant when compared with consistent meal ical activity records were requested from all groups before each
timing11. Nowadays, there is a gap in knowledge about the differ- visit. At the first visit, the participants were interviewed face-to--
ence in weight loss and metabolic outcomes in types of IF. The face and demographic data including age, underlying diseases,
previous study showed that 10 h restricted feeding improved duration of diabetes, current medications, history of complica-
blood glucose and decreased the BW when compared with the tions of diabetes such as diabetic retinopathy and nephropathy,
control12. However, there are no previous data comparing two IF history of steroid use or hormonal drug use, history of hypoglyce-
groups and a control group for weight loss and metabolic out- mia, or history of admission were reviewed from medical records.
comes. Therefore, the purpose of this study was to investigate the Anthropometric measurements such as BW, height, weight cir-
effect of IF 14:10 and IF 16:8 on weight reduction and metabolic cumference (WC), and hip circumference (HC) were measured
outcomes in obese diabetic patients when compared with control at 0, 6, and 12 weeks. The participants were interviewed about
or a normal diet. We would like to compare two IF groups to see fasting time and eating time, food intake, and hypoglycemic
whether there is any difference in outcomes between fasting for symptoms by phone visit at 2 weeks, and face-to-face at 6 and
16 and 14 h. If fasting for 14 h has the same benefit as fasting for 12 weeks. Fasting blood sugar and lipid profiles were measured at
16 h, we might suggest that our diabetic subjects fast only 14 h as 0 and 12 weeks. The adherence to the fasting time was evaluated
it is easier to follow. The primary outcome was weight loss. The from the interview of food intake and food records before each
secondary outcomes were changes in fasting blood glucose (FBS), visit. A discontinuation of intervention was evaluated at visits 2,
HbA1C, and lipid profiles. 6, and 12 weeks and was defined as fasting for less than 3 days/
week. The hunger score was measured at 6 and 12 weeks. All
MATERIALS AND METHODS adverse effects were measured at 2, 6, and 12 weeks. The partici-
Study design, setting pants were interviewed regarding hypoglycemic symptoms at all
This 12 week RCT was carried out in the Outpatient Clinic at the visits.
Faculty of Medicine, Chiang Mai University Hospital, Chiang
Mai, Thailand from 23 November 2021 to 30 September 2022. Participants
This study was conducted following the Declaration of Helsinki The inclusion criteria included all of the following:
and was approved by the Research Ethics Committee on Human BMI ≥ 25 kg/m2, age 30–60 years old, and type 2 diabetes melli-
Rights Related to Research Involving Human Subjects, Chiang tus diagnosed using American Diabetes Association criteria13.
Mai University, Thailand (MED-2564-08471). Overall, 108 obese The exclusion criteria included a history of steroids, hormonal
participants with type 2 diabetes mellitus, of both sexes, aged 30– drugs, or weight loss medications used within 3 months, preg-
60 years voluntarily participated in this research after giving nancy or planning to become pregnant, history of cancer, HIV,
informed consent at a screening visit and were enrolled in the active pulmonary tuberculosis, hepatitis B or C infection,
study. The subjects were randomized into three groups, IF 16:8, admission to hospital within 3 months, previous IF in
IF 14:10, or the control group by using 6-block randomization. 3 months, previous history of severe hypoglycemia within
Neither the investigators nor the participants were blinded to the 6 months, being bed-ridden, a history of a swallowing problem,
intervention. However, the analysis process was blinded to the GI surgery e.g. bariatric surgery, using insulin injections in the
intervention group. Hypoglycemic agents and lipid-lowering current treatment, glipizide dose >15 mg/day, gliclazide modi-
drugs had to be used in a stable dose during the study except fied release >60 mg/day, taking another sulfonylurea except for
when the participants had hypoglycemia (capillary blood glipizide and gliclazide modified release, taking a stable dose of
glucose < 70 mg/dL). On a fasting day, if the participants were SGLT2/GLP1-RA for less than 1 month, chronic kidney disease
taking hypoglycemic agents at a once daily dose, the hypoglyce- stage IIIB-V, acute myocardial infarction or stroke within the
mic agents were taken at the first meal. If taking twice a day, the past 6 months.
hypoglycemic agents were taken at the first and last meals. If tak-
ing three times a day, the hypoglycemic agents were taken at the Anthropometric measurements
first meal, in the middle period of fasting, and at the last meal. Body weight and height were measured with participants wear-
The IF 16:8 group was instructed to fast for 16 h and the IF 14:10 ing light clothing in a standing position and barefoot with an

1298 J Diabetes Investig Vol. 15 No. 9 September 2024 ª 2024 The Authors. Journal of Diabetes Investigation published by AASD and John Wiley & Sons Australia, Ltd
 CLINICAL TRIAL
http://wileyonlinelibrary.com/journal/jdi Effect of IF in obese diabetic patients

electronic digital scale Tanita RD-953 and a stadiometer. Body follow-up rate, it finally summed with 36 subjects per group, or
weight was recorded to the nearest 0.05 kg and height was a total 108 subjects. Statistical analysis was performed using
recorded to the nearest 0.5 cm. BMI was calculated by BW (kg) SPSS version 22 and STATA program version 17. Quantitative
divided by height squared (m2). variables were described as mean – SD for normally distributed
data. Categorical variables were expressed as percentages and
Total calorie intakes and physical activity frequencies. One-way ANOVA was used for continuous vari-
The total calorie intake was interpreted from the mean of food ables. The chi-square or Fisher’s exact test was used for cate-
records 3 days before each visit. The food records included the gorical variables as appropriate. Changes from baseline were
amount, meal, timing of eating, and name of foods. The food the differences between pre-intervention and post-intervention
records were reviewed by phone at 2 weeks and face-to-face at analyzed by using a repeated measured mixed model controlled
visits 6 and 12 weeks. The NutriFact Program, which was devel- by baseline data. The percent BW loss was analyzed by using
oped by Research Institute for Health Sciences, Chiang Mai Firth’s logistic regression without covariates. The data signifi-
University, was used for interpreting food intakes. It can inter- cant were considered when the P-value was < 0.05.
pret the amount and name of food intake to kilocalorie intake
by using data from previous research on kilocalories of foods RESULTS
and the nutrient labels on foods in Thailand14,15. The mean of In total 109 participants met the eligibility criteria and 108 were
3 days of food records (kcal/day) at 2, 6, and 12 weeks was cal- enrolled in the study. However, 9 of those were discontinued
culated. The kilocalories of physical activity (kcal/day) were cal- from the study, 33 participants in IF 16:8 and 33 participants in
culated from weekly physical activity records and regular IF 14:10, who fasted on 3 days/week for 3 months and 33 partic-
activities before each visit by using the metabolic equivalent ipants in the control group. Overall discontinuation of interven-
score (MET), duration of activity, age, and BW16,17. tion and loss to follow-up was 8.33% as shown in Figure 1.

The total physical activity ðkcal=dayÞ ¼ Characteristics of the participants at baseline

½activity  specific MET ðkcal=kg=hÞ  BWðkgÞ As shown in Table 1, 99 participants had a mean age of
duration of activity ðminute=60Þ 45.29 – 6.08 years, mean weight of 82.32 – 15.37 kg, mean BMI
of 31.91 – 5.16 kg/m2, mean type 2 diabetes mellitus duration of
frequency=week ðtimes=weekÞ=7
5.42 – 4.46 years, mean FBS of 149.32 – 36.92 mg/dL, mean
HbA1C of 7.75 – 0.83%. Most participants were female. There
Laboratory measurement were no significant differences in baseline characteristics among
After fasting for 8–12 h, venous blood was collected in the the three groups.
morning for measuring FBS, HbA1C, and lipid profiles at 0
and 12 weeks. Average total calorie intakes and physical activity
The average total calorie intakes were lowest in all groups at
2 weeks, then the subjects gradually increased their calorie
Hunger score and adverse effects intake at 6 weeks and at the highest calorie intake at 12 weeks.
The hunger score was a subjective rating and was taken from a The total calorie intakes in the two IF groups were significantly
visual analog scale, numeric range from 0 to 10, where 0 was lower than the control group at 6 weeks, but not at 12 weeks
the lowest hunger and 10 was the maximum hunger18,19. It was (Figure 2a). There was no significant difference in physical
measured by interviewing the participants face-to-face at 6 and activities among the three groups at any time. The participants
12 weeks and recorded to the nearest 0.5. The hunger score in all three groups increased their physical activity in the first
was used to evaluate the hunger degree in the morning. The 6 weeks as advised, however, it decreased thereafter (Figure 2b).
hypoglycemic symptoms were reviewed at all visits. The symp-
toms of adverse effects were screened with open questions, as BW change from baseline
well as the frequency of adverse effects such as palpitations, diz- The percentage of weight change at 6 and 12 weeks in the control
ziness, headache, abdominal pain, mood change, vomiting, and group was not significantly different from the baseline. Both the
hypoglycemia. IF groups had a significant weight loss at 6 and 12 weeks
from baseline. The percentage of weight change from baseline
Statistical analysis was -4.02% (95% CI, -4.40 to -3.64) in IF 16:8, -3.15% (95% CI,
The sample size (N ) was calculated by the estimated sample -3.41 to -2.89) in IF 14:10, and -0.55% (95% CI, -1.05 to -0.05)
size for two-sample comparison with repeated measures. A in the control group at 12 weeks. The percentage of weight loss
one-sided, alpha-error 0.05, a statistical power 80%, ratio = 1:1, was significantly more in both IF groups than in the control
with a mean difference of 2.0 kg and standard deviation of group and was significantly more in IF 16:8 than IF 14:10 at 6
4.5 kg was used from the Peeke et al. study10. The study size and 12 weeks (Figure 3a). The mean BW change from baseline
was 32 subjects per group. With an allowance of a 10% loss to was -3.18 kg (95% CI, -3.41 to -2.96 kg) in IF 16:8, -2.5 kg (95%

ª 2024 The Authors. Journal of Diabetes Investigation published by AASD and John Wiley & Sons Australia, Ltd J Diabetes Investig Vol. 15 No. 9 September 2024 1299
CLINICAL TRIAL
Sukkriang and Buranapin http://wileyonlinelibrary.com/journal/jdi

Figure 1 | Study flow.

Table 1 | Characteristics of the participants at baseline

Characteristics IF 16:8 n = 33 IF 14:10 n = 33 Control n = 33 P-value

Age (years) 46.43 – 5.89 45.13 – 6.65 44.32 – 5.65 0.366

Female sex, n (%) 20 (60.60) 20 (60.60) 18 (54.55) 0.847
BW (kg) 82.31 – 16.06 81.83 – 15.50 82.82 – 15.36 0.967
Height (m) 1.60 – 0.09 1.61 – 0.07 1.60 – 0.08 0.814
BMI (kg/m2) 31.87 – 4.89 31.45 – 5.26 32.42 – 5.42 0.749
WC (cm) 103.84 – 11.10 104.12 – 11.01 106.52 – 10.38 0.547
HC (cm) 104.81 – 9.42 106.51 – 11.54 108.11 – 10.14 0.438
Duration of DM (years) 5.09 – 4.79 5.52 – 4.03 5.63 – 4.63 0.878
Diabetic retinopathy, n (%) 3 (9.09) 5 (15.15) 5 (15.15) 0.702
Urine microalbumin to creatinine ratio, n (%)
<30 22 (66.67) 23 (69.70) 23 (69.70) 0.954
30–300 11 (33.33) 9 (27.27) 9 (27.27) 0.823
>300 0 (0.00) 1 (3.03) 1 (3.03) 1.000
No DM medication 1 (3.03) 3 (9.09) 2 (6.06) 0.869
Metformin, n (%) 32 (96.96) 30 (90.91) 30 (90.91) 0.693
Sulfonylurea, n (%) 11 (33.33) 14 (42.42) 13 (39.39) 0.742
Thiazolidinedione, n (%) 13 (39.39) 10 (30.30) 10 (30.30) 0.664
SGLT2 inhibitors*, n (%) 7 (21.21) 5 (15.15) 7 (21.21) 0.771
DPP4 inhibitors, n (%) 7 (21.21) 5 (15.15) 5 (15.15) 0.753
Dyslipidemia, n (%) 23 (69.7) 25 (75.76) 22 (66.67) 0.711
Hypertension, n (%) 23 (69.7) 22 (66.67) 27 (81.82) 0.343
SBP (mmHg) 135.03 – 9.42 132.82 – 9.48 135.82 – 9.64 0.417
DBP (mmHg) 84.24 – 7.99 83.21 – 9.27 82.76 – 9.06 0.782
FBS (mg/dL) 152.79 – 35.49 154.79 – 36.03 140.39 – 38.62 0.231
HbA1C (%) 7.91 – 0.94 7.85 – 0.78 7.49 – 0.72 0.082
Cholesterol (mg/dL) 185.21 – 36.64 171.03 – 33.68 168.78 – 30.70 0.106
TG (mg/dL) 149.54 – 51.66 154.65 – 53.67 170.63 – 62.76 0.287
HDL (mg/dL) 46.42 – 9.24 48.21 – 9.84 44.61 – 11.12 0.353
LDL (mg/dL) 114.42 – 33.02 106.06 – 27.75 98.76 – 23.22 0.143

Statistically significant at P-value < 0.05. BMI, body mass index; BW, body weight; DBP, diastolic blood pressure; DM, diabetes mellitus; FBS, fasting
blood sugar; HbA1C, hemoglobin A1C; HC, hip circumference; HDL, high density lipoprotein; LDL, low density lipoprotein; SBP, systolic blood pres-
sure; TG, triglyceride; WC, waist circumference. *Start taking SGLT2 inhibitor >1 month and stable dose in 1 month when enrolled to the study.

CI, -2.65 to -2.35 kg) in IF 14:10 and -0.4 kg (95% CI, -0.78 to FBS and HbA1C change from baseline
-0.03 kg) in the control group. The percent achieving weight loss The mean change in FBS from baseline was -30.91 mg/dL
≥5% was highest in IF 16:8. However, only 15.2% of the partici- (95% CI, -39.90 to -21.91 mg/dL) in IF 16:8, -28.06 mg/dL
pants in IF 16:8 had achieved 5% weight loss (Figure 3b). (95% CI, -38.83 to -17.29 mg/dL) in IF 14:10, -9.09 mg/dL

1300 J Diabetes Investig Vol. 15 No. 9 September 2024 ª 2024 The Authors. Journal of Diabetes Investigation published by AASD and John Wiley & Sons Australia, Ltd
 CLINICAL TRIAL
http://wileyonlinelibrary.com/journal/jdi Effect of IF in obese diabetic patients

Figure 2 | (a) Average total calories intake (kcal/day), (b) Physical activity (kcal/day).

Figure 3 | (a) Percent change of BW from baseline, (b) Percent BW loss.

(95% CI, -16.44 to -1.74 mg/dL) in the control group (Figure with no significant difference between the two IF groups
4a). The mean HbA1C change from baseline was -0.499% (Figure 5b,c). The mean HDL was significantly increased from
(95% CI, -0.649 to -0.350%) in IF 16:8, -0.528% (95% CI, baseline in all three groups and increased more in the two IF
-0.715 to -0.340%) in IF 14:10, -0.197% (95% CI, -0.371 to groups than in the control group, with no significant difference
-0.023%) in the control group (Figure 4b). The means of between the two IF groups (P = 0.434; Figure 5d).
FBS and HbA1C were significantly decreased from baseline in
all three groups. However, FBS and HbA1c were significantly Hunger score and adverse effects
decreased more in both IF groups than the control group, The mean hunger score in the two IF groups was significantly
without a significant difference between the two IF groups. higher than the control group at 6 and 12 weeks. However, the
hunger scores were only moderate (score 4–5 in the two IF
Lipid change from baseline groups and 2 in the control group), not too severe until the par-
The mean triglyceride (TG) was significantly decreased from ticipants had to deviate from the protocol. There was no signifi-
baseline in all three groups. However, triglyceride significantly cant difference in the mean hunger score between the two IF
decreased more in the IF groups than in the control group, groups (Table S1). The most common adverse effect was palpita-
with no significant difference between the two IF groups tions, followed by dizziness, abdominal pain, and mood change
(P = 0.490; Figure 5a). The total cholesterol and LDL decreased which were not significantly different between three groups. All
significantly from baseline in only in the two IF groups and three groups had no documented hypoglycemia and had no
decreased more in the two IF groups than the control group, change in diabetic drug doses during the intervention (Table S2).

ª 2024 The Authors. Journal of Diabetes Investigation published by AASD and John Wiley & Sons Australia, Ltd J Diabetes Investig Vol. 15 No. 9 September 2024 1301
CLINICAL TRIAL
Sukkriang and Buranapin http://wileyonlinelibrary.com/journal/jdi

Figure 4 | (a) Change in FBS from baseline, (b) Change in HbA1C from baseline.

Figure 5 | (a) Change in triglyceride from baseline, (b) Change in total cholesterol from baseline, (c) Change in LDL from baseline, (d) Change in
HDL from baseline.

DISCUSSION weight, a decrease in FBS and HbA1c, as well as an improve-

This study demonstrated that obese patients with type 2 diabe- ment in lipid profiles from baseline without a significant differ-
tes mellitus who followed either IF16:8 or 14:10 consuming ence between the two intermittent fasting groups, except for
3 days a week for 3 months duration had a significant loss of weight loss which was significantly more in the IF 16:8 group,

1302 J Diabetes Investig Vol. 15 No. 9 September 2024 ª 2024 The Authors. Journal of Diabetes Investigation published by AASD and John Wiley & Sons Australia, Ltd
 CLINICAL TRIAL
http://wileyonlinelibrary.com/journal/jdi Effect of IF in obese diabetic patients

and significantly more than in the control group. Che et al., in in LDL and triglyceride level might decrease the cardiovascular
a study in China, compared IF 14:10 (eating time from 8:00– risk in obese patients21.
18:00) every day with the control in type 2 diabetes mellitus In mouse studies, intermittent fasting during the dark cycle
obese patients for 12 weeks, and demonstrated that the mean improved glucose tolerance, increased ghrelin, and reduced
change in BW from baseline was -2.98 kg in the 14:10 group, leptin9,28,29. However, in a human study, the ghrelin and leptin
-0.83 kg in the control group (P < 0.001), FBS was -26 mg/dL remained unchanged with early intermittent fasting, despite a
from baseline in the 14:10 group, -14 mg/dL in the control subjective appetite improvement9,30. In this study, subjects in
group (P < 0.001), HbA1C was -1.54% in the 14:10 group and both IF groups reported more hunger than subjects in the control
-0.66% in the control (P < 0.001)12. The results were in the group which is the same as the study of Sundfør et al.26. A higher
same trend as our study. The degree of weight loss was compa- hunger score increases food craving26 and can increase the rate of
rable to our study, however, the glycemic control was more in non-adherence to the protocol and causes weight to be regained
Che et al. study than in our study. The difference between the particularly in the longer-term study. Paoli et al. showed that eat-
two studies was the frequency of IF 14:10 which was practiced ing breakfast, avoiding late-night meals, and fasting from 12 to
every day in the Che et al. study but only 3 days/week in our 16 h improved insulin sensitivity and decreased total cholesterol
study. The age of the participants had a wider range than our and hunger31. Therefore, intermittent fasting late-night and eat-
study (18–70 years) and a different nationality of the subjects. ing during the day should improve metabolic parameters than
Yaun et al. did a systemic review and meta-analysis of ten fasting in the morning. Moro et al. reported that IF 16:8 for
RCTs and supported that the IF helped to achieve BW loss 8 weeks maintained muscle mass in 34 resistance-trained males
and improvement in FBS by decreasing insulin resistance in when compared with the normal diet group32, but our study did
obese patients7. Furthermore, the animal model showed that IF not record the data of muscle function. The strength of the study
improved metabolism by acting through the molecular circa- is that it is the first RCT to study varying hours of fasting time
dian clock and gut microbiome composition9. and fasting only 3 days a week for 3 months in IF groups and
The improvement in triglyceride with intermittent fasting in control group on weight loss and metabolic outcomes in obese
our study had the same results as the study of Hutchison et al. diabetic Thais. The weakness of the study is that it was a
which assessed the effects of 9 h IF in prediabetic men in single-center study. The adherence to the fasting time was
Australia20. Gabel et al. found that intermittent fasting helped not checked from the interview of food intake and 3 day food record
only in decreasing in triglyceride and fat mass but also in decreas- only 3 days before each visit at 2, 6, and 12 weeks. The subjects
ing oxidative stress21. The significant decrease in mean choles- might not eat in the same pattern every day. The limitation is the
terol and LDL from baseline in both IF groups in our study was energy intake from 3 days food record might be not accurate or
the same result as a systematic review and meta-analysis of Liu not represent all the intervention period.
et al. which included 17 RCTs and showing that intermittent fast- In conclusion, both IF 16:8 and 14:10 when consumed 3 days
ing had a beneficial effect in decreasing total cholesterol, and a week for 3 months had benefits in losing weight and improv-
LDL, but no significant benefit in HDL22. Wilkinson et al. investi- ing metabolic parameters in obese, type 2 diabetes mellitus
gated the effect of a 10 h IF in patients with metabolic syndrome Thais compared with the control group without any serious
in the US and demonstrated that the LDL in the IF group adverse effect or hypoglycemia. Intermittent fasting 16:8 had
decreased significantly when compared with baseline LDL more benefit in losing body weight than IF 14:10.
(P = 0.016), but no significant change in HDL (P = 0.051)23. Our
study showed an improvement in HDL in the IF groups which ACKNOWLEDGMENTS
was in contrast to the study of Cienfuegos et al. which compared We would like to thank the Endocrine Society of Thailand for
4 h IF (eating only from 3.00–7.00 pm) and 6 h IF (eating only the funding, Mrs Antika Wongthanee for statistical analysis, Dr
from 1.00 to 7.00 pm) for 10 weeks in obese participants, who Phichayut Phinyo for sample size calculation, Mrs Suthathip
exercised less than 2 h/week and showed no significant increase Wongsritep for interpreting Nutri Facts Program, Ms Ruth
in HDL level when compared with the control group and base- Leatherman for editing the manuscript, nurses, nutritionists,
line HDL24. The systematic review and meta-analysis to compare and all participants for their devotion to the study.
the efficacy of intermittent fasting vs continuous energy restric-
tion (CER) by Xu et al. showed intermittent fasting was more FUNDING INFORMATION
effective than CER in increasing HDL. Sundfør et al. showed IF This research was funded by the Endocrine Society of Thailand,
in participants aged 21–70 years with obesity increased HDL. the grant year 2021, and the article processing charge was
However, no data have explained the mechanism of HDL and IF funded by Chiang Mai University.
until now25,26. In the animal model, IF without caloric restriction
has been shown to prevent dyslipidemia and age-related decline DISCLOSURE
in cardiac function9. IF increased the expression of hepatic lipase There are no conflicts of interest to disclose.
and decreased the expression of the lipid droplet-associated and Approval of the research protocol: This study was approved by
lipolysis inhibitor gene9,27. In addition, the results of improving the Research Ethics Committee on Human Rights Related to

ª 2024 The Authors. Journal of Diabetes Investigation published by AASD and John Wiley & Sons Australia, Ltd J Diabetes Investig Vol. 15 No. 9 September 2024 1303
CLINICAL TRIAL
Sukkriang and Buranapin http://wileyonlinelibrary.com/journal/jdi

Research Involving Human Subjects, Chiang Mai University, 14. Wungrath J, Intawong K, Boonchieng W. CMU Healthy
Thailand (MED-2564-08471), date of approval: 23 Break,The Web-base program for the nutritional value
November, 2021. calculating of thai snack to support healthy consumption.
Informed consent: All participants were informed consent Elem Educ Online 2021; 20: 2155–2165.
before enrolling in the study. 15. Puwastien P. Issues in the development and use of food
Registry and the registration no. of the study/trial: The trial was composition databases. Public Health Nutr 2002; 5(6a): 991–
registered on Thai Clinical Trials (TCTR 20230131002), date of 999.
approval: 31 January, 2023. 16. Eckel SP, Bandeen-Roche K, Chaves PH, et al. Surrogate
Animal studies: There was no animal studies involved. screening models for the low physical activity criterion of
frailty. Aging Clin Exp Res 2011; 23: 209–216.
REFERENCES 17. Sukkriang N, Punsawad C. Comparison of geriatric
1. Kinlen D, Cody D, O’Shea D. Complications of obesity. QJM assessment tools for frailty among community elderly.
2018; 111: 437–443. Heliyon 2020; 6: e04797.
2. World Health Organization. Regional Office for the Western 18. Delgado DA, Lambert BS, Boutris N, et al. Validation of
P. The Asia-Pacific Perspective: Redefining Obesity and its digital visual analog scale pain scoring with a traditional
Treatment. Sydney: Health Communications Australia, 2000. paper-based visual analog scale in adults. J Am Acad Orthop
3. Kheniser K, Saxon DR, Kashyap SR. Long-term weight loss Surg Glob Res Rev 2018; 2: e088.
strategies for obesity. J Clin Endocrinol Metab 2021; 106: 19. Poortvliet PC, Bérubé-Parent S, Drapeau V, et al. Effects of a
1854–1866. healthy meal course on spontaneous energy intake, satiety
4. Vasim I, Majeed CN, DeBoer MD. Intermittent fasting and and palatability. Br J Nutr 2007; 97: 584–590.
metabolic health. Nutrients 2022; 14: 3. 20. Hutchison AT, Regmi P, Manoogian ENC, et al.
5. Collier R. Intermittent fasting: The science of going without. Time-restricted feeding improves glucose tolerance in men
CMAJ 2013; 185: E363–E364. at risk for type 2 diabetes: A randomized crossover trial.
6. Mandal S, Simmons N, Awan S, et al. Intermittent fasting: Obesity (Silver Spring, Md) 2019; 27: 724–732.
Eating by the clock for health and exercise performance. 21. Gabel K, Cienfuegos S, Kalam F, et al. Time-restricted eating
BMJ Open Sport Exerc Med 2022; 8: e001206. to improve cardiovascular health. Curr Atheroscler Rep 2021;
7. Yuan X, Wang J, Yang S, et al. Effect of intermittent fasting 23: 22.
diet on glucose and lipid metabolism and insulin resistance 22. Liu L, Chen W, Wu D, et al. Metabolic efficacy of
in patients with impaired glucose and lipid metabolism: A time-restricted eating in adults: A systematic review and
systematic review and meta-analysis. Int J Endocrinol 2022; meta-analysis of randomized controlled trials. J Clin
2022: 6999907. Endocrinol Metab 2022; 107: 3428–3441.
8. Nowosad K, Sujka M. Effect of various types of 23. Wilkinson MJ, Manoogian ENC, Zadourian A, et al. Ten-hour
intermittent fasting (IF) on weight loss and improvement time-restricted eating reduces weight, blood pressure, and
of diabetic parameters in human. Curr Nutr Rep 2021; 10: atherogenic lipids in patients with metabolic syndrome. Cell
146–154. Metab 2020; 31: 92–104.e5.
9. Manoogian ENC, Chow LS, Taub PR, et al. Time-restricted 24. Cienfuegos S, Gabel K, Kalam F, et al. Effects of 4- and 6-h
eating for the prevention and Management of Metabolic time-restricted feeding on weight and cardiometabolic
Diseases. Endocr Rev 2022; 43: 405–436. health: A randomized controlled trial in adults with obesity.
10. Peeke PM, Greenway FL, Billes SK, et al. Effect of time Cell Metab 2020; 32: 366–378.e3.
restricted eating on body weight and fasting glucose in 25. Xu R, Cao Y, Wang P-Y, et al. Intermittent energy restriction
participants with obesity: Results of a randomized, vs. continuous energy restriction on cardiometabolic risk
controlled, virtual clinical trial. Nutr Diabetes 2021; 11: 6. factors in patients with metabolic syndrome: A
11. Lowe DA, Wu N, Rohdin-Bibby L, et al. Effects of meta-analysis and systematic review. Front Nutr 2023; 10:
time-restricted eating on weight loss and other metabolic 1090792.
parameters in women and men with overweight and 26. Sundfør TM, Svendsen M, Tonstad S. Effect of
obesity: The TREAT randomized clinical trial. JAMA Intern intermittent versus continuous energy restriction on
Med 2020; 180: 1491–1499. weight loss, maintenance and cardiometabolic risk: A
12. Che T, Yan C, Tian D, et al. Time-restricted feeding improves randomized 1-year trial. Nutr Metab Cardiovasc Dis 2018;
blood glucose and insulin sensitivity in overweight patients 28: 698–706.
with type 2 diabetes: A randomised controlled trial. Nutr 27. Puri V, Konda S, Ranjit S, et al. Fat-specific protein 27, a
Metab 2021; 18: 88. novel lipid droplet protein that enhances triglyceride
13. Association AD. 2. Classification and diagnosis of diabetes: storage. J Biol Chem 2007; 282: 34213–34218.
Standards of medical Care in Diabetes—2021. Diabetes Care 28. Sundaram S, Yan L. Time-restricted feeding reduces adiposity
2020; 44(Supplement_1): S15–S33. in mice fed a high-fat diet. Nutr Res 2016; 36: 603–611.

1304 J Diabetes Investig Vol. 15 No. 9 September 2024 ª 2024 The Authors. Journal of Diabetes Investigation published by AASD and John Wiley & Sons Australia, Ltd
 CLINICAL TRIAL
http://wileyonlinelibrary.com/journal/jdi Effect of IF in obese diabetic patients

29. Hatori M, Vollmers C, Zarrinpar A, et al. Time-restricted 31. Paoli A, Tinsley G, Bianco A, et al. The influence of meal
feeding without reducing caloric intake prevents metabolic frequency and timing on health in humans: The role of
diseases in mice fed a high-fat diet. Cell Metab 2012; 15: fasting. Nutrients 2019; 11: 719.
848–860. 32. Moro T, Tinsley G, Bianco A, et al. Effects of eight weeks of
30. Sutton EF, Beyl R, Early KS, et al. Early time-restricted feeding time-restricted feeding (16/8) on basal metabolism, maximal
improves insulin sensitivity, blood pressure, and oxidative strength, body composition, inflammation, and
stress even without weight loss in men with prediabetes. cardiovascular risk factors in resistance-trained males. J
Cell Metab 2018; 27: 1212–1221.e3. Transl Med 2016; 14: 290.

SUPPORTING INFORMATION
Additional supporting information may be found online in the Supporting Information section at the end of the article.

Table S1. Hunger score at 6 and 12 weeks.

Table S2. Adverse effects at 12 weeks.

ª 2024 The Authors. Journal of Diabetes Investigation published by AASD and John Wiley & Sons Australia, Ltd J Diabetes Investig Vol. 15 No. 9 September 2024 1305
Copyright of Journal of Diabetes Investigation is the property of Wiley-Blackwell and its
content may not be copied or emailed to multiple sites or posted to a listserv without the
copyright holder's express written permission. However, users may print, download, or email
articles for individual use.