Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06364475 |
| Other study ID # |
BezmialemVU-TF-AÖ-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
September 1, 2022 |
Study information
| Verified date |
April 2024 |
| Source |
Bezmialem Vakif University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The prevalence of obesity and obesity-related diseases are on the rise worldwide. The widely
accepted approach in dietary treatment of obesity is the calorie-restricted three meals-three
snacks a day diet; however, alternative approaches are needed. This study was conceived with
a view to comparing time-restricted eating, a method which can be easily conveyed and applied
in overcoming obesity, to a six meals a day diet. 174 participants aged between 18-65 with a
BMI>25 kg/m2 were included. Diet lists with similar calorie, macro counts suitable for their
respective group were prepared. Anthropometric measurements, blood pressure, blood tests were
analyzed before the study and at the end of the 8-week.
Description:
Our study was conducted with participants, aged between 18-65 and with a BMI >25 kg/m2, who
consulted a family medicine clinic in Istanbul, accepted the terms and conditions of the
study and signed the volunteer consent form. Sample analysis was performed by T.M. with G
Power 3.1.9.7 (Franz Faul, Germany), using data from Sundfør et al.'s study, "Effect of
intermittent versus continuous energy restriction on weight loss, maintenance and
cardiometabolic risk: a randomized 1-year trial". The effect size was assumed to be d: 0.382
for the purposes of calculation. After the calculation made with the aforementioned effect
size, with 80% power and 10% margin of error, it was concluded that a cohort of at least 126
samples, of which 63 would be in the patient group and 63 would be in the control group,
should be used in this study.
People with a history of bariatric surgery, eating disorders, alcohol and drug addiction,
anti-obesity medication use, diagnosed with diabetes and hypothyroidism, active cancer
patients and people carrying infectious diseases were excluded from the study. At the
beginning of the study, 88 people were included in the 16:8 time-restricted intermittent
fasting (time-restricted eating) group, with an eating plan of 400 kcal lower than the total
daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat
and 25% protein); and 86 people were included in the energy-restricted six-meal group. Diet
lists suitable for each group were prepared, and food substitution lists were handed out to
the participants. Control measurements were performed after the 4th week. In order to keep
the participants' motivation high throughout the study, an online chat group with the
participation of a physician and dietitian, was set up. The study was concluded with 137
patients, because 37 people had left the study by the end of 8 weeks. Total daily energy
expenditures were calculated using the Harris-Benedict formula. Participants in the
time-restricted eating group were allowed to drink calorie-free soda, unsweetened tea, herbal
tea and coffee during their 16-hour fast.
Anthropometric measurements, blood pressure measurements, as well as fasting blood glucose,
ALT (alanine aminotransferase), AST (aspartate aminotransferase), lipid panel and HbA1c
values in blood samples were checked at the start and the end of the study. Body composition
was measured with the bioelectric impedance method with a Tanita Compacto CS 601. The
bioelectrical impedance method is prone to error because of fluctuations in body water
content. However, it is accepted as a valid method for assessing changes in weight loss
studies when duly accompanied by X-ray absorptiometry and reference methods suitable for
evaluating multi-compartment body composition under standard conditions [14]. Waist
circumference, waist-to-hip ratio and waist-to-height ratio (WHtR), which is recently being
recommended, correlate better than BMI in assessing the obesity-related health burden ,
including total mortality rate, type 2 diabetes, and CVD (cardiovascular disease) risk. The
CBC (complete blood count) tests were performed with a Mindrat BC-6800 device, using the SF
Cube technology; biochemical tests were performed with a Roche Cobas C702 device that works
with photometry; and HbA1c tests were performed with an Arkray HA-8180V device that performs
measurements based on the HPLC (High-Performance Liquid Chromatography) technique.
All statistical analyses were performed with the help of SPSS (Statistical Package for the
Social Sciences) v. 25.0. The conformity of variables to the normal distribution pattern were
checked with histogram graphics and Kolmogorov-Smirnov test. Average, standard deviation,
median, IQR (Inter Quantile Range), min.-max. values were used while presenting defining
analyses. Categorical variables were compared with Pearson Chi Square Test. Mann Whitney U
Test was used in examining the nonparametric variants between groups. The Wilcoxon Test was
used for assessing the change in the monitored values within a group, and Repeated Measures
Analysis was used for the same purpose when the comparison was being made between the groups.
Cases where the P value was under 0.05 were taken as statistically significant results.
