Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364475
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-04-04
Brief Title:
Could a Time-restricted Diet Compete With a Calorie-restricted 6-meal Diet
Sponsor:
Bezmialem Vakif University
Organization:
Bezmialem Vakif University
Study Overview
Official Title:
Comparing the Effects of Time-restricted Eating and Three Meals-three Snacks Diet on Body Composition and on Biochemical Parameters
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 BMI25 kgm2 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
Detailed Description:
Our study was conducted with participants aged between 18-65 and with a BMI 25 kgm2 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 TM with G Power 3197 Franz Faul Germany using data from Sundfør et als 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 0382 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 168 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 250 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 005 were taken as statistically significant results
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 168 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 250 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 005 were taken as statistically significant results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None