Two Different Dietary Approaches in Body Composition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-27

Study Completion Date

2020-10-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Objective: In this study, it was aimed to determine the effect of time-restricted feeding on anthropometric measurements and leptin, ghrelin, adiponectin, insulin and cortisol hormone levels in obese women.

Material and Methods: This study was carried out with women who voluntarily accepted to participate in the study who applied to the Baskent University Ankara Hospital Endocrinonogy Outpatient Clinic between September 2019 and October 2020. Women between the ages of 20 and 50, with a body mass index of 29-35 kg/m2, without any chronic disease, who did not have a weight loss diet in the last 6 months, and who had regular night sleep were included in the study. This study was planned as a randomized cross-over design for a total of 9 weeks. Two different dietary interventions, "time-restricted feeding" and "extended-time feeding", were applied to 4 weeks for each group and a week for wash-out period. Anthropometric measurements and hormone levels of individuals were evaluated at the beginning and end of the study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Early vs. Delayed Time-Restricted Eating on Metabolic Syndrome Parameters

NCT07096505

Obesity and Metabolic Syndrome

COMPLETED NA

Effect of Low-calorie Diet on Serum Lipids, Adipokines, Insulin Resistance and Also Body Composition in Women With Metabolic Syndrome

NCT02087709

Weight Loss Insulin Resistance Adipokines

COMPLETED NA

Classic vs. High-Fat Intermittent Fasting Effects

NCT06515639

Obesity

COMPLETED NA

Effect of Low Glycemic Index Diet on Biochemical Parameters and Body Image in Obesity With Insulin Resistance: A Randomized Clinical Trial

NCT05787314

Obesity

COMPLETED NA

Meal Pattern and Metabolic Parameters

NCT02582606

Insulin Resistance

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study was conducted on volunteers who applied to Başkent University Ankara Hospital Endocrinonogy Outpatient Clinic between September 2019 and October 2020. The study was conducted on women between the ages of 20-50 years, with a body mass index (BMI) between 29-35 kg/m2, sedentary lifestyle, working day shift, regular night sleep habits (bedtime 10:00-12.00 pm; waking time 06:00-08:00 am), without any chronic disease, no dieting history in the last 6 months. Women who were in menopause, with eating disorders, psychiatric illnesses, metabolic and chronic diseases were excluded in the study. As the cross over design study was planned which in the comparison of any quantitative measurement, it was found appropriate to work with at least 29 people in order to reveal a medium to large effect size with a 5% Type I error probability and 86% power probability within the knowledge of the literature. PASS Power Software 3.1.3 for power analysis software was used.A total of 30 women participated in the study. The individuals were randomly divided into 2 groups as Group I (n:15) and Group II (n:15). This study was planned to be a randomized study with a cross-over design for a total of 9 weeks. The study was a two-armed study and two different dietary interventions were applied to the groups: "Time-Restricted Feeding (TRF)" and "Extended-Time Feeding (ETF)". A 1-week washout period was given between two 4-week dietary intervention periods. Ten subjects withdrawn from the study after the first dietary interventon period. A total of 20 people completed the study .At the beginning of the study, a questionnaire (demographic characteristics, educational status, occupation, family history, eating habits and sleep patterns, etc.) was applied to all individuals participating in the study by face-to-face interview method.Since there is no standard definition of TRF, fasting/feeding periods vary. In this study, 12-hour fasting and 12-hour feeding period defined by Pureza et al. were taken as the TRF model. In the first 4-week arm of the study, Group I applied a time-restricted feeding program from sunrise to sunset; for Group II, an extended-time feeding program was suggested that allows them to eat at any time of the day. During dietary interventions, a weight loss diet was applied to the participants. The daily energy requirements of the participants were calculated individually to lose 5% of their initial weight and the distributions of macronutrients were 45-60% of total energy from carbohydrates, 10-20% as protein and less than 35% from fat. Before dietary interventions a 60-minute informative meeting was held by the researcher dietitian, in which the food portion and amount were explained by using the visual food catalog.Anthropometric measurement and body composition were assessed at the beginning and end of each intervention.Serum hormone levels were analyzed at Baskent University Ankara Hospital Biochemistry Laboratory. Blood samples were taken from the patients at the beginning of the study and at the end of each period.Qualitative variables are given as number (S) and percentage (%). Continuous variables (quantitative variables) obtained by measurement are given with mean and standard deviation (¬x̄ ±SD) values. The conformity of the data obtained from the measured quantitative variables to the normal distribution was evaluated with the "Shapiro Wilk Test". Chi-Square (Chi-Square) test was used to determine the relationship or difference between qualitative variables. At the beginning of the study, the "Independent Samples T Test" was used to compare the averages of some quantitative variables according to the diet. "Paired Samples T-Test (T-Test in Dependent Groups)" was used to evaluate the groups within themselves. The criterion of "effect size (d=effect size) obtained from the comparison of dependent/independent groups" was used to determine the degree of effect of dietary interventions on individuals' hormone levels and anthropometric measurements. "Pearson Correlation Coefficent" and "Partial Correlation Coefficent" after removing the initial body weight were used to determine the relationship between quantitative variables. P\<0.05 was accepted as the level of significance in all statistical analyses. The data obtained according to the results of the study were evaluated with the SPSS 25 (Statistical Package for Social Sciences) statistical package program.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Time Restricted Feeding Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Time-Restricted Feeding (TRF)

Time-restricted feeding program from sunrise to sunset

Group Type EXPERIMENTAL

Time-Restricted Feeding

Intervention Type BEHAVIORAL

Time-restricted feeding (TRF) is a dietary approach that includes a fasting protocol and a fasting period ranging from 3 to 21 hours during the day . Since there is no standard definition of TRF, fasting/feeding periods vary. In this study, 12-hour fasting and 12-hour feeding period defined by Pureza et al.(11) were taken as the TRF model. In the first 4-week arm of the study, applied a time-restricted feeding program from sunrise to sunset. The daily energy requirements of the participants were calculated individually to lose 5% of their initial weight and the distributions of macronutrients were 45-60% of total energy from carbohydrates, 10-20% as protein and less than 35% from fat.

Extended-Time Feeding

Intervention Type BEHAVIORAL

Extended-time feeding program was suggested that allows them to eat at any time of the day. During dietary interventions, a weight loss diet was applied to the participants. The daily energy requirements of the participants were calculated individually to lose 5% of their initial weight and the distributions of macronutrients were 45-60% of total energy from carbohydrates, 10-20% as protein and less than 35% from fat.

Extended-Time Feeding (ETF)

Extended-time feeding program that allows them to eat at any time of the day

Group Type ACTIVE_COMPARATOR

Time-Restricted Feeding

Intervention Type BEHAVIORAL

Time-restricted feeding (TRF) is a dietary approach that includes a fasting protocol and a fasting period ranging from 3 to 21 hours during the day . Since there is no standard definition of TRF, fasting/feeding periods vary. In this study, 12-hour fasting and 12-hour feeding period defined by Pureza et al.(11) were taken as the TRF model. In the first 4-week arm of the study, applied a time-restricted feeding program from sunrise to sunset. The daily energy requirements of the participants were calculated individually to lose 5% of their initial weight and the distributions of macronutrients were 45-60% of total energy from carbohydrates, 10-20% as protein and less than 35% from fat.

Extended-Time Feeding

Intervention Type BEHAVIORAL

Extended-time feeding program was suggested that allows them to eat at any time of the day. During dietary interventions, a weight loss diet was applied to the participants. The daily energy requirements of the participants were calculated individually to lose 5% of their initial weight and the distributions of macronutrients were 45-60% of total energy from carbohydrates, 10-20% as protein and less than 35% from fat.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Time-Restricted Feeding

Time-restricted feeding (TRF) is a dietary approach that includes a fasting protocol and a fasting period ranging from 3 to 21 hours during the day . Since there is no standard definition of TRF, fasting/feeding periods vary. In this study, 12-hour fasting and 12-hour feeding period defined by Pureza et al.(11) were taken as the TRF model. In the first 4-week arm of the study, applied a time-restricted feeding program from sunrise to sunset. The daily energy requirements of the participants were calculated individually to lose 5% of their initial weight and the distributions of macronutrients were 45-60% of total energy from carbohydrates, 10-20% as protein and less than 35% from fat.

Intervention Type BEHAVIORAL

Extended-Time Feeding

Extended-time feeding program was suggested that allows them to eat at any time of the day. During dietary interventions, a weight loss diet was applied to the participants. The daily energy requirements of the participants were calculated individually to lose 5% of their initial weight and the distributions of macronutrients were 45-60% of total energy from carbohydrates, 10-20% as protein and less than 35% from fat.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women between the ages of 20-50 years
* Body mass index (BMI) between 29-35 kg/m2
* Sedentary lifestyle
* Working day shift
* Regular night sleep habits (bedtime 10:00-12.00 pm; waking time 06:00-08:00 am)
* Without any chronic disease
* No dieting history in the last 6 months