CClinicalTrials.gg
CompletedNCT06139562Updated Nov 18, 2023

Two Different Dietary Approaches in Body Composition

An interventional study of Time-Restricted Feeding and Extended-Time Feeding in Time Restricted Feeding and Obesity, sponsored by Baskent University. Completed at 1 site in Turkey. Open to female participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Baskent University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Sep 2019, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Time Restricted Feeding
  • Obesity

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Keywords

  • Obesity
  • Time restricted feeding
  • Hormone
  • Anthropometric measurements
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 20 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Baskent University is the lead sponsor of 201 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion criteria

Exclusion Criteria:

  • Women who were in menopause
  • Having eating disorders
  • Having psychiatric illnesses
  • Having metabolic and chronic diseases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Time-Restricted Feeding (TRF)

    Time-restricted feeding program from sunrise to sunset

    Behavioral: Time-Restricted Feeding · Behavioral: Extended-Time Feeding

  • Active comparator
    Extended-Time Feeding (ETF)

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

    Behavioral: Time-Restricted Feeding · Behavioral: Extended-Time Feeding

Interventions

  • BehavioralTime-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.

  • BehavioralExtended-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.

06

What researchers measure

Primary outcomes

  1. Leptin

    ng/mL

    Time frame: At the beginning and end of each intervention

  2. Ghrelin

    pg/mL

    Time frame: At the beginning and end of each intervention

  3. Body Weight

    kg

    Time frame: At the beginning and end of each intervention

  4. Body Mass Index (BMI)

    kg/m2

    Time frame: At the beginning and end of each intervention

  5. Body Fat Mass

    kg

    Time frame: At the beginning and end of each intervention

07

Study locations

1 site
  • Baskent University
    Ankara, Turkey
08

References and documents

Publications

  • Ravussin E, Beyl RA, Poggiogalle E, Hsia DS, Peterson CM. Early Time-Restricted Feeding Reduces Appetite and Increases Fat Oxidation But Does Not Affect Energy Expenditure in Humans. Obesity (Silver Spring). 2019 Aug;27(8):1244-1254. doi: 10.1002/oby.22518. PubMed 31339000 ↗
  • de Oliveira Maranhao Pureza IR, da Silva Junior AE, Silva Praxedes DR, Lessa Vasconcelos LG, de Lima Macena M, Vieira de Melo IS, de Menezes Toledo Florencio TM, Bueno NB. Effects of time-restricted feeding on body weight, body composition and vital signs in low-income women with obesity: A 12-month randomized clinical trial. Clin Nutr. 2021 Mar;40(3):759-766. doi: 10.1016/j.clnu.2020.06.036. Epub 2020 Jul 14. PubMed 32713721 ↗
  • Rynders CA, Thomas EA, Zaman A, Pan Z, Catenacci VA, Melanson EL. Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. Nutrients. 2019 Oct 14;11(10):2442. doi: 10.3390/nu11102442. PubMed 31614992 ↗
  • Schroder JD, Falqueto H, Manica A, Zanini D, de Oliveira T, de Sa CA, Cardoso AM, Manfredi LH. Effects of time-restricted feeding in weight loss, metabolic syndrome and cardiovascular risk in obese women. J Transl Med. 2021 Jan 6;19(1):3. doi: 10.1186/s12967-020-02687-0. PubMed 33407612 ↗
  • Stratton MT, Tinsley GM, Alesi MG, Hester GM, Olmos AA, Serafini PR, Modjeski AS, Mangine GT, King K, Savage SN, Webb AT, VanDusseldorp TA. Four Weeks of Time-Restricted Feeding Combined with Resistance Training Does Not Differentially Influence Measures of Body Composition, Muscle Performance, Resting Energy Expenditure, and Blood Biomarkers. Nutrients. 2020 Apr 17;12(4):1126. doi: 10.3390/nu12041126. PubMed 32316561 ↗
  • Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10. PubMed 29754952 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06139562
Lead sponsor
Baskent University
Responsible party
Emel Aydan Oral (Instructor, Baskent University) — Principal investigator
First posted
Nov 18, 2023
Start date
Sep 27, 2019
Primary completion
Oct 21, 2020
Completion
Oct 21, 2020
Last update
Nov 18, 2023

Study contacts

Emel Aydan Oral, Instructor
principal investigator · Baskent University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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