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Time Restricted FeedingNCT06139562

Two Different Dietary Approaches in Body Composition

A study testing Time-Restricted Feeding and Extended-Time Feeding in people with Time Restricted Feeding and Obesity, run by Baskent University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Time Restricted Feeding, Obesity
What is being tested?
Time-Restricted Feeding and Extended-Time Feeding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
27 Sep 2019to 21 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Baskent University

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Two Different Dietary Approaches In Body Composition And Serum Hormone Levels: Time-Restricted And Extended Feeding

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.

Being tested
Time-Restricted Feeding, Extended-Time Feeding
Keywords
Obesity, Time restricted feeding, Hormone, Anthropometric measurements
Medical subject headings
Intermittent Fasting, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time-Restricted FeedingBehavioural

    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 FeedingBehavioural

    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.

Study groups in NCT06139562
Study groupRoleWhat they receive
Time-Restricted Feeding (TRF)ExperimentalTime-restricted feeding program from sunrise to sunset
Receives: Behavioral: Time-Restricted Feeding; Behavioral: Extended-Time Feeding
Extended-Time Feeding (ETF)Active comparatorExtended-time feeding program that allows them to eat at any time of the day
Receives: Behavioral: Time-Restricted Feeding; Behavioral: Extended-Time Feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Leptin

    ng/mL

    Measured: At the beginning and end of each intervention

  2. Ghrelin

    pg/mL

    Measured: At the beginning and end of each intervention

  3. Body Weight

    kg

    Measured: At the beginning and end of each intervention

  4. Body Mass Index (BMI)

    kg/m2

    Measured: At the beginning and end of each intervention

  5. Body Fat Mass

    kg

    Measured: At the beginning and end of each intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start27 Sep 2019
  3. Primary completion21 Oct 2020
  4. Study completion21 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06139562
Sponsor's protocol ID
Nutrition
Status last verified
Nov 2023
First submitted
9 Nov 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Time-Restricted Feeding and Extended-Time Feeding in people with Time Restricted Feeding and Obesity, run by Baskent University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Leptin (time frame: At the beginning and end of each intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06139562, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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