NCT06139562

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2020

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

November 9, 2023

Last Update Submit

November 14, 2023

Conditions

Time Restricted FeedingObesity

Keywords

ObesityTime restricted feedingHormoneAnthropometric measurements

Outcome Measures

Primary Outcomes (5)

  • Leptin

    ng/mL

    At the beginning and end of each intervention

  • Ghrelin

    pg/mL

    At the beginning and end of each intervention

  • Body Weight

    kg

    At the beginning and end of each intervention

  • Body Mass Index (BMI)

    kg/m2

    At the beginning and end of each intervention

  • Body Fat Mass

    kg

    At the beginning and end of each intervention

Study Arms (2)

Time-Restricted Feeding (TRF)

EXPERIMENTAL

Time-restricted feeding program from sunrise to sunset

Behavioral: Time-Restricted FeedingBehavioral: Extended-Time Feeding

Extended-Time Feeding (ETF)

ACTIVE COMPARATOR

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

Behavioral: Time-Restricted FeedingBehavioral: Extended-Time Feeding

Interventions

Time-Restricted FeedingBEHAVIORAL

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 (ETF)Time-Restricted Feeding (TRF)
Extended-Time FeedingBEHAVIORAL

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)Time-Restricted Feeding (TRF)

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 31339000BACKGROUND

  • 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.

    PMID: 32713721RESULT

  • 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.

    PMID: 31614992RESULT

  • 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.

    PMID: 33407612RESULT

  • 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.

    PMID: 32316561RESULT

  • 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.

    PMID: 29754952RESULT

MeSH Terms

Conditions

Intermittent FastingObesity

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emel Aydan Oral, Instructor

    Baskent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 18, 2023

Study Start

September 27, 2019

Primary Completion

October 21, 2020

Study Completion

October 21, 2020

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)