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Two Different Dietary Approaches in Body Composition

NCT06139562 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-18

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • Baskent University

    lead OTHER

Principal Investigators

  • Emel Aydan Oral, Instructor · Baskent University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2020-10-21
Completion
2020-10-21

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06139562 on ClinicalTrials.gov