NCT05756868

Brief Summary

The goal of this randomized controlled trial is to to determine the effects of time-restricted feeding intervention on body weight, body composition, biochemical parameters and eating behaviors in overweight female individuals. The main questions it aims to answer are:

  1. 1.Does time-restricted feeding intervention reduce daily energy intake?
  2. 2.Does time-restricted dietary intervention result in body weight and body fat loss?
  3. 3.Does time-limited nutritional intervention lead to improvements in biochemical parameters?
  4. 4.Does time-restricted feeding intervention improve eating behavior and eating awareness?
  5. 5.Does time-restricted feeding intervention adversely affect diet quality?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
Last Updated

March 6, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

November 25, 2022

Last Update Submit

March 4, 2023

Conditions

Fasting

Outcome Measures

Primary Outcomes (14)

  • Body Weight

    Body Weight

    6 week

  • Body Composition

    total body fluid

    6 week

  • Body Composition

    total fat mass

    6 week

  • Body Composition

    muscle mass

    6 week

  • Body Composition

    fat free mass

    6 week

  • Plasma lipids

    Total cholesterol

    6 week

  • Plasma lipids

    Hdl cholesterol

    6 week

  • Plasma lipids

    Ldl cholesterol

    6 week

  • Plasma lipids

    Triglyceride

    6 week

  • Blood Pressure

    Systolic blood pressure

    6 week

  • Blood Pressure

    Diastolic blood pressure

    6 week

  • Pulse

    6 week

  • Biochemistry

    blood glucose

    6 week

  • Biochemistry

    fasting insulin

    6 week

Study Arms (2)

Time restricted feeding

EXPERIMENTAL

The participants in the intervention group will receive a time restricted feeding intervention (first meal at 10:00, last meal at 18:00) for 6 weeks. Meals of the participants are planned as 8 hours of eating and 16 hours of fasting.

Behavioral: Time restricted feeding

Control

NO INTERVENTION

Participants in the control group will not receive any dietary intervention. All participants were asked to continue in the same way they were fed before starting the study throughout the study.

Interventions

Time restricted feedingBEHAVIORAL

In the time-restricted nutrition intervention, the first meal is scheduled at 10:00 and the last meal at 18:00 (ad libitum). Eating for 8 hours and fasting for 16 hours are targeted.

Time restricted feeding

Eligibility Criteria

Age19 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age range
  • Female
  • BMI: 24.9-29.9 kg/m²
  • Maintaining general activity and exercise habits during the study period
  • Stable body weight (\<4 kg weight loss or weight gain) for 6 months prior to the start of the study

You may not qualify if:

  • Those with chronic disease (diabetes, hypertension, cardiovascular disease, etc.)
  • Drug users
  • Use of supplements that may affect blood lipid profile and blood sugar (omega-3 etc.)
  • Pregnant women
  • People in the lactation period
  • Menopause
  • Shift workers
  • Those who follow a Time Restricted (16:8) nutrition program before the study
  • Those who have followed any particular diet before the study
  • Those who frequently apply different weight loss diet programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99628, Cyprus

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • AYŞEN YILDIRIM KIZILDAĞ, PhD

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dietitian (MSc)

Study Record Dates

First Submitted

November 25, 2022

First Posted

March 6, 2023

Study Start

September 13, 2021

Primary Completion

October 24, 2021

Study Completion

June 20, 2022

Last Updated

March 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
1 year
Access Criteria
No individual participant data will be shared. Results will be published by the investigators in academic journals.

Locations

CY(1)