NCT07826065

Brief Summary

This study was conducted to compare the effects of a 12-week 16:8 Time-Restricted Feeding (Intermittent Fasting) + home-based exercise protocol with and a calorie-restricted Standard Diet (SD) + home-based exercise protocol on body composition, lipid profile, glycemic control, and liver function enzyme levels in obese women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

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

May 2, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

September 12, 2026

Last Update Submit

September 18, 2026

Conditions

Obesity & Overweight

Keywords

Intermittent FastingTime-Restricted FeedingObesityBody CompositionALTExercise

Outcome Measures

Primary Outcomes (12)

  • Change in Fasting Blood Glucose

    Evaluation of changes in fasting blood glucose levels.

    Baseline and 12 weeks

  • Change in HOMA-IR Index

    Evaluation of changes in insulin resistance index.

    Baseline and 12 weeks

  • Change in Lipid Profile Parameters

    Evaluation of changes in serum total cholesterol, triglycerides, HDL, and LDL levels.

    Baseline and 12 weeks

  • Change in Serum ALT Level

    Evaluation of changes in alanine aminotransferase enzyme levels.

    Baseline and 12 weeks

  • Change in Serum AST Level

    Evaluation of changes in aspartate aminotransferase enzyme levels.

    Baseline and 12 weeks

  • Change in Body Mass Index (BMI)

    Evaluation of changes in body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²).

    Baseline and 12 weeks

  • Change in Body Weight

    Evaluation of changes in body weight in kilograms.

    Baseline and 12 weeks

  • Change in Body Fat Percentage

    Evaluation of changes in body fat percentage assessed via Bioelectrical Impedance Analysis (BIA).

    Baseline and 12 weeks

  • Change in Total Cholesterol

    Evaluation of changes in serum total cholesterol levels (mg/dL).

    Baseline and 12 weeks

  • Change in Triglycerides

    Evaluation of changes in serum triglyceride levels (mg/dL).

    Baseline and 12 weeks

  • Change in HDL Cholesterol

    Evaluation of changes in high-density lipoprotein cholesterol levels (mg/dL).

    Baseline and 12 weeks

  • Change in LDL Cholesterol

    Evaluation of changes in low-density lipoprotein cholesterol levels (mg/dL).

    Baseline and 12 weeks

Study Arms (3)

Intermittent Fasting

EXPERIMENTAL
Other: 16:8 Time-Restricted Feeding and Exercise

Standart Diet

ACTIVE COMPARATOR
Other: Standart Diet and Exercise

Control Group

NO INTERVENTION

Interventions

16:8 Time-Restricted Feeding and ExerciseOTHER

Participants followed a 16:8 time-restricted feeding protocol (fasting for 16 hours and consuming all daily caloric intake within an 8-hour window) combined with a structured home-based exercise program for 12 weeks.

Intermittent Fasting
Standart Diet and ExerciseOTHER

Participants followed a standard energy-restricted diet distributed across regular daily meals combined with a structured home-based exercise program for 12 weeks

Standart Diet

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index between 30 and 40
  • Female
  • Agreeing to adhere to a calorie-restricted diet
  • Agreeing to adhere to an exercise program

You may not qualify if:

  • Having cancer, diabetes, or thyroid disease
  • Having received assistance with weight loss in the last 3 months
  • Inability to adhere to calorie restriction
  • Failure to adhere to an exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Kayseri, 38100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityOverweightIntermittent FastingMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

September 12, 2026

First Posted

September 17, 2026

Study Start

May 2, 2025

Primary Completion

July 1, 2026

Study Completion

August 20, 2026

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)