NCT07066618

Brief Summary

This study investigates whether the timing of energy intake during the day-specifically consuming more calories at breakfast or at dinner-affects body measurements, blood sugar levels, cholesterol, and feelings of hunger in women who are overweight or obese. A total of 28 women participated in the study and were randomly assigned to one of two diet plans: one group consumed half of their daily calories at breakfast, while the other consumed them at dinner. Both groups followed a calorie-restricted diet for six weeks. The goal of this research is to understand whether eating more in the morning rather than in the evening leads to better outcomes for weight control and metabolic health. Findings from this study may help health professionals make more effective meal timing recommendations for weight loss and improving blood sugar regulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable obesity

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

November 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

June 15, 2025

Last Update Submit

July 4, 2025

Conditions

ObesityOverweightAppetite RegulationMeal TimingCircadian RhythmMetabolic Health

Keywords

circadian rhythmappetiteMeal TimingobesityGlucose Metabolism

Outcome Measures

Primary Outcomes (1)

  • Change in fasting blood glucose

    Baseline to Week 6

Secondary Outcomes (3)

  • Change in hip circumference

    Baseline to Week 6

  • Change in HDL cholesterol

    Baseline to Week 6

  • Change in HbA1c

    Baseline to Week 6

Study Arms (2)

Breakfast Group (BG)

EXPERIMENTAL
Behavioral: Breakfast-Loaded Hypocaloric Diet

Dinner Group (DG)

EXPERIMENTAL
Behavioral: Dinner-Loaded Hypocaloric Diet

Interventions

Breakfast-Loaded Hypocaloric DietBEHAVIORAL

Participants in this group consumed a hypocaloric diet in which 50% of daily energy intake was provided at breakfast, 35% at lunch, and 15% at dinner. Meal times were standardized as follows: breakfast (7:00-9:00), lunch (12:00-14:00), and dinner (18:00-20:00). The diet was individually tailored and provided 20% fewer calories than the participants' total energy expenditure. Macronutrient distribution followed recommended guidelines: 45-60% carbohydrates, 10-20% protein, and 20-35% fat.

Breakfast Group (BG)
Dinner-Loaded Hypocaloric DietBEHAVIORAL

Participants in this group consumed a hypocaloric diet in which 15% of daily energy intake was provided at breakfast, 35% at lunch, and 50% at dinner. Meal times were standardized as follows: breakfast (7:00-9:00), lunch (12:00-14:00), and dinner (18:00-20:00). The diet was individually tailored and provided 20% fewer calories than the participants' total energy expenditure. Macronutrient distribution followed recommended guidelines: 45-60% carbohydrates, 10-20% protein, and 20-35% fat.

Dinner Group (DG)

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 20-45
  • BMI ≥25 kg/m²
  • Regular menstrual cycle
  • No chronic disease or medication use
  • PSQI ≤5 (Good sleep quality)

You may not qualify if:

  • Pregnancy or lactation
  • Gastrointestinal or metabolic disorders
  • Shift workers, sleep disorders
  • Medication affecting metabolism
  • Weight change \>4.5 kg in last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University of Applied Sciences, Faculty of Sport Sciences, Exercise and Sports Sciences Education, Application and Research Centre

Sakarya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

June 15, 2025

First Posted

July 15, 2025

Study Start

November 15, 2023

Primary Completion

March 20, 2024

Study Completion

March 25, 2024

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Locations

TU(1)