- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07066618
- Original Trial
Effects of Meal Energy Density on Body Measures and Metabolism in Women
Effects of Meal Energy Density on Anthropometric Measurements, Some Metabolic Parameters, And Subjective Appetite in Women
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sakarya, Turkey
- Sakarya University of Applied Sciences, Faculty of Sport Sciences, Exercise and Sports Sciences Education, Application and Research Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 20-45
- BMI ≥25 kg/m²
- Regular menstrual cycle
- No chronic disease or medication use
- PSQI ≤5 (Good sleep quality)
Exclusion Criteria:
- Pregnancy or lactation
- Gastrointestinal or metabolic disorders
- Shift workers, sleep disorders
- Medication affecting metabolism
- Weight change >4.5 kg in last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Breakfast Group (BG)
|
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.
|
|
Experimental: Dinner Group (DG)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in fasting blood glucose
Time Frame: Baseline to Week 6
|
Baseline to Week 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in hip circumference
Time Frame: Baseline to Week 6
|
Baseline to Week 6
|
|
Change in HDL cholesterol
Time Frame: Baseline to Week 6
|
Baseline to Week 6
|
|
Change in HbA1c
Time Frame: Baseline to Week 6
|
Baseline to Week 6
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BASKENT-MEALTIME-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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