ObesityNCT07066618
Effects of Meal Energy Density on Body Measures and Metabolism in Women
A study testing Breakfast-Loaded Hypocaloric Diet and Dinner-Loaded Hypocaloric Diet in people with Obesity and Overweight, run by Melike Nur Eroğlu at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Appetite Regulation
- What is being tested?
- Breakfast-Loaded Hypocaloric Diet and Dinner-Loaded Hypocaloric Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 25 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 20-45
- BMI ≥25 kg/m²
- Regular menstrual cycle
- No chronic disease or medication use
- PSQI ≤5 (Good sleep quality)
Who cannot join
- Pregnancy or lactation
- Gastrointestinal or metabolic disorders
- Shift workers, sleep disorders
- Medication affecting metabolism
- Weight change >4.5 kg in last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University of Applied Sciences, Faculty of Sport Sciences, Exercise and Sports Sciences Education, Application and Research Centre
Sakarya
About this study
Official title: 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.
- Conditions
- Obesity, Overweight, Appetite Regulation, Meal Timing, Circadian Rhythm, Metabolic Health
- Being tested
- Breakfast-Loaded Hypocaloric Diet, Dinner-Loaded Hypocaloric Diet
- Keywords
- circadian rhythm, appetite, Meal Timing, obesity, Glucose Metabolism
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast-Loaded Hypocaloric DietBehavioural
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.
Dinner-Loaded Hypocaloric DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Breakfast Group (BG) | Experimental | Not described Receives: Behavioral: Breakfast-Loaded Hypocaloric Diet |
| Dinner Group (DG) | Experimental | Not described Receives: Behavioral: Dinner-Loaded Hypocaloric Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting blood glucose
Measured: Baseline to Week 6
Secondary outcomes (3)
Change in hip circumference
Measured: Baseline to Week 6
Change in HDL cholesterol
Measured: Baseline to Week 6
Change in HbA1c
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start15 Nov 2023
- Primary completion20 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melike Nur Eroğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melike Nur Eroğlu, Sakarya Applied Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066618
- Sponsor's protocol ID
- BASKENT-MEALTIME-2023
- Status last verified
- Jul 2025
- First submitted
- 15 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Meal Energy Density on Anthropometric Measurements, Some Metabolic Parameters, And Subjective Appetite in Women
- ClinicalTrials.gov ID
- NCT07066618
- Acronym / sponsor ID
- BASKENT-MEALTIME-2023
- Conditions
- Obesity, Overweight, Appetite Regulation, Meal Timing, Circadian Rhythm, Metabolic Health
- Keywords
- circadian rhythm, appetite, Meal Timing, obesity, Glucose Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Melike Nur EroğluUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breakfast Group (BG) | Experimental | Behavioral: Breakfast-Loaded Hypocaloric Diet |
| Dinner Group (DG) | Experimental | Behavioral: Dinner-Loaded Hypocaloric Diet |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 20-45
- BMI ≥25 kg/m²
- Regular menstrual cycle
- No chronic disease or medication use
- PSQI ≤5 (Good sleep quality)
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Gastrointestinal or metabolic disorders
- Shift workers, sleep disorders
- Medication affecting metabolism
- Weight change >4.5 kg in last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breakfast-Loaded Hypocaloric DietParticipants 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. | Behavioural | Breakfast Group (BG) |
| Dinner-Loaded Hypocaloric DietParticipants 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. | Behavioural | Dinner Group (DG) |
Primary outcome
Change in fasting blood glucose
Time frame: Baseline to Week 6
3 secondary outcomes
Change in hip circumference
Time frame: Baseline to Week 6
Change in HDL cholesterol
Time frame: Baseline to Week 6
Change in HbA1c
Time frame: Baseline to Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast-Loaded Hypocaloric Diet and Dinner-Loaded Hypocaloric Diet in people with Obesity and Overweight, run by Melike Nur Eroğlu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting blood glucose (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.