NCT07874399Not yet recruiting
Time-Restricted Eating and Personalized Energy-Restricted Diet in Obese Postmenopausal Women
Effects of Time-Restricted Eating and Personalized Energy-Restricted Diet on Menopause Symptoms, Sleep Quality, and Nutritional Status in Obese Postmenopausal Women
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
This clinical study aims to compare the effects of time-restricted eating and a personalized energy-restricted diet on anthropometric measurements, body composition, biochemical parameters, blood pressure, handgrip strength, menopausal symptoms, and sleep quality in obese postmenopausal women. The study is a 12-week, open-label, controlled, parallel-group clinical trial with a quasi-randomized allocation design. The coordinating center is the Department of Internal Medicine, Faculty of Medicine, Gazi University, and the study will be conducted at the Internal Medicine Outpatient Clinic of Cihanbeyli State Hospital in Konya, Türkiye. A total of 40 postmenopausal women are planned to participate, with 20 participants in each group. Participants will undergo an initial medical examination and baseline assessments, including demographic and health information, dietary habits, menopausal symptoms, sleep quality, physical activity, and dietary intake. Anthropometric measurements, body composition, handgrip strength, blood pressure, and biochemical parameters will also be assessed. Participants in the intervention group will follow a time-restricted eating schedule in which they will consume food within an 8-hour daily eating window and fast for 16 hours. The eating window will begin between 8:00 AM and 12:00 PM and will be determined by the participant. During the fasting period, water, unsweetened tea, plain coffee, and plain mineral water will be permitted. Participants in the control group will follow a personalized energy-restricted diet providing approximately 25% less energy than their estimated energy requirements. The diet will be planned according to menopausal nutrition recommendations and individual preferences. Dietary intake will be monitored every 2 weeks. Anthropometric measurements, blood pressure, and handgrip strength will be assessed every 4 weeks. All baseline assessments will be repeated after the 12-week intervention period. The study hypothesis is that time-restricted eating will result in greater improvements than the personalized energy-restricted diet in anthropometric measurements and body composition, biochemical parameters, blood pressure, handgrip strength, menopausal symptoms, and sleep quality in obese postmenopausal women.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 8 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 24 Oct 2027
- Lead sponsor
- Gazi University
- Diseases
- Obesity
- NCT number
- NCT07874399
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Nov 2026 to the primary completion date, 24 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgical menopause
- Current use of hormone replacement therapy
- Current use of weight-loss medications (e.g., orlistat, liraglutide) or diuretics
- Diagnosis of cancer within the previous 5 years
Other illness
- Kidney disease, liver disease (except fatty liver disease), heart failure, type 1 or type 2 diabetes mellitus, or uncontrolled hypertension
- Severe psychiatric disorders (e.g., anxiety disorder or schizophrenia)
- Active metabolic bone diseases (e.g., Paget disease or osteomalacia)
- Diagnosis of an eating disorder
- Current treatment for a sleep disorder
- Conditions requiring a special diet, such as celiac disease
Lab values
- Current use of lipid-lowering, glucose-lowering, antihypertensive, corticosteroid, or anticoagulant medications
Other
- Current smoking and/or alcohol use
- Working night shifts (between 11:00 PM and 6:00 AM)
Who the study is looking for
- Aged 50-60 years
- Body mass index (BMI) ≥30 and ≤40 kg/m²
- No menstrual periods for at least 1 year
- No history of hypoglycemia
- No special diet during the previous 3 months and stable body weight (within ±3 kg)
- Usual daily eating window of ≥10 hours
Age in the registry: 50 years to 60 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cihanbeyli State Hospital Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.