Time-Restricted Eating and Personalized Energy-Restricted Diet in Obese Postmenopausal Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-60
SponsorGazi University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Surgical menopause
Current use of hormone replacement therapy
Current use of lipid-lowering, glucose-lowering, antihypertensive, corticosteroid, or anticoagulant medications
Current use of weight-loss medications (e.g., orlistat, liraglutide) or diuretics
Trial design
Design model
Parallel
Treatments tested in this trial
Time-Restricted Eating
BehavioralParticipants will consume food within an 8-hour daily eating window and fast for 16 hours for 12 weeks. The starting time of the eating window will be selected by the participant between 08:00 and 12:00. During the fasting period, water, unsweetened tea, plain coffee, and plain mineral water will be permitted. No additional energy restriction will be prescribed.
Personalized Energy-Restricted Diet
BehavioralParticipants will follow a personalized energy-restricted diet for 12 weeks, providing approximately 25% less energy than their estimated daily energy requirement. The diet will be planned according to dietary recommendations provided in the guidelines of national and international menopause societies and individual dietary preferences.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Time-Restricted Eating GroupExperimental treatment 1 intervention
Group B: Personalized Energy-Restricted Diet GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in body weight
Change in body weight from baseline to week 12, measured in kilograms (kg). Body weight will be measured at baseline and at weeks 4, 8, and 12 during the intervention.
Time frame
Baseline to Week 122
Change in menopausal symptoms
Change in menopausal symptom severity assessed using the Menopause Rating Scale (MRS). The total score ranges from 0 to 44, with higher scores indicating greater symptom severity.
Time frame
Baseline to Week 123
Change in sleep quality
Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame
Baseline to Week 12Secondary outcomes
1
Change in fat mass
Change in fat mass measured by bioelectrical impedance analysis using the Tanita DC 360, expressed in kilograms, and %.
Time frame
Baseline to Week 122
Change in fat-free mass
Change in fat-free mass measured by bioelectrical impedance analysis using the Tanita DC 360, expressed in kilograms, and %.
Time frame
Baseline to Week 123
Change in body water
Change in body water measured by bioelectrical impedance analysis using the Tanita DC 360, expressed in kilograms, and %.
Time frame
Baseline to Week 124
Change in visceral fat level
Change in body water measured by bioelectrical impedance analysis using the Tanita DC 360
Time frame
Baseline to Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gazi University
Lead sponsor
The Scientific and Technological Research Council of Turkey
Collaborator
Source ClinicalTrials.gov
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