Clinical Research Directory

Time-Restricted Eating and Personalized Energy-Restricted Diet in Obese Postmenopausal Women

Sponsor: Gazi University

Summary

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.

Official title: Effects of Time-Restricted Eating and Personalized Energy-Restricted Diet on Menopause Symptoms, Sleep Quality, and Nutritional Status in Obese Postmenopausal Women

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