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Not Yet Recruiting NCT07918287

The Role of Diet Quality in Sleep Among Women in Postmenopause

Conditions: Post Menopausal Women

Sex: Female
Ages: 50 Years – 60 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 136
Sponsor: University of Barcelona

Location: Centro de Investigación del Medicamento (CIM Sant Pau) Barcelona

Summary

This single-center, randomized controlled trial with parallel groups, consists of an intensive nutritional intervention based on a high-fiber Mediterranean diet (target intake: 30-35 g/day of dietary fiber), which will be compared with a control group receiving low-intensity nutritional counseling on the Mediterranean diet. The intervention will last 16 weeks, followed by an 8-month follow-up period to evaluate its impact and the sustainability of long-term effects. Participants allocated to the intervention group will receive nutritional counseling and guidance to achieve the intervention target of a daily dietary fiber intake of 30 to 35 g. To this end, they will be provided with a personalized weekly meal plan and will undergo intensive follow-up throughout the intervention period. Participants in the control group will receive educational materials on how to follow a Mediterranean diet; however, no specific dietary fiber intake targets will be established, and they will not receive a personalized weekly meal plan.

Eligibility Criteria

Inclusion Criteria: * Postmenopausal women aged 50 to 60 years * Having a poor subjective sleep quality (assessed using the Pittsburgh Sleep Quality Index, with scores of 5 points or higher) * Having a BMI between 20 and 30 kg/m² * Performing a moderate level of physical activity * Having no recent history of weight changes greater than 2-3 kg during the previous 3 months. Exclusion Criteria: * Having any acute, chronic, or psychiatric illness * Being current smoker * Taking antibiotics * Following a specific diet or have dietary restrictions * Work rotating or night shifts * Have undergone bariatric surgery or endoscopic bariatric procedures * Being unable to provide written informed consent.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07918287). StuddyBuddy aggregates publicly available trial information.