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