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NCT07615777
Nutritional Supplementation on Physiological and Metabolic Markers in Females
Conditions: Perimenopausal Women, Body Composition Changes
Sex: Female
Ages: 38 Years – 55 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 80
Sponsor: University of Southampton
Location: NIHR Southampton Clinical Research Facility Southampton Hampshire
Summary
The goal of this clinical trial is to learn if a 12-week nutritional supplement can result in significant changes in the body composition of 38-55-year-old females. The main questions it aims to answer are:
* Does a 12-week nutritional supplementation with myo-inositol, berberine, cinnamon, and chromium lead to significant changes in body composition (e.g. body mass index, body fat composition) in females aged 38-55 compared to placebo?
* Does a 12-week nutritional supplementation with myo-inositol, berberine, cinnamon, and chromium lead to significant changes in small molecules (metabolites) in plasma and urine, menopause-related symptoms, and physical performance (e.g. grip strength) in females aged 38-55 compared to placebo? Researchers will compare the nutritional supplement to a placebo (a look-alike substance that contains no nutritional supplement) to see if the intervention works to change body composition in females aged 38-55.
Participants will:
* Sign a consent form before any procedures begin
* Attend two visits to the clinical research facility at Southampton General Hospital over 12 weeks.
* Fast before visit's and provide blood and urine samples at each visit
* Undergo measurements at each visit, including waist and hip circumferences, grip and leg strength, and body composition.
* Complete questionnaires about general health, menopause-related changes, alcohol consumption, physical activity, and diet.
* Take 1 capsule 3 times a day at the onset of a meal (once in the morning, once at midday, and once in the evening) for the first 10 days.
* Take 3 capsules 3 times a day at the onset of a meal (once in the morning, once at midday, and once in the evening) from day 11 to day 84.
* Record supplement intake in a daily compliance diary during the study
Eligibility Criteria
Inclusion Criteria:
* Assigned sex at birth is female
* Aged 38-55 years
* Experiencing irregular menstrual cycles but not amenorrheic for more than 12 months or have at least one of the following recent symptoms (i.e., from 38 years onwards): (1) hot flushes, (2) sleep disturbances, (3) mood swings, (4) concentration difficulties, (5) bloating or (6) weight gain.
* Willing to avoid taking other food supplements during the study period
* Able to provide written informed consent
Exclusion Criteria:
* Diabetes
* BMI \
Source: ClinicalTrials.gov (NCT07615777). StuddyBuddy aggregates publicly available trial information.