Nutritional Supplementation on Physiological and Metabolic Markers in Females

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
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Record History

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  1. Primary and study completion pushed from Dec 2026 to Dec 2027
    • Eligibility criteria expanded, about 14 words
    • Publications: details revised at 18 of 18 entries
  2. Recruitment opened
    • Start date changed from estimate of Jun 1, 2026 to Jul 9, 2026
    • Site details revised
    v3
  3. Study description shortened, about 76 wordsv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07615777
Lead Sponsor University of Southampton
Collaborators: The Better Menopause
Conditions
(from sponsor)		 Perimenopausal Women, Body Composition Changes
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov