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Nutritional Supplementation on Physiological and Metabolic Markers in Females

RecruitingNAAges 38 Years - 55 YearsFemaleUniversity of Southampton
NCT07615777 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 work

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📋 Eligibility rules (as published)
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 \<18.5 kg/m2 * Pregnant or trying to get pregnant * No active cancer or cancer within last 5 years * Total Hysterectomy * Known allergies to cinnamon extract, chromium, berberine, myo-inositol * Currently taking part in research, or have done within the last 3 months * Diagnosed autoimmune diseases * Diagnosed hypoglycemia
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What it tests

  • Nutritional Supplement
  • Placebo
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Where

1 site
NIHR Southampton Clinical Research Facility
Southampton, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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