Nutritional Supplementation on Physiological and Metabolic Markers in Females

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age38-55
SponsorUniversity of Southampton

About this trial

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

Qualifiers

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

Disqualifiers

Diabetes

BMI <18.5 kg/m2

Pregnant or trying to get pregnant

No active cancer or cancer within last 5 years

Trial design

Treatments tested in this trial

  • Nutritional Supplement
  • Placebo

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Southampton

Lead sponsor

The Better Menopause

Collaborator