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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Nutritional Supplement
Dietary supplementNutritional Supplement (myo-inositol, berberine, cinnamon, chromium) composed of 4 natural bioactives extracted from plants, including fruits, roots, barks, and grains.
Placebo
Dietary supplementPlacebo: Maltodextrin
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Nutritional supplementExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Body mass index
To compare the body mass index by measuring the weight after 12-week intervention
Time frame
At the baseline visit and at the end of 12 weeks interventionSecondary outcomes
1
Body fat composition
To compare the effect of a 12-week nutritional intervention versus placebo by measuring Waist and hip circumferences
Time frame
At the baseline visit and at the end of the 12-week intervention2
Metabolomic profile of the plasma sample
To compare the effect of a 12-week nutritional intervention to a placebo on the plasma metabolome
Time frame
At the baseline visit and at the end of 12 weeks intervention3
Metabolomic profile of a urine sample
To compare the effect of a 12-week nutritional intervention versus placebo on the urinary metabolome.
Time frame
At the baseline visit and at the end of 12 weeks intervention4
Menopause-related changes
To compare the effect of a 12-week nutritional intervention on self-reported menopause-related changes versus placebo.
Time frame
At the baseline visit and at the end of 12 weeks interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southampton
Lead sponsor
The Better Menopause
Collaborator
Source ClinicalTrials.gov