RecruitingNot ApplicableNCT07615777

Nutritional Supplementation on Physiological and Metabolic Markers in Females

A Pilot Study Investigating the Effects of a Nutritional Supplement on Physiological and Metabolic Markers in 38-55-year-old Females


Sponsor

University of Southampton

Enrollment

80 participants

Start Date

Jul 9, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 38 YearsMax Age: 55 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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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Interventions

DIETARY_SUPPLEMENTNutritional Supplement

Nutritional Supplement (myo-inositol, berberine, cinnamon, chromium) composed of 4 natural bioactives extracted from plants, including fruits, roots, barks, and grains.

DIETARY_SUPPLEMENTPlacebo

Placebo: Maltodextrin


Locations(1)

NIHR Southampton Clinical Research Facility

Southampton, Hampshire, United Kingdom

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NCT07615777


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