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Nutritional Supplementation on Physiological and Metabolic Markers in Females

NCT07615777 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-29

No results posted yet for this study

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

Conditions

  • Perimenopausal Women
  • Body Composition Changes

Interventions

DIETARY_SUPPLEMENT

Nutritional Supplement

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

DIETARY_SUPPLEMENT

Placebo

Placebo: Maltodextrin

Sponsors & Collaborators

  • The Better Menopause

    collaborator UNKNOWN

  • University of Southampton

    lead OTHER

Principal Investigators

  • Colleen S Deane, PhD · University of Southampton

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
38 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07615777 on ClinicalTrials.gov