Dietary supplementation on physiological/metabolic markers in females
Research type
Research Study
Full title
A pilot study investigating the effects of a dietary supplement on physiological and metabolic markers in 38-55 year old females.
IRAS ID
368520
Contact name
Colleen S Deane
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
Many women experience physical and metabolic changes during the menopause transition, including weight gain, changes in body fat distribution, reduced muscle strength, sleep disturbance and low mood. These changes are partly linked to hormonal shifts and may increase the risk of longer-term health conditions such as cardiovascular disease and diabetes. There is growing interest in non-hormonal approaches, including nutritional supplements, that may help manage these changes.
This study aims to investigate whether a 12-week dietary supplement changes body weight and metabolic-related markers in women aged 38–55 who are experiencing menopause-related changes.
Eighty participants will be randomly allocated to receive either the dietary supplement or a placebo for 12 weeks. Neither the participants nor the research team will know which capsules are being taken until the end of the study. The supplement contains naturally derived ingredients that are widely available over the counter (myo-inositol, berberine, Cinnasil® (cinnamon) and chromium).
Participants will attend two study visits at the NIHR Clinical Research Facility in Southampton (at the start and after 12 weeks). At these visits we will measure height, weight, body composition, waist and hip measurements, and muscle strength. Blood and urine samples will be collected to examine metabolic markers. Participants will also complete short questionnaires about diet, physical activity, alcohol intake and menopause-related changes during the study.
The findings will help us understand whether this dietary supplement may support physiological and metabolic changes during the menopause transition.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
26/SC/0096
Date of REC Opinion
6 May 2026
REC opinion
Further Information Favourable Opinion