Nutritional supplement to change body composition in women during perimenopause

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests whether a 12-week nutritional supplement can alter body composition and related metabolic markers in perimenopausal women aged 38-55. Participants will be randomized to receive either the supplement or a placebo, with outcomes including body mass index, body fat composition, plasma and urine metabolites, menopausal symptoms, and physical performance measures like grip strength. The trial uses standard randomized, placebo-controlled design to compare changes between groups over the 12 weeks. Eligible participants are women 38-55 with irregular cycles or menopausal symptoms, not taking other supplements, and without certain exclusion conditions. Primary aim is to determine if the supplement produces meaningful changes in body composition relative to placebo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• NIHR Southampton Clinical Research Facility
  Southampton, Hampshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Colleen S Deane, PhD — University of Southampton
• Study coordinator: Colleen S Deane, PhD
• Email: c.s.deane@soton.ac.uk
• Phone: +44 2381208664

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Collagen and omega-3 supplements in middle-aged women

  This study tests whether taking collagen and omega-3s together improves joint pain, fatigue, sleep, and overall wellbeing in healthy women aged 35–65 compared with a placebo over 8 weeks.

  Recruiting Loughborough University · Loughborough · NCT07740967

• Creatine or placebo to test effects on cognition, muscle strength, and body composition in middle-aged women

  This study tests whether taking creatine daily for 8 weeks improves thinking, strength, fatigue, and body composition in healthy middle-aged women compared to a placebo.

  Recruiting Loughborough University · Loughborough · NCT07729930

• Inulin Prebiotic for Perimenopausal Women with Overweight or Obesity

  This study tests whether 2 weeks of inulin can affect gut and vaginal microbes, heart health, and muscle health in perimenopausal women who are overweight or obese, using a crossover design.

  Recruiting George Washington University · Washington D.C., District of Columbia · NCT07724522

• Probiotic Intake to See If It Helps Perimenopausal Women Think and Feel Better

  We’re testing whether a multi-strain probiotic can improve emotional processing and cognitive function in perimenopausal women who have mood or cognitive concerns.

  Recruiting University of Oxford · Oxford, England · NCT07590999

• Dairy versus plant-based yogurt effects on weight, muscle, bones, and gut bacteria

  This study will test whether eating dairy yogurt instead of a plant-based yogurt (or no yogurt) helps postmenopausal women with overweight or obesity maintain muscle and bone health, control weight, and change gut bacteria.

  Recruiting Laval University · Québec, Quebec · NCT07578103

• Six-month high-fiber, high-polyphenol diet to lower brain inflammation in perimenopausal women with overweight or obesity

  This will try a 6-month high-fiber, high-polyphenol (polybiotic) diet to see if it lowers brain inflammation in perimenopausal women with overweight or obesity.

  Recruiting Max Planck Institute for Human Cognitive and Brain Sciences · Leipzig, Saxony · NCT07501377

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.