An interventional study of Nutritional Supplement and Placebo in Perimenopausal Women and Body Composition Changes, sponsored by University of Southampton. Recruiting at 1 site in United Kingdom. Open to female participants aged 38 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Southampton · Not applicable, Interventional, and Basic science
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:
Participants will:
Menopause is defined as the reproductive condition of amenorrhea for 12 months, as a result of reduced activity of ovarian follicles and hormonal changes, including oestrogen, androgens, and progesterone. Globally, approximately 47 million females transition into menopause annually. Hormonal decline can reflect in several physical, mental, and genitourinary symptoms. Common physical manifestations include sleep disturbance, hot flushes, mood changes, night sweats, and fatigue.
The current average age at menopause in the United Kingdom is 51 years, typically occurring between 45 and 55; however, a significant number of females experience menopause earlier than expected. When menopause occurs before the normal age, it may be classified as premature (before 40 years), early (between 40-45 years), or induced menopause (result of bilateral oophorectomy with or without hysterectomy, removal of the ovaries and fallopian tubes, or ovarian ablation through radiation therapy).
Menopause-related physical and metabolic changes are mainly a consequence of oestrogen deficiency, affecting lipid metabolism, insulin resistance, energy consumption, and body fat composition. Changes in body composition during menopause often lead to an increase in body mass index (BMI), particularly due to higher fat accumulation and reduced lean muscle mass. During perimenopause, females experience progressive weight gain at an estimated rate of 1.5 kg per year, resulting in an average increase of approximately 10 kg by the time menopause is reached. Higher BMI during menopause has been linked with an elevated risk of cardiovascular and metabolic diseases.
To address these menopause-associated changes, several therapeutic approaches are utilised, including both hormonal and non-hormonal strategies. Natural nutritional supplements have emerged as promising options because of their potential benefits. Among these, cinnamon extracts have gained attention due to their anti-inflammatory, cardiovascular, and immunomodulatory properties, which may alleviate postmenopausal symptoms. Alongside cinnamon, myo-inositol has been shown to alleviate vasomotor symptoms, improving lipid and glucose metabolism and reducing cardiovascular risk factors. By targeting changes in body composition during menopause, nutritional supplements represent a strategic approach to improving quality of life for menopausal females.
University of Southampton is the lead sponsor of 122 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nutritional supplement: * 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.
Dietary Supplement: Nutritional Supplement
Placebo: * 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.
Dietary Supplement: Placebo
Nutritional Supplement (myo-inositol, berberine, cinnamon, chromium) composed of 4 natural bioactives extracted from plants, including fruits, roots, barks, and grains.
Placebo: Maltodextrin
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 intervention
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 intervention
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 intervention
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 intervention
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 intervention
Hand grip dynamometry
To compare the effect of a 12-week nutritional intervention versus placebo on grip strength
Time frame: At the baseline visit and at the end of 12 weeks intervention
Portable strength tracking system
To compare the effect of a 12-week nutritional intervention versus placebo on leg strength
Time frame: At the baseline visit and at the end of the 12-week intervention
Transcriptomic profile of blood sample
To compare the effect of a 12-week nutritional intervention versus placebo on the blood transcriptome
Time frame: At the baseline visit and at the end of the 12-week intervention
Plan to share: No
Started Jul 2026 (actual). Primary completion is estimated for Dec 2027, 17 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 21, 2026: primary completion Dec 2026 → Dec 2027 and completion Dec 2026 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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