Perimenopausal WomenNCT07615777
Nutritional Supplementation on Physiological and Metabolic Markers in Females
A study testing Nutritional Supplement in people with Perimenopausal Women and Body Composition Changes, run by University of Southampton at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 38 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopausal Women, Body Composition Changes
- What is being tested?
- Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jul 2026to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Currently taking part in research, or have done within the last 3 months
- Diagnosed autoimmune diseases
- Diagnosed hypoglycemia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
NIHR Southampton Clinical Research Facility
Southampton, Hampshire, SO16 6YD
Clinical Research Facility, 02381204989, crfstudyteam@uhs.nhs.uk
About this study
Official title: A Pilot Study Investigating the Effects of a Nutritional Supplement on Physiological and Metabolic Markers in 38-55-year-old Females
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.
Read more
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
Read the detailed description
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.
- Conditions
- Perimenopausal Women, Body Composition Changes
- Being tested
- Nutritional Supplement, Placebo
- Keywords
- Perimenopause, menopause, metabolism, metabolomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional SupplementDietary supplement
Nutritional Supplement (myo-inositol, berberine, cinnamon, chromium) composed of 4 natural bioactives extracted from plants, including fruits, roots, barks, and grains.
PlaceboDietary supplement
Placebo: Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Nutritional supplement | Experimental | 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. Receives: Dietary Supplement: Nutritional Supplement |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
To compare the body mass index by measuring the weight after 12-week intervention
Measured: At the baseline visit and at the end of 12 weeks intervention
Secondary outcomes (7)
Body fat composition
To compare the effect of a 12-week nutritional intervention versus placebo by measuring Waist and hip circumferences
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: At the baseline visit and at the end of the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start9 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Perimenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A n = 80 females (2 treatment arms, each n=40), providing participants with either myo-inositol (2064mg/day), berberine (400mg/day), Cinnasil® (250mg/day) and chromium picolinate (3402mg/day) or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- The Better Menopause
- Responsible party
- Sponsor
- Investigators
- Colleen S Deane, PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615777
- Sponsor's protocol ID
- ERGO111652
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mainini G, Ercolano S, De Simone R, Iavarone I, Lizza R, Passaro M. Dietary Supplementation of Myo-Inositol, Cocoa Polyphenols, and Soy Isoflavones Improves Vasomotor Symptoms and Metabolic Profile in Menopausal Women with Metabolic Syndrome: A Retrospective Clinical Study. Medicina (Kaunas). 2024 Apr 4;60(4):598. doi: 10.3390/medicina60040598.
PubMed 38674244Refaei M, Karami Z, Kazemi F, Moradkhani S, Masoumi SZ, Jenabi E, Jafari M. Cinnamon potential in alleviating early postmenopause symptoms: a randomized clinical trial. Menopause. 2024 Dec 1;31(12):1078-1084. doi: 10.1097/GME.0000000000002444.
PubMed 39579099Jeong HG, Park H. Metabolic Disorders in Menopause. Metabolites. 2022 Oct 8;12(10):954. doi: 10.3390/metabo12100954.
PubMed 36295856Ryczkowska K, Adach W, Janikowski K, Banach M, Bielecka-Dabrowa A. Menopause and women's cardiovascular health: is it really an obvious relationship? Arch Med Sci. 2022 Dec 10;19(2):458-466. doi: 10.5114/aoms/157308. eCollection 2023.
PubMed 37034510Harlow SD, Gass M, Hall JE, Lobo R, Maki P, Rebar RW, Sherman S, Sluss PM, de Villiers TJ; STRAW + 10 Collaborative Group. Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. J Clin Endocrinol Metab. 2012 Apr;97(4):1159-68. doi: 10.1210/jc.2011-3362. Epub 2012 Feb 16.
PubMed 22344196Lambrinoudaki I, Paschou SA, Armeni E, Goulis DG. The interplay between diabetes mellitus and menopause: clinical implications. Nat Rev Endocrinol. 2022 Oct;18(10):608-622. doi: 10.1038/s41574-022-00708-0. Epub 2022 Jul 7.
PubMed 35798847Fenton A. Weight, Shape, and Body Composition Changes at Menopause. J Midlife Health. 2021 Jul-Sep;12(3):187-192. doi: 10.4103/jmh.jmh_123_21. Epub 2021 Oct 16.
PubMed 34759699El Khoudary SR, Greendale G, Crawford SL, Avis NE, Brooks MM, Thurston RC, Karvonen-Gutierrez C, Waetjen LE, Matthews K. The menopause transition and women's health at midlife: a progress report from the Study of Women's Health Across the Nation (SWAN). Menopause. 2019 Oct;26(10):1213-1227. doi: 10.1097/GME.0000000000001424.
PubMed 31568098Moorman PG, Myers ER, Schildkraut JM, Iversen ES, Wang F, Warren N. Effect of hysterectomy with ovarian preservation on ovarian function. Obstet Gynecol. 2011 Dec;118(6):1271-1279. doi: 10.1097/AOG.0b013e318236fd12.
PubMed 22067716Stuenkel CA, Davis SR, Gompel A, Lumsden MA, Murad MH, Pinkerton JV, Santen RJ. Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015 Nov;100(11):3975-4011. doi: 10.1210/jc.2015-2236. Epub 2015 Oct 7.
PubMed 26444994Adamopoulos DA, Karamertzanis M, Thomopoulos A, Pappa A, Koukkou E, Nicopoulou SC. Age at menopause and prevalence of its different types in contemporary Greek women. Menopause. 2002 Nov-Dec;9(6):443-8. doi: 10.1097/00042192-200211000-00010.
PubMed 12439104Shadyab AH, Macera CA, Shaffer RA, Jain S, Gallo LC, Gass ML, Waring ME, Stefanick ML, LaCroix AZ. Ages at menarche and menopause and reproductive lifespan as predictors of exceptional longevity in women: the Women's Health Initiative. Menopause. 2017 Jan;24(1):35-44. doi: 10.1097/GME.0000000000000710.
PubMed 27465713Anto A, Basu A, Selim R, Eisingerich AB. Women's Menopausal Experiences in the UK: A Systemic Literature Review of Qualitative Studies. Health Expect. 2025 Feb;28(1):e70167. doi: 10.1111/hex.70167.
PubMed 39888228Santoro N, Roeca C, Peters BA, Neal-Perry G. The Menopause Transition: Signs, Symptoms, and Management Options. J Clin Endocrinol Metab. 2021 Jan 1;106(1):1-15. doi: 10.1210/clinem/dgaa764.
PubMed 33095879Woods NF, Mitchell ES. Symptoms during the perimenopause: prevalence, severity, trajectory, and significance in women's lives. Am J Med. 2005 Dec 19;118 Suppl 12B:14-24. doi: 10.1016/j.amjmed.2005.09.031.
PubMed 16414323