Nutritional Supplementation on Physiological and Metabolic Markers in Females

NCT07615777 | Not Yet Recruiting

• 1 other identifier: ERGO111652
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Perimenopause; menopause; metabolism; metabolomics

Outcome Measures

Primary Outcomes (1)

• Body mass index

  To compare the body mass index by measuring the weight after 12-week intervention

  At the baseline visit and at the end of 12 weeks intervention

Secondary Outcomes (7)

• Body fat composition

  At the baseline visit and at the end of the 12-week intervention

• Metabolomic profile of the plasma sample

  At the baseline visit and at the end of 12 weeks intervention

• Metabolomic profile of a urine sample

  At the baseline visit and at the end of 12 weeks intervention

• Menopause-related changes

  At the baseline visit and at the end of 12 weeks intervention

• Hand grip dynamometry

  At the baseline visit and at the end of 12 weeks intervention

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Nutritional Supplement DIETARY_SUPPLEMENT

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

Nutritional supplement

Placebo DIETARY_SUPPLEMENT

Placebo: Maltodextrin

Placebo

Eligibility Criteria

• Age: 38 Years - 55 Years
• Gender Eligibility Details: Eligibility for participation is based on biological sex, as the study investigates biological changes related to menopause.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Better Menopause: collaborator
• University of Southampton: lead

Study Sites (1)

NIHR Southampton Clinical Research Facility

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (18)

• 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.

  PMID: 38674244 BACKGROUND

• Refaei 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.

  PMID: 39579099 BACKGROUND

• Jeong HG, Park H. Metabolic Disorders in Menopause. Metabolites. 2022 Oct 8;12(10):954. doi: 10.3390/metabo12100954.

  PMID: 36295856 BACKGROUND

• Ryczkowska 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.

  PMID: 37034510 BACKGROUND

• Harlow 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.

  PMID: 22344196 BACKGROUND

• Lambrinoudaki 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.

  PMID: 35798847 BACKGROUND

• Fenton 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.

  PMID: 34759699 BACKGROUND

• El 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.

  PMID: 31568098 BACKGROUND

• Moorman 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.

  PMID: 22067716 BACKGROUND

• Stuenkel 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.

  PMID: 26444994 BACKGROUND

• Adamopoulos 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.

  PMID: 12439104 BACKGROUND

• Shadyab 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.

  PMID: 27465713 BACKGROUND

• Anto 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.

  PMID: 39888228 BACKGROUND

• Santoro 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.

  PMID: 33095879 BACKGROUND

• Woods 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.

  PMID: 16414323 BACKGROUND

• Koo S, Ahn Y, Lim JY, Cho J, Park HY. Obesity associates with vasomotor symptoms in postmenopause but with physical symptoms in perimenopause: a cross-sectional study. BMC Womens Health. 2017 Dec 8;17(1):126. doi: 10.1186/s12905-017-0487-7.

  PMID: 29216853 BACKGROUND

• Wright VJ, Schwartzman JD, Itinoche R, Wittstein J. The musculoskeletal syndrome of menopause. Climacteric. 2024 Oct;27(5):466-472. doi: 10.1080/13697137.2024.2380363. Epub 2024 Jul 30.

  PMID: 39077777 BACKGROUND

• Schoenaker DA, Jackson CA, Rowlands JV, Mishra GD. Socioeconomic position, lifestyle factors and age at natural menopause: a systematic review and meta-analyses of studies across six continents. Int J Epidemiol. 2014 Oct;43(5):1542-62. doi: 10.1093/ije/dyu094. Epub 2014 Apr 26.

  PMID: 24771324 BACKGROUND

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Colleen S Deane, PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen S Deane, PhD

CONTACT

+44 2381208664; c.s.deane@soton.ac.uk

Veronica F Santiago, PhD

CONTACT

+44 2381208664; V.F.Santiago@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Alphabetically labelled intervention/placebo, with a de-blinding envelope held by an independent researcher at the University of Southampton.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)