Nutritional Supplementation on Physiological and Metabolic Markers in Females

Официальное название

A Pilot Study Investigating the Effects of a Nutritional Supplement on Physiological and Metabolic Markers in 38-55-year-old Females

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Body mass index [Срок оценки: At the baseline visit and at the end of 12 weeks intervention]

Вторичные конечные точки (7)

• Body fat composition [Срок оценки: At the baseline visit and at the end of the 12-week intervention]
• Metabolomic profile of the plasma sample [Срок оценки: At the baseline visit and at the end of 12 weeks intervention]
• Metabolomic profile of a urine sample [Срок оценки: At the baseline visit and at the end of 12 weeks intervention]
• Menopause-related changes [Срок оценки: At the baseline visit and at the end of 12 weeks intervention]
• Hand grip dynamometry [Срок оценки: At the baseline visit and at the end of 12 weeks intervention]
• Portable strength tracking system [Срок оценки: At the baseline visit and at the end of the 12-week intervention]
• Transcriptomic profile of blood sample [Срок оценки: At the baseline visit and at the end of the 12-week intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Великобритания · 1 центр

• NIHR Southampton Clinical Research Facility — Southampton

Публикации

• 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
• 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
• Jeong HG, Park H. Metabolic Disorders in Menopause. Metabolites. 2022 Oct 8;12(10):954. doi: 10.3390/metabo12100954. PMID 36295856
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07615777 · ERGO111652

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗