NIHR Southampton Clinical Research Facility
Southampton, Hampshire, SO16 6YD, United Kingdom
Location status: Recruiting
NCT Number: NCT07615777
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
Interested in participating?
Request Info38 year–55 year
Female
Interventional
Not applicable
Southampton, Hampshire, SO16 6YD, United Kingdom
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nutritional Supplement (myo-inositol, berberine, cinnamon, chromium) composed of 4 natural bioactives extracted from plants, including fruits, roots, barks, and grains.
Placebo: Maltodextrin
Time frame: At the baseline visit and at the end of 12 weeks intervention
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 the 12-week intervention
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 12 weeks intervention
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
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
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
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 the 12-week intervention
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
To compare the effect of a 12-week nutritional intervention versus placebo on the blood transcriptome
Contact information is provided by the study sponsor or research team.
Colleen S Deane, PhD
CONTACT
Veronica F Santiago, PhD
CONTACT
University of Southampton
Other
A Pilot Study Investigating the Effects of a Nutritional Supplement on Physiological and Metabolic Markers in 38-55-year-old Females
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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