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Nutritional Supplementation on Physiological and Metabolic Markers in Females

2026年7月10日 更新者:University of Southampton

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.

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

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

80

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Hampshire
      • Southampton、Hampshire、イギリス、SO16 6YD
        • 募集
        • NIHR Southampton Clinical Research Facility
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的:Nutritional supplement

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.
Nutritional Supplement (myo-inositol, berberine, cinnamon, chromium) composed of 4 natural bioactives extracted from plants, including fruits, roots, barks, and grains.
プラセボコンパレーター:Placebo

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.
Placebo: Maltodextrin

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Body mass index
時間枠: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
At the baseline visit and at the end of 12 weeks intervention

二次結果の測定

結果測定
メジャーの説明
時間枠
Body fat composition
時間枠: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
At the baseline visit and at the end of the 12-week intervention
Metabolomic profile of the plasma sample
時間枠: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
At the baseline visit and at the end of 12 weeks intervention
Metabolomic profile of a urine sample
時間枠: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.
At the baseline visit and at the end of 12 weeks intervention
Menopause-related changes
時間枠: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.
At the baseline visit and at the end of 12 weeks intervention
Hand grip dynamometry
時間枠: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
At the baseline visit and at the end of 12 weeks intervention
Portable strength tracking system
時間枠: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
At the baseline visit and at the end of the 12-week intervention
Transcriptomic profile of blood sample
時間枠: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
At the baseline visit and at the end of the 12-week intervention

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Colleen S Deane, PhD、University of Southampton

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月9日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2026年12月1日

試験登録日

最初に提出

2026年5月22日

QC基準を満たした最初の提出物

2026年5月22日

最初の投稿 (実際)

2026年5月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月13日

QC基準を満たした最後の更新が送信されました

2026年7月10日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • ERGO111652

個々の参加者データ (IPD) の計画

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いいえ

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いいえ

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