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Nutritional Supplementation on Physiological and Metabolic Markers in Females

10. juli 2026 oppdatert av: 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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Storbritannia
    • Hampshire
      • Southampton, Hampshire, Storbritannia, SO16 6YD
        • Rekruttering
        • NIHR Southampton Clinical Research Facility
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: Nutritional Supplement
Nutritional Supplement (myo-inositol, berberine, cinnamon, chromium) composed of 4 natural bioactives extracted from plants, including fruits, roots, barks, and grains.
Placebo komparator: 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.
Kosttilskudd: Placebo
Placebo: Maltodextrin

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Body mass index
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Body fat composition
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Southampton

Samarbeidspartnere

The Better Menopause

Etterforskere

  • Hovedetterforsker: Colleen S Deane, PhD, University of Southampton

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

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Studer hoveddatoer

Studiestart (Faktiske)

9. juli 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

22. mai 2026

Først innsendt som oppfylte QC-kriteriene

22. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. juli 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ERGO111652

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