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Effect of a Natural Health Product on Urinary Estrogen Metabolites

23. marts 2012 opdateret af: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

A Clinical Trial to Assess the Efficacy of a Supplemental Formula Targeting Breast Health in Beneficially Altering Urinary Estrogen Metabolites Levels in Both Pre- and Post-menopausal Women

The purpose of this study is to determine if a supplemental formula can beneficially alter the ratio of urinary estrogen metabolites.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The active botanical constituents in femMED Breast Health Formula contain lignans, compounds with anti-estrogenic activity, that have been shown to exert an estrogenic effect during the follicular phase [i.e. when estrogen is low] and an antiestrogenic effect in the luteal phase of a female menstrual cycle. These are plant-derived chemicals that can act as weak mimics of estrogen in the body. Overall these compounds have been found to be helpful in stabilizing the natural cyclical fluctuation of estrogen levels.

The trial will be a double-blind, placebo-controlled parallel study in which 100 subjects will be recruited to one of two arms of the study: one arm will consist of pre-menopausal women; another will consist of post-menopausal women. Each arm of the study will be carried out concurrently and in one phase, with no washout period. The placebo assignment will be randomized within each arm of the study.

Subjects in each arm of the study will follow the same protocol. Urine and blood samples will be collected from each group at both the first and last visit, and subjects will receive a month's supply of treatment or placebo at the first visit, which they will consume on a daily basis until their second lab visit 28 days later. Urine samples will be analyzed for the following estrogen metabolites: 2-OH-estrone and 16-α OH-estrone. Blood samples would be collected and assessed for levels of enterolactone. Pre and post-supplementation results will be assesses for any differences by statistical comparison.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

98

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Guelph, Ontario, Canada, N1G0B4
        • Nutrasource Diagnostics Inc

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • 18 years of age or older
  • Healthy
  • Willing to collect urine samples and to have blood drawn
  • Post-menopausal and have not taken hormone replacement therapy (HRT) in the past year (48 subjects)
  • Pre-menopausal (48 subjects)

Exclusion Criteria:

  • Diagnosed with any major illness(e.g. cancer)
  • Diabetes, thyroid disease, atypical hyperplasia, fibrocystic breast disease, family history of ovarian cancer, a history of "migraines with aura"
  • Women taking blood thinner or thyroid medication (including warfarin)
  • Known allergy to any of the any of the study ingredients
  • Pregnancy or lactation
  • Regular consumption in the previous 3 months of any other natural health products (NHPs) or pharmaceutical containing ingredients with a similar effect on estrogen metabolism as those included in the femMED Breast Health treatment
  • Family history of breast cancer risk
  • Post-menopausal women on HRT
  • Pre-menopausal women taking hormonal contraceptives (oral contraceptives, the patch etc.)
  • All other forms of estrogen, progesterone and/or androgens (i.e. testosterone therapy)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Pre-Menopausal
Kosttilskud: FemMED Breast Health Formula
Two capsules daily, with meals. FemMED Breast Health Formula containing lignans.
Eksperimentel: Post-Menopausal
Kosttilskud: FemMED Breast Health Formula
Two capsules daily, with meals. FemMED Breast Health Formula containing lignans.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
2-OH Hydroxy Estrone: 16-alpha-OH Estrone
Tidsramme: Day 0, Day 28

2-OHE:16α-OHE1 (2:16 ratio) - 2:16 ratios less than 2.0 indicate increasing long-term risk for breast, cervical, and other estrogen sensitive cancers.

Urine samples will be analyzed for the following estrogen metabolites: 2-OH-estrone and 16-α OH-estrone.
Day 0, Day 28

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Enterolactone
Tidsramme: Day 0, Day 28

Enterolactone is a lignan formed by the action of intestinal bacteria on lignan precursors found in plants. For the purpose of this study, enterolactone will serve as an indicator of compliance/dietary intake of lignans.

Blood samples would be collected and assessed for levels of enterolactone.
Day 0, Day 28

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Efterforskere

  • Ledende efterforsker: Maggie Laidlaw, P.hD, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2009

Primær færdiggørelse (Faktiske)

1. april 2010

Studieafslutning (Faktiske)

1. maj 2010

Datoer for studieregistrering

Først indsendt

12. marts 2010

Først indsendt, der opfyldte QC-kriterier

17. marts 2010

Først opslået (Skøn)

18. marts 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. marts 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. marts 2012

Sidst verificeret

1. marts 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • NDI: 136987
  • NHPD136987 (Anden identifikator: Natural Health Products Directorate, Health Canada)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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