Effect of a Natural Health Product on Urinary Estrogen Metabolites

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nutrasource Diagnostics Inc.
ClinicalTrials.gov Identifier:
NCT01089049
First received: March 12, 2010
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Breast Cancer
Dietary Supplement: FemMED Breast Health Formula
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Nutrasource Diagnostics Inc.:

Primary Outcome Measures:
  • 2-OH Hydroxy Estrone: 16-alpha-OH Estrone [ Time Frame: Day 0, Day 28 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Enterolactone [ Time Frame: Day 0, Day 28 ] [ Designated as safety issue: No ]

    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.



Enrollment: 98
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre-Menopausal Dietary Supplement: FemMED Breast Health Formula
Two capsules daily, with meals. FemMED Breast Health Formula containing lignans.
Experimental: Post-Menopausal Dietary Supplement: FemMED Breast Health Formula
Two capsules daily, with meals. FemMED Breast Health Formula containing lignans.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089049

Locations
Canada, Ontario
Nutrasource Diagnostics Inc
Guelph, Ontario, Canada, N1G0B4
Sponsors and Collaborators
Nutrasource Diagnostics Inc.
Investigators
Principal Investigator: Maggie Laidlaw, P.hD Nutrasource Diagnostics Inc.
  More Information

No publications provided by Nutrasource Diagnostics Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nutrasource Diagnostics Inc.
ClinicalTrials.gov Identifier: NCT01089049     History of Changes
Other Study ID Numbers: NDI: 136987, NHPD136987
Study First Received: March 12, 2010
Last Updated: March 23, 2012
Health Authority: Canada: Health Canada

Keywords provided by Nutrasource Diagnostics Inc.:
Urinary Estrogen Metabolites
2-OH Estrone
16-alpha-OH Estrone
Urinary 2/16a Estrogen Metabolite Ratio

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014