Effect of a Natural Health Product on Urinary Estrogen Metabolites

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089049
• Other study ID #: NDI: 136987
• Secondary ID: NHPD136987
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 12, 2010
• Last updated: March 23, 2012
• Start date: August 2009
• Est. completion date: May 2010

Study information

• Verified date: March 2012
• Source: Nutrasource Diagnostics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Dietary Supplement:
• FemMED Breast Health Formula
Two capsules daily, with meals. FemMED Breast Health Formula containing lignans.

Locations

Country	Name	City	State
Canada	Nutrasource Diagnostics Inc	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Nutrasource Diagnostics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-OH Hydroxy Estrone: 16-alpha-OH Estrone	2-OHE:16a-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-a OH-estrone.	Day 0, Day 28	No
Secondary	Enterolactone	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	No