Effect of a Natural Health Product on Urinary Estrogen Metabolites

NCT01089049 | Completed Phase 1

• 2 other identifiers: NDI: 136987NHPD136987
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Urinary Estrogen Metabolites; 2-OH Estrone; 16-alpha-OH Estrone; Urinary 2/16a Estrogen Metabolite Ratio

Outcome Measures

Primary Outcomes (1)

• 2-OH Hydroxy Estrone: 16-alpha-OH Estrone

  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

Secondary Outcomes (1)

• Enterolactone

  Day 0, Day 28

Study Arms (2)

Pre-Menopausal

EXPERIMENTAL

Dietary Supplement: FemMED Breast Health Formula

Post-Menopausal

EXPERIMENTAL

Dietary Supplement: FemMED Breast Health Formula

Interventions

FemMED Breast Health Formula DIETARY_SUPPLEMENT

Two capsules daily, with meals. FemMED Breast Health Formula containing lignans.

Post-Menopausal; Pre-Menopausal

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: lead

Study Sites (1)

Nutrasource Diagnostics Inc

Guelph, Ontario, N1G0B4, Canada

Location

Related Publications (1)

• Laidlaw M, Cockerline CA, Sepkovic DW. Effects of a breast-health herbal formula supplement on estrogen metabolism in pre- and post-menopausal women not taking hormonal contraceptives or supplements: a randomized controlled trial. Breast Cancer (Auckl). 2010 Dec 16;4:85-95. doi: 10.4137/BCBCR.S6505.

  PMID: 21234288 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Maggie Laidlaw, P.hD

  Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 18, 2010
• Study Start: August 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

CA (1)