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 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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
Maggie Laidlaw, P.hD
Nutrasource Diagnostics Inc.
Canada: Health Canada