A randomized, double-blind, placebo-controlled, cross-over trial to evaluate the effect of EstroSense® on 2-hydroxyestrone:16α-hydroxyestrone ratio in premenopausal women.
J Complement Integr Med
; 20(1): 199-206, 2023 Mar 01.
Article
in En
| MEDLINE
| ID: mdl-36201753
ABSTRACT
OBJECTIVES:
Some estrogen metabolites are associated with increased breast cancer risk, while others are protective. Research efforts have focused on modifiable factors, including bioactive compounds found in food or supplements, promoting estrogen profiles with anti-cancer properties. EstroSense® is a nutraceutical product with bioactive compounds, including Indole-3-carbinol and green-tea catechins, which may favourably affect estrogen profiles. This study was conducted to determine if EstroSense use, compared to placebo, promotes a higher urinary 2-hydroxyestrone16α-hydroxyestrone ratio (2-OHE116α-OHE1), a biomarker associated with a lowered risk of breast cancer.METHODS:
A total of 148 premenopausal women were recruited from British Columbia, Canada to participate in a randomized, double-blind, cross-over, multicentre, placebo-controlled study in which women were randomized to a treatment sequence that consisted of either EstroSense®, followed by placebo or vice-versa. The women were instructed to consume three capsules per day of EstroSense® or the placebo for three menstrual cycles (â¼12 weeks). The primary outcome was the measurement of 2-OHE116α-OHE1 in casual samples at baseline and after each treatment phase.RESULTS:
After 12 weeks of intervention, the mean (95% CI) urinary 2-OHE116α-OHE1 was 4.55 (2.69, 6.42) (p<0.001) higher following EstroSense than placebo adjusted for baseline values.CONCLUSIONS:
EstroSense use led to markedly higher urinary 2-OHE116α-OHE1 than the placebo, a biomarker associated with a lower risk of breast cancer. REGISTRATION http//clinicaltrials.gov (NCT02385916).Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Breast Neoplasms
/
Hydroxyestrones
Type of study:
Clinical_trials
Limits:
Female
/
Humans
Language:
En
Journal:
J Complement Integr Med
Year:
2023
Document type:
Article
Affiliation country:
Canada
Publication country:
ALEMANHA
/
ALEMANIA
/
DE
/
DEUSTCHLAND
/
GERMANY