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A randomized, double-blind, placebo-controlled, cross-over trial to evaluate the effect of EstroSense® on 2-hydroxyestrone:16α-hydroxyestrone ratio in premenopausal women

  • Tim Green , Janet See , Marita Schauch , Julie Reil , Melissa Glover , Jennifer Brix , Adella Gerry , Kathy Li , Mark Newman , Roland J. Gahler and Simon Wood EMAIL logo
Published/Copyright: October 6, 2022
Journal of Complementary and Integrative Medicine
From the journal Journal of Complementary and Integrative Medicine Volume 20 Issue 1

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-hydroxyestrone:16α-hydroxyestrone ratio (2-OHE1:16α-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 (∼12 weeks). The primary outcome was the measurement of 2-OHE1:16α-OHE1 in casual samples at baseline and after each treatment phase.

Results

After 12 weeks of intervention, the mean (95% CI) urinary 2-OHE1:16α-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-OHE1:16α-OHE1 than the placebo, a biomarker associated with a lower risk of breast cancer.

Registration

http://clinicaltrials.gov (NCT02385916).

Keywords: 2-hydroxyestrone:16α-hydroxyestrone ratio; breast cancer; cancer biomarkers; EstroSense; natural health products; urinary estrogens
Corresponding author: Simon Wood, PhD, Adjunct Professor, Food, Nutrition and Health, University of British Columbia, Victoria, BC, Canada; and School of Public Health, Faculty of Health Sciences, Curtin University, WA, Australia, Phone: +1 250 721 3024, E-mail:

Funding source: Preferred Nutrition Incorporated, ON, Canada and Assured Natural Distribution Inc, BC, Canada

  1. Research funding: This study was funded by Preferred Nutrition Incorporated, ON, Canada and Assured Natural Distribution Inc, BC, Canada.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Related to this paper TG, MS, JR, JB and SW receive consulting fees from The Factors Group of Companies. JS is an employee of The Factors Group of Companies. MS, MG, JB and AG received funds to conduct the study at their sites. MN is the owner of Precision Analytical Inc, the company that measured the urinary estrogen metabolites. RJG is the owner of the Factors Group of Companies. KL reports no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: The study was approved by the University of British Columbia Human Research Ethics Committee (H15-00279). The trial was registered at clinicaltrials.gov (NCT02385916).

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/jcim-2022-0301).

Received: 2022-06-13
Accepted: 2022-09-14
Published Online: 2022-10-06

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/jcim-2022-0301
Keywords for this article
2-hydroxyestrone:16α-hydroxyestrone ratio; breast cancer; cancer biomarkers; EstroSense; natural health products; urinary estrogens

Articles in the same Issue

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  2. Reviews
  3. Does acupuncture improve sexual dysfunction? A systematic review
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  5. Phytochemistry and pharmacology of Celastrus paniculatus Wild.: a nootropic drug
  6. Low back pain patients’ perceived effectiveness of utilizing complementary and alternative medicine: a systematic review of qualitative studies
  7. Efficacy and tolerability of Lavandula angustifolia in treating patients with the diagnosis of depression: a systematic review of randomized controlled trials
  8. Research Articles
  9. Psychobiotic interventions attenuate chronic alcohol use-mediated exacerbation of posttraumatic stress disorder in rats: the role of gut-liver axis response
  10. Evaluation of the toxicity of crude aqueous Pleurotus tuber-regium (Fr.) Singer extract in mice
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  13. Antimicrobial, anti-adhesion, anti-biofilm properties of goji berry (Lycium barbarum) against periodontal bacteria: potential benefits for periodontal diseases
  14. Method development and validation for quantification of six bioactive compounds (andrographolide, columbin, piperine, gallic, paracoumaric and oleanolic acids) by HPTLC
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  16. Naturopathic knowledge and approaches to managing endometriosis: a cross-sectional survey of naturopaths with experience in endometriosis care
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  18. Trends in the St. John’s wort (Hypericum perforatum) research literature: a bibliometric analysis
  19. Use and perception of complementary and alternative medicine among Iranian psychologists
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