The Role of the Gut Microbiota in Estrogen Metabolism and Dietary Flax as a Potential Modulator.

Menopause Clinical Trial

Official title:

The Role of the Gut Microbiota in Estrogen Metabolism and Dietary Flax as a Potential Modulator.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03183102
• Other study ID #: 16-6978H
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: July 30, 2024

Study information

• Verified date: February 2024
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to determine if suppressing estrogen in premenopausal women results in changes in gut microbiota and if dietary flaxseed modulates these changes.

Description:

This pilot study will begin to address whether gut microbiota change with estrogen suppression. Specifically, the investigators will test whether gut microbial diversity and abundance change in response to estrogen suppression and consumption of dietary flaxseed. To test this possibility the investigators will recruit premenopausal women (age 20-40 years old)and collect fecal samples before and after 1 month of estrogen suppression with GnRH agonist. The investigators will analyze the gut microbiota in response to estrogen loss and whether this differs with the consumption of flaxseed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 30, 2024
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• healthy premenopausal women (20-40 years)

• normal to overweight (22-29.9 kg/m2)

• normally menstruating (25-35 day cycles)

• not have used estrogen-based contraception for >6 months.

• sedentary to moderately active (exercise =120 min week-1)

• must not be taking phytoestrogenic dietary supplements, or lipid- or glucose- lowering medications.

Exclusion Criteria:

• smoking

• pregnancy or breastfeeding

• Hormonal contraceptive use (past 6 mo.)

• Women with contraindications to GnRHAG:

• History of fragility fracture

• Low BMD (i.e., proximal femur or lumbar spine z scores < -2.0)

• Abnormal vaginal bleeding

• History of breast cancer or other estrogen-dependent neoplasms

• History of venous thromboembolic events

• Hypersensitivity to leuprolide acetate or benzyl alcohol (the vehicle for injection of leuprolide acetate)

• Evidence for depressive symptoms (Score = 18 on the Beck Depression Inventory, BDI)

• Moderate or severe renal impairment defined as a calculated creatinine clearance <50 mL/min based on the equation of Cockcroft and Gault91

• Chronic hepatobiliary disease, conservatively defined as liver function tests (AST, ALT, alkaline phosphatase, Total Bilirubin) >1.5 times the upper limit of normal (if such values are obtained on initial screening and thought to be transient in nature, repeated testing will be allowed)

• antibiotic or probiotic use within 2 months of sample collection

Related Conditions & MeSH terms

• Menopause

Intervention

Dietary Supplement:
• Flaxseed
2 months of dietary flaxseed supplementation

Locations

Country	Name	City	State
United States	Colorado State University	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gut microbiota diversity	16s rRNA sequencing--Illumina MiSeq	At baseline (day 0) and 30 days after estrogen suppression, with and without dietary flaxseed 30 days before estrogen suppression and during the 30 days of estrogen suppression
Secondary	Estrogen metabolites	estrogen metabolites (parent:metabolite ratio) in urine and plasma	At baseline (day 0) and 30 days after estrogen suppression, with and without dietary flaxseed 30 days before estrogen suppression and during the 30 days of estrogen suppression