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

NCT03183102 | Completed

• 1 other identifier: 16-6978H
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Estrogen metabolites

  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

Study Arms (2)

Estrogen suppression no flax

NO INTERVENTION

Control subjects will not consume flaxseed, but will receive GnRH suppression

Estrogen suppression with flax

EXPERIMENTAL

Flax subjects will consume flaxseed for 2 months in addition to GnRH suppression

Dietary Supplement: Flaxseed

Interventions

Flaxseed DIETARY_SUPPLEMENT

2 months of dietary flaxseed supplementation

Estrogen suppression with flax

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

MeSH Terms

Interventions

Linseed Oil

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Kimberly Cox-york, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Biological samples will be masked for endpoint analysis
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 9, 2017
• Study Start: October 1, 2017
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)