Clinical trial NCT03183102: The Role of the Gut Microbiota in Estrogen Metabolism and Dietary Flax as a Potential Modulator.
Official title: The Role of the Gut Microbiota in Estrogen Metabolism and Dietary Flax as a Potential Modulator.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in gut microbiota diversity
timeFrame: 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:
measure: Estrogen metabolites
timeFrame: 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
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Kimberly Cox-york, PhD
role: PRINCIPAL_INVESTIGATOR
References: