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

Colorado State University (CSU)

Status

Completed

Conditions

Menopause

Treatments

Dietary Supplement: Flaxseed

Study type

Interventional

Funder types

Other

Identifiers

NCT03183102

16-6978H

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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