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

Completed · Not applicable

Conditions studied: Menopause

In brief

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.

Key facts

Study ID

NCT03183102

Run by

Colorado State University

People needed

30

Starts

2017-10-01

Expected to finish

2022-12-30

Last updated by the study team

2024-07-31

Who can join

Age: 20 and older, up to 40. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• Colorado State University — Fort Collins, Colorado, United States

Full record on ClinicalTrials.gov

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