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Dietary Supplement

Flaxseed for Menopause-Related Changes

N/A

Waitlist Available

Led By Kimberly Cox-york, PhD

Research Sponsored by Colorado State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

This trial is testing whether reducing estrogen in premenopausal women affects gut bacteria, and whether eating flaxseed affects these changes.

Who is the study for?

This trial is for healthy premenopausal women aged 20-40, with normal to slightly overweight body mass index (22-29.9 kg/m2), regular menstrual cycles, and no recent use of estrogen-based contraception or certain medications. Women who smoke, are pregnant or breastfeeding, have a history of specific health issues like low bone density or liver disease, or use hormonal contraceptives can't participate.Check my eligibility

What is being tested?

The study aims to see if lowering estrogen in premenopausal women affects their gut bacteria and whether eating flaxseed changes these effects. Participants will be given dietary flaxseed as the intervention to observe any potential modulations in their gut microbiota related to estrogen metabolism.See study design

What are the potential side effects?

While not explicitly stated for this trial, possible side effects from consuming flaxseed may include bloating, gas, abdominal discomfort, and allergic reactions. Changes in hormone levels due to interventions could also potentially cause mood swings or altered menstrual cycles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in gut microbiota diversity

Secondary outcome measures

Estrogen metabolites

Side effects data

From 2016 Phase 2 & 3 trial • 110 Patients • NCT00781950

12%

Increased Claudication

Nausea

Stroke

Rest Pain in Limbs

Myocardial Infarction

Ulcerative Cellulitis

Death

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Flaxseed

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Estrogen suppression with flaxExperimental Treatment1 Intervention

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

Group II: Estrogen suppression no flaxActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Flaxseed

2012

Completed Phase 3

~570

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Colorado State UniversityLead Sponsor

125 Previous Clinical Trials

38,329 Total Patients Enrolled

3 Trials studying Menopause

84 Patients Enrolled for Menopause

Kimberly Cox-york, PhDPrincipal InvestigatorColorado State University

Media Library

Flaxseed (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03183102 — N/A

Menopause Research Study Groups: Estrogen suppression no flax, Estrogen suppression with flax

Menopause Clinical Trial 2023: Flaxseed Highlights & Side Effects. Trial Name: NCT03183102 — N/A

Flaxseed (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03183102 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial offer enrollment opportunities for me?

"In order to qualify for inclusion, prospective patients must have gone through menopause and be between 20-40 years old. A total of 30 participants are required for this trial."

Answered by AI

Is the eligibility threshold of this clinical trial surpassing twenty years?

"This medical research project necessitates that study participants are between 20 and 40 years old. Additionally, there is a separate cohort of 4 minors and an additional group of 20 seniors enrolled in the trial."

Answered by AI

Is enrollment in this experiment accessible to the public at present?

"Clinicaltrials.gov suggests that this medical study, originally posted on October 1st 2017 and last updated on July 19th 2022, is no longer recruiting patients. However, 31 other trials are currently seeking individuals to join their studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kimberly Cox-York 2017. "The Role of the Gut Microbiota in Estrogen Metabolism and Dietary Flax as a Potential Modulator.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03183102.

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