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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
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 • NCT0078195012%
Increased Claudication
5%
Nausea
5%
Stroke
3%
Rest Pain in Limbs
2%
Myocardial Infarction
2%
Ulcerative Cellulitis
2%
Death
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Colorado State UniversityLead Sponsor
127 Previous Clinical Trials
38,409 Total Patients Enrolled
3 Trials studying Menopause
84 Patients Enrolled for Menopause
Kimberly Cox-york, PhDPrincipal InvestigatorColorado State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My body mass index (BMI) is between 22 and 29.9.I am a smoker.I cannot use certain hormone therapies due to health reasons.I have had breast cancer or other cancers that grow with estrogen.I have experienced unusual bleeding from my vagina.My liver tests are higher than normal but may not be permanent.I am allergic to leuprolide acetate or benzyl alcohol.My kidneys are not working well (creatinine clearance <50 mL/min).I have had a fracture from a fall at standing height or less.I am not taking any supplements for hormones, or medications for cholesterol or blood sugar.I haven't used estrogen-based birth control for over 6 months.I have had blood clots in my veins before.I am a healthy woman aged 20-40 and have not gone through menopause.I have not taken antibiotics or probiotics in the last 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: Estrogen suppression no flax
- Group 2: Estrogen suppression with flax
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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