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Vegan Diet + Soybeans for Hot Flashes (WAVS Trial)
N/A
Waitlist Available
Led By Neal Barnard, MD, FACC
Research Sponsored by Physicians Committee for Responsible Medicine
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 16 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a low-fat, vegan diet with soybeans can reduce menopausal hot flashes. Women experiencing these symptoms will follow this diet for a few months. The soybeans might help lessen hot flashes by acting like estrogen. Soy has been studied for its potential to reduce menopausal hot flashes, with varying degrees of success reported in different studies.
Who is the study for?
This trial is for post-menopausal women aged 40-60 who experience moderate-to-severe hot flashes at least twice daily. Participants must be fluent in English, have not had a period in the last year, and be willing to follow a low-fat vegan diet with soybeans. They need access to a smartphone for an app. Women who smoke, have eating disorders, soy allergies, or use certain medications are excluded.
What is being tested?
The study is examining if a low-fat vegan diet that includes half a cup of soybeans daily can reduce the frequency and severity of menopausal hot flashes. It also looks into whether intake of total isoflavones from this diet correlates with any observed benefits.
What are the potential side effects?
Potential side effects may include digestive changes due to dietary adjustment such as bloating or gas, possible allergic reactions to soy for those sensitive (though they are excluded), and nutritional deficiencies if the diet isn't well-balanced.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Menopause Quality of Life Questionnaire (MENQOL)
Rate of Hot Flash
Secondary study objectives
Carbon Footprint
Dietary Advanced Glycation End Products (AGEs)
PDI, hPDI, uPDI
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
This arm will follow a low-fat vegan diet in addition to 1/2 a cup of cooked soybeans each day for the duration of the study. They will also weigh themselves each week, and report weight and hot flash frequency/severity weekly.
Group II: Control GroupActive Control1 Intervention
This arm will not change their diet for the duration of the study. They will also weigh themselves each week and report weight and hot flash frequency/severity weekly.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Isoflavones, found in soybeans, are phytoestrogens that mimic estrogen by binding to estrogen receptors, potentially alleviating hot flashes by exerting mild estrogenic effects. This is particularly beneficial for postmenopausal women with declining estrogen levels.
Hormone therapy, involving systemic estrogen or a combination of estrogen and progestin, replenishes estrogen levels to reduce hot flashes. Understanding these mechanisms helps patients make informed decisions about their treatment options, balancing efficacy and potential side effects.
Phytoestrogens in clinical practice: a review of the literature.Isoflavone-rich or isoflavone-poor soy protein does not reduce menopausal symptoms during 24 weeks of treatment.
Phytoestrogens in clinical practice: a review of the literature.Isoflavone-rich or isoflavone-poor soy protein does not reduce menopausal symptoms during 24 weeks of treatment.
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Who is running the clinical trial?
Physicians Committee for Responsible MedicineLead Sponsor
29 Previous Clinical Trials
2,505 Total Patients Enrolled
Neal Barnard, MD, FACCPrincipal InvestigatorPresident
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience hot flashes at least twice a day.I am a woman aged 40-60 and have gone through menopause.I have not used weight-loss medications or tried to lose weight in the last 6 months.I have used hormonal medications in the last 2 months.I am willing to attend weekly classes.I started menopause within the last 10 years.My hot flashes are due to reasons other than menopause.I have a smartphone and am willing to use an app to track hot flashes.I have a smartphone and am willing to use an app to track hot flashes.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
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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