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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 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

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 more

Awards & 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.

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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

Low-fat vegan diet with soybeans (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04587154 — N/A
Hot Flashes Research Study Groups: Intervention Group, Control Group
Hot Flashes Clinical Trial 2023: Low-fat vegan diet with soybeans Highlights & Side Effects. Trial Name: NCT04587154 — N/A
Low-fat vegan diet with soybeans (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04587154 — N/A
~23 spots leftby Nov 2025