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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
Moderate-to-severe hot flashes experienced at least twice per day
Post-menopausal women aged 40-60 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

WAVS Trial Summary

This trial tests if a vegan diet with soybeans can help reduce the frequency and severity of menopausal hot flashes, and if isoflavone intake is associated with the reduction in the frequency and severity of hot flashes.

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.Check my eligibility
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.See study design
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.

WAVS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience hot flashes at least twice a day.
Select...
I am a woman aged 40-60 and have gone through menopause.

WAVS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Menopause Quality of Life Questionnaire (MENQOL)
Rate of Hot Flash
Secondary outcome measures
Carbon Footprint
Dietary Advanced Glycation End Products (AGEs)
PDI, hPDI, uPDI
+2 more

WAVS 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.

Find a Location

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

Frequently Asked Questions

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

Is the research team actively searching for participants to join this clinical trial?

"As per clinicaltrials.gov, this medical trial is no longer seeking candidates as it was first posted on September 9th 2020 and last updated April 25th 2022. Fortunately, there are 29 other trials open to new patients at the present moment."

Answered by AI

Are younger adults aged under 25 years admissible to participate in this research?

"This trial has outlined a minimum and maximum age threshold for participation: 40 to 60 years old respectively."

Answered by AI

Could I be accepted as a participant in this clinical research?

"To meet the eligibility criteria for this clinical trial, potential participants must experience hot flashes and fall between 40 to 60 years old. The study is currently looking to enroll 120 individuals in total."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~27 spots leftby Mar 2025