Vegan Diet + Soybeans for Hot Flashes

(WAVS Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Physicians Committee for Responsible Medicine

Must not be taking: Hormonal medications

Disqualifiers: Smoking, Eating disorder, Alcohol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Neal Barnard, MD, FACC

Principal Investigator

President

Eligibility Criteria

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.

Inclusion Criteria

I experience hot flashes at least twice a day.

I am a woman aged 40-60 and have gone through menopause.

No menses in preceding 12 months

Exclusion Criteria

Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use

Use of recreational drugs in the past 6 months

History of an eating disorder or evidence of a current eating disorder (as determined by an eating disorder diagnosis, the discretion of a qualified medical professional, or an Eating Attitudes Test-26 score >20)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a low-fat vegan diet including soybeans for 12 weeks, with weekly virtual meetings and individual counseling as needed

12 weeks

12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of dietary impacts and hot flash frequency

4 weeks

Treatment Details

Interventions

• Low-fat vegan diet with soybeans

Trial Overview 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.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

Physicians Committee for Responsible Medicine

Lead Sponsor

Trials

30

Recruited

2,600+