Vegan Diet + Soybeans for Hot Flashes

(WAVS Trial)

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a low-fat, vegan diet with soybeans can reduce the frequency and severity of hot flashes during menopause. Participants will either follow the diet or maintain their usual eating habits to determine which approach is more effective. Women experiencing moderate-to-severe hot flashes at least twice daily since menopause began within the last decade may be suitable candidates. This study could provide new insights into managing menopause symptoms through dietary changes. As an unphased trial, participants contribute to groundbreaking research that may lead to new dietary recommendations for menopause management.

Will I have to stop taking my current medications?

The trial requires that you have not used hormonal medications in the last 2 months. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that a low-fat vegan diet with soybeans is likely to be safe?

Research has shown that a low-fat, vegan diet including soybeans is generally safe and can help reduce hot flashes. Studies have found that this diet can decrease the frequency and severity of hot flashes, with some individuals experiencing up to a 92% reduction in severe symptoms. Additionally, this diet often results in healthy weight loss, enhancing overall well-being.

No major reports of negative effects have emerged from following this diet. Since it includes common foods like soybeans, most people tolerate it well. However, as with any dietary change, consulting a healthcare provider before starting is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the low-fat vegan diet with soybeans for hot flashes because it offers a natural, dietary approach that differs from hormone replacement therapies typically used to manage symptoms. This treatment leverages the potential benefits of a plant-based diet and soybeans, which are rich in phytoestrogens, to possibly reduce the frequency and severity of hot flashes. Unlike standard options that involve medication, this approach is non-invasive and may offer additional health benefits such as weight management. This unique combination makes it an appealing option for those seeking a more holistic and lifestyle-oriented way to manage hot flashes.

What evidence suggests that a low-fat vegan diet with soybeans might be an effective treatment for hot flashes?

This trial will evaluate the effects of a low-fat vegan diet with soybeans on menopausal hot flashes. Research has shown that such a diet can greatly reduce the frequency and severity of hot flashes, with studies finding a 92% drop in severe hot flashes. Participants in the intervention group will follow this diet, which includes soybeans containing natural plant compounds called isoflavones, believed to be crucial for these benefits. This diet is also associated with healthy weight loss, which might further help reduce hot flashes. Overall, evidence suggests that this way of eating could effectively manage hot flashes during menopause. ^{2 3 6 7 8}

Who Is on the Research Team?

Neal Barnard, MD, FACC

Principal Investigator

President

Are You a Good Fit for This Trial?

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.

English fluency

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. menopause.org menopause.org/press-releases/hot-flashes-may-be-less-bothersome-for-vegans

Hot Flashes May Be Less Bothersome for Vegans Research has shown that a low-fat vegan diet—specifically one supplemented with soybeans—can reduce body weight and hot flashes. Studies have ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0378512225004694

Isoflavones and changes in body weight and severe hot ... Conclusions. These findings suggest that the mechanisms by which a low-fat vegan diet supplemented with soybeans reduces the frequency of severe hot flashes ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39580383/

Diet quality, body weight, and postmenopausal hot flashes A low-fat vegan diet, supplemented with soybeans, has been shown effective in reducing postmenopausal hot flashes.

4. journals.lww.com journals.lww.com/menopausejournal/fulltext/2025/09000/processed_foods_in_the_context_of_a_vegan_diet,.12.aspx

Processed foods in the context of a vegan diet, and ... A low-fat vegan diet that included daily consumption of soybeans led to a 92% reduction in severe hot flashes and a 73% reduction in dietary AGEs. The ...

5. contemporaryobgyn.net contemporaryobgyn.net/view/vegan-diet-linked-to-reduced-hot-flashes-and-body-weight

Vegan diet linked to reduced hot flashes and body weight A low-fat, soy-rich vegan diet significantly decreases severe hot flashes and supports healthy weight loss, according to new research.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8462449/

The Women's Study for the Alleviation of Vasomotor ... The combination of a low-fat, vegan diet and whole soybeans was associated with reduced frequency and severity of hot flashes and improved quality of life.

7. journals.lww.com journals.lww.com/menopausejournal/fulltext/2023/01000/a_dietary_intervention_for_vasomotor_symptoms_of.12.aspx

A dietary intervention for vasomotor symptoms of menopause The possibility that a low-fat, plant-based diet with daily soybeans might be more potent against vasomotor symptoms comes from the fact that such diets are ...

8. pcrm.org pcrm.org/news/news-releases/opting-plant-based-foods-instead-animal-products-leads-weight-loss-reduction-hot

Opting for Plant-Based Foods Instead of Animal Products ... ... fat vegan diet, including a half cup cooked soybeans a day, or to ... Severe hot flashes were reduced by 92% in the vegan group and did ...