What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for hot flashes include hormone therapy, phytoestrogens (such as isoflavones found in soybeans), and dietary modifications. Hormone therapy can have side effects such as an increased risk of venous thromboembolism, stroke, and endometrial hyperplasia. Phytoestrogens, while generally considered safe, have shown mixed results in efficacy and may cause mild gastrointestinal disturbances. A low-fat, vegan diet including soybeans has been associated with reduced hot flashes, but the long-term adherence to such a diet can be challenging, and its side effects are not well-documented.

What prior FDA approvals exist?

The FDA has approved several treatments for hot flashes, primarily focusing on hormone therapy. These include systemic estrogens, such as oral and transdermal estradiol, which are effective in managing menopausal symptoms like hot flashes. Transdermal estrogen is particularly noted for its lower risk of venous thrombosis and stroke compared to oral estrogen. While isoflavones, a type of phytoestrogen found in soybeans, have been studied for their potential benefits in reducing menopausal symptoms, they are not currently recommended as a primary treatment for hot flashes due to inconsistent evidence. Other non-hormonal treatments, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), have also been shown to be effective in managing menopause-related symptoms.

What other types of research exist?

Promising alternatives to a low-fat, vegan diet including soybeans for treating hot flashes include low-dose estrogen plus progestin therapy for those without contraindications, and non-hormonal options such as SSRIs and gabapentin. Cognitive behavioral therapy (CBT) and lifestyle modifications like avoiding alcohol, caffeine, and spicy foods, as well as keeping the core body temperature cool, are also effective.

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Other

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

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.

Do I qualify?Apply below to find out

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.