Womens Study to Alleviate Vasomotor Symptoms

What this trial studies

This study tests the hypothesis that a low-fat, vegan diet including soybeans reduces the frequency and severity of menopausal hot flashes, and tests the hypothesis that total isoflavone intake is associated with the reduction in the frequency and severity of hot flashes.

Conditions in scope

• Hot Flashes

Interventions

• low-fat vegan diet with 1/2 cup soybeans daily (Other) — Weekly instructions will be given to the participants in the intervention group about following vegan diet with 1/2 cup of soybeans daily.

Who can join

Women only · Ages 40 Years to 60 Years · Accepts healthy volunteers.

Inclusion criteria

• Post-menopausal women aged 40-60 years
• English fluency
• Moderate-to-severe hot flashes experienced at least twice per day
• Started menopause within the last 10 years
• No menses in preceding 12 months
• Access to an iPhone or Android phone and willingness to install a hot-flash recording app.
• Willingness to participate in weekly classes
• Willingness to follow a low-fat vegan diet, including daily consumption of soybeans.

Exclusion criteria

• Use of hormonal medications in the preceding 2 months
• An explanation for hot flashes other than menopause (e.g., medication use, cancer treatment)
• Smoking during the past six 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)
• 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
• Use of weight-loss medications over the last 6 months or a current attempt to lose weight
• Body Mass Index \< 18.5 kg/m2

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2020-09-09
• Primary completion: 2021-07-31
• Last update posted: 2025-06-27
• First posted: 2020-10-14

Sponsor & contact

Lead sponsor: Physicians Committee for Responsible Medicine (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Rate of Hot Flash (12 weeks)
  Incidents Induced by Menopause. Hot flashes will be recorded using the MyLuna application, available in the App Store for iPhone or Android.
• Menopause Quality of Life Questionnaire (MENQOL) (12 weeks)
  Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.