Womens Study to Alleviate Vasomotor Symptoms
Completed · Not applicable
Conditions studied: Hot Flashes
In brief
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.
Key facts
- Study ID
- NCT04587154
- Run by
- Physicians Committee for Responsible Medicine
- People needed
- 80
- Starts
- 2020-09-09
- Expected to finish
- 2021-07-31
- Last updated by the study team
- 2025-06-27
Who can join
Age: 40 and older, up to 60. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Soy allergy
Where it is running
- Physicians Committee for Responsible Medicine — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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