Womens Study to Alleviate Vasomotor Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Rate of Hot Flash
Study Overview
Brief Summary
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.
Detailed Description
Women with postmenopausal hot flashes will be recruited via social media and randomly assigned to an intervention or control group. The intervention group will be asked to consume a low-fat, vegan diet including ½ cup (86g) cooked soybeans (30 g uncooked) for 12 weeks. Support will be provided by weekly meetings conducted via an Internet video conferencing platform (e.g., Zoom), along with individual counseling as needed. The control group will be asked to make no diet changes for 12 weeks but will be offered instruction in how to follow a vegan diet and about the potential role of soybeans after the 12-week point. The frequency and severity of hot flashes will be assessed before, during, and after the 12-week intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
The control group will be asked to stay on their usual diet.
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •Soy allergy
Arms & Interventions
Intervention Group
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.
Intervention: low-fat vegan diet with 1/2 cup soybeans daily (Other)
Control Group
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.
Outcomes
Primary Outcomes
Rate of Hot Flash
Time Frame: 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)
Time Frame: 12 weeks
Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)
Secondary Outcomes
- Dietary Advanced Glycation End Products (AGEs)(16 weeks)
- PDI, hPDI, uPDI(16 weeks)
- Ultraprocessed foods(16 weeks)
- Weight Change(12 weeks)
- Carbon Footprint(16 weeks)