Womens Study to Alleviate Vasomotor Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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Womens Study to Alleviate Vasomotor Symptoms

Conditions
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Hot Flashes

Intervention / Treatment
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* Other: low-fat vegan diet with 1/2 cup soybeans daily


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One arm, the intervention group, has been randomly assigned to be on a low-fat vegan diet while consuming 1/2 cup of cooked soybeans each day. The other arm, the control group, will maintain their pre-study diet for the duration of the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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. | Other: low-fat vegan diet with 1/2 cup soybeans daily<br>* Weekly instructions will be given to the participants in the intervention group about following vegan diet with 1/2 cup of soybeans daily.<br>* Other names: Vegan diet;|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change | Body weight changes, which will be measured weekly using a Renfro scale sent out to participants in both groups. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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soy, menopause, hot flash