Womens Study to Alleviate Vasomotor Symptoms (WAVS)
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|ClinicalTrials.gov Identifier: NCT04587154|
Recruitment Status : Active, not recruiting
First Posted : October 14, 2020
Last Update Posted : March 9, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Hot Flashes||Other: low-fat vegan diet with 1/2 cup soybeans daily||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 Description:||The control group will be asked to stay on their usual diet.|
|Official Title:||Womens Study to Alleviate Vasomotor Symptoms|
|Actual Study Start Date :||September 9, 2020|
|Actual Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: 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.
Other: low-fat vegan diet with 1/2 cup soybeans daily
Weekly instructions will be given to the participants in the intervention group about following vegan diet with 1/2 cup of soybeans daily.
Other Name: Vegan diet
No Intervention: 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.
- 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)
- Weight Change [ Time Frame: 12 weeks ]Body weight changes, which will be measured weekly using a Renfro scale sent out to participants in both groups.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||40 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||This study only seeks people who have had their last period, thus excluding males.|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587154
|United States, District of Columbia|
|Physicians Committee for Responsible Medicine|
|Washington, District of Columbia, United States, 20016|
|Principal Investigator:||Neal Barnard, MD, FACC||President|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Physicians Committee for Responsible Medicine|
|Other Study ID Numbers:||
|First Posted:||October 14, 2020 Key Record Dates|
|Last Update Posted:||March 9, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|