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 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hot Flashes||Other: low-fat vegan diet with 1/2 cup soybeans daily||Early Phase 1|
|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|
|Estimated Primary Completion Date :||May 16, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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.
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|