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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
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine

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.

Condition or disease Intervention/treatment Phase
Hot Flashes Other: low-fat vegan diet with 1/2 cup soybeans daily Early Phase 1

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 162 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
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: Single (Investigator)
Masking Description: The control group will be asked to stay on their usual diet.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. Menopause Quality of Life Questionnaire (MENQOL) [ Time Frame: 12 weeks ]
    Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. Post-menopausal women aged 40-60 years
  2. English fluency
  3. Moderate-to-severe hot flashes experienced at least twice per day
  4. Started menopause within the last 10 years
  5. No menses in preceding 12 months
  6. Access to an iPhone or Android phone and willingness to install a hot-flash recording app.
  7. Willingness to participate in weekly classes
  8. Willingness to follow a low-fat vegan diet, including daily consumption of soybeans.

Exclusion Criteria:

  1. Use of hormonal medications in the preceding 2 months
  2. An explanation for hot flashes other than menopause (e.g., medication use, cancer treatment)
  3. Smoking during the past six months
  4. 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)
  5. 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
  6. Use of recreational drugs in the past 6 months
  7. Use of weight-loss medications over the last 6 months or a current attempt to lose weight
  8. Body Mass Index < 18.5 kg/m2
  9. Soy allergy

Information from the National Library of Medicine

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


Locations
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United States, District of Columbia
Physicians Committee for Responsible Medicine
Washington, District of Columbia, United States, 20016
Sponsors and Collaborators
Physicians Committee for Responsible Medicine
Investigators
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Principal Investigator: Neal Barnard, MD, FACC President
Publications:
American College of Obstetrics and Gynecology. Response to Women's Health Initiative Study Results by The American College of Obstetricians and Gynecologists, August 9, 2002. Internet: http://www.losolivos-obgyn.com/info/gynecology/menopause/acog_whi_2002.pdf

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Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT04587154    
Other Study ID Numbers: Pro00045315
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Physicians Committee for Responsible Medicine:
soy
menopause
hot flash
Additional relevant MeSH terms:
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Hot Flashes