Womens Study to Alleviate Vasomotor Symptoms (WAVS)

February 16, 2024 updated by: Physicians Committee for Responsible Medicine
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Physicians Committee for Responsible Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
Menopause Quality of Life Questionnaire (MENQOL)
Time Frame: 12 weeks
Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary Advanced Glycation End Products (AGEs)
Time Frame: 16 weeks
Explore the effectiveness of a vegan diet in reducing dietary AGEs.
16 weeks
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.
12 weeks
Ultraprocessed foods
Time Frame: 16 weeks
The consumption of ultraprocessed foods will be assessed, using the NOVA classification, at baseline and 16 weeks.
16 weeks
PDI, hPDI, uPDI
Time Frame: 16 weeks
Assess the total plant-based index (PDI), healthy PDI, and unhealthy PDI, and their relationship with weight loss.
16 weeks
Carbon Footprint
Time Frame: 16 weeks
The greenhouse gas emissions (GHGE) and cumulative energy demand (CED) will be assessed, using the database of Food Impacts on the Environment for Linking to Diets (dataFIELD) and What We Eat In America (WWEIA) database, at baseline and 16 weeks.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Physicians Committee for Responsible Medicine

Investigators

  • Principal Investigator: Neal Barnard, MD, FACC, President

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00045315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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