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Womens Study to Alleviate Vasomotor Symptoms (WAVS)

Primary Purpose

Hot Flashes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
low-fat vegan diet with 1/2 cup soybeans daily
Sponsored by
Physicians Committee for Responsible Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring soy, menopause, hot flash

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Physicians Committee for Responsible Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Menopause Quality of Life Questionnaire (MENQOL)
Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)

Secondary Outcome Measures

Weight Change
Body weight changes, which will be measured weekly using a Renfro scale sent out to participants in both groups.

Full Information

First Posted
October 6, 2020
Last Updated
March 7, 2023
Sponsor
Physicians Committee for Responsible Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04587154
Brief Title
Womens Study to Alleviate Vasomotor Symptoms
Acronym
WAVS
Official Title
Womens Study to Alleviate Vasomotor Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physicians Committee for Responsible Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
Keywords
soy, menopause, hot flash

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
The control group will be asked to stay on their usual diet.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
low-fat vegan diet with 1/2 cup soybeans daily
Other Intervention Name(s)
Vegan diet
Intervention Description
Weekly instructions will be given to the participants in the intervention group about following vegan diet with 1/2 cup of soybeans daily.
Primary Outcome Measure Information:
Title
Rate of Hot Flash
Description
Incidents Induced by Menopause. Hot flashes will be recorded using the MyLuna application, available in the App Store for iPhone or Android.
Time Frame
12 weeks
Title
Menopause Quality of Life Questionnaire (MENQOL)
Description
Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Weight Change
Description
Body weight changes, which will be measured weekly using a Renfro scale sent out to participants in both groups.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study only seeks people who have had their last period, thus excluding males.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Barnard, MD, FACC
Organizational Affiliation
President
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physicians Committee for Responsible Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Womens Study to Alleviate Vasomotor Symptoms

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