Womens Study to Alleviate Vasomotor Symptoms

Not Applicable

Active, not recruiting

• Conditions: Hot Flashes
• Interventions: Other: low-fat vegan diet with 1/2 cup soybeans daily

• Registration Number: NCT04587154
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-09-09
• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-14
• Primary Completion: 2021-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	low-fat vegan diet with 1/2 cup soybeans daily	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.

Primary Outcome Measures

Name	Time	Method
Rate of Hot Flash	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)	12 weeks	Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)

Secondary Outcome Measures

Name	Time	Method
Dietary Advanced Glycation End Products (AGEs)	16 weeks	Explore the effectiveness of a vegan diet in reducing dietary AGEs.
PDI, hPDI, uPDI	16 weeks	Assess the total plant-based index (PDI), healthy PDI, and unhealthy PDI, and their relationship with weight loss.
Ultraprocessed foods	16 weeks	The consumption of ultraprocessed foods will be assessed, using the NOVA classification, at baseline and 16 weeks.
Weight Change	12 weeks	Body weight changes, which will be measured weekly using a Renfro scale sent out to participants in both groups.
Carbon Footprint	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.

Trial Locations

Locations (1)

Physicians Committee for Responsible Medicine; 🇺🇸 Washington, District of Columbia, United States