Clinical trial NCT04587154: Womens Study to Alleviate Vasomotor Symptoms
Official title: Womens Study to Alleviate Vasomotor Symptoms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hot Flashes
Keywords: soy
menopause
hot flash
Lead sponsor: Physicians Committee for Responsible Medicine
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Rate of Hot Flash
timeFrame: 12 weeks
measure: Menopause Quality of Life Questionnaire (MENQOL)
timeFrame: 12 weeks
Secondary outcomes:
measure: Weight Change
timeFrame: 12 weeks
measure: Dietary Advanced Glycation End Products (AGEs)
timeFrame: 16 weeks
measure: PDI, hPDI, uPDI
timeFrame: 16 weeks
measure: Ultraprocessed foods
timeFrame: 16 weeks
measure: Carbon Footprint
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Physicians Committee for Responsible Medicine
state: District of Columbia
Study officials:
affiliation: President
name: Neal Barnard, MD, FACC
role: PRINCIPAL_INVESTIGATOR
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