Hot Flashes
Conditions
Keywords
soy, menopause, hot flash
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.
Interventions
OTHERlow-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.
Sponsors
Physicians Committee for Responsible Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The control group will be asked to stay on their usual diet.
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.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| PDI, hPDI, uPDI | 16 weeks | Assess the total plant-based index (PDI), healthy PDI, and unhealthy PDI, and their relationship with weight loss. |
| 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. |
| Ultraprocessed foods | 16 weeks | The consumption of ultraprocessed foods will be assessed, using the NOVA classification, at baseline and 16 weeks. |
| Dietary Advanced Glycation End Products (AGEs) | 16 weeks | Explore the effectiveness of a vegan diet in reducing dietary AGEs. |
Countries
United States
Outcome results
None listed