An interventional study of low-fat vegan diet with 1/2 cup soybeans daily in Hot Flashes, sponsored by Physicians Committee for Responsible Medicine. Completed at 1 site in United States. Open to female participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Physicians Committee for Responsible Medicine · Not applicable, Interventional, and Treatment
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.
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.
285 studies on the registry are indexed under Hot Flashes; 50 are open to participants now.
This study's enrollment of 80 is below the median of 90 across 255 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →Physicians Committee for Responsible Medicine is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Weekly instructions will be given to the participants in the intervention group about following vegan diet with 1/2 cup of soybeans daily.
Also known as: Vegan diet
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.
Time frame: 12 weeks
Menopause Quality of Life Questionnaire (MENQOL)
Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)
Time frame: 12 weeks
Weight Change
Body weight changes, which will be measured weekly using a Renfro scale sent out to participants in both groups.
Time frame: 12 weeks
Dietary Advanced Glycation End Products (AGEs)
Explore the effectiveness of a vegan diet in reducing dietary AGEs.
Time frame: 16 weeks
PDI, hPDI, uPDI
Assess the total plant-based index (PDI), healthy PDI, and unhealthy PDI, and their relationship with weight loss.
Time frame: 16 weeks
Ultraprocessed foods
The consumption of ultraprocessed foods will be assessed, using the NOVA classification, at baseline and 16 weeks.
Time frame: 16 weeks
Carbon Footprint
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.
Time frame: 16 weeks
Plan to share: Undecided
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Physicians Committee for Responsible Medicine