The Women's Study for the Alleviation of Vasomotor Symptoms (WAVS): a randomized, controlled trial of a plant-based diet and whole soybeans for postmenopausal women

Neal D Barnard, Hana Kahleova, Danielle N Holtz, Fabiola Del Aguila, Maggie Neola, Lelia M Crosby, Richard Holubkov, Neal D Barnard, Hana Kahleova, Danielle N Holtz, Fabiola Del Aguila, Maggie Neola, Lelia M Crosby, Richard Holubkov

Abstract

Objective: This study aimed to assess the effects of the combination of a low-fat plant-based diet and soybeans on the frequency and severity of menopausal hot flashes.

Methods: Postmenopausal women (n = 38) reporting two or more hot flashes/day were randomly assigned to a low-fat, vegan diet, including ½ cup (86 g) of cooked soybeans daily, or to no diet changes for 12 weeks. Frequency and severity of hot flashes were recorded using a mobile application, and vasomotor, psychosocial, physical, and sexual symptoms were assessed using the Menopause-Specific Quality of Life Questionnaire. Significance was assessed using t-tests (continuous outcomes) and chi-squared/McNemar tests (binary outcomes).

Results: Total hot flashes decreased 79% in the intervention group (P < 0.001) and 49% in the control group (P = 0.002; between-group P = 0.01). Moderate-to-severe hot flashes decreased 84% in the intervention group (P < 0.001) and 42% in the control group P = 0.009; between-group P = 0.01). From 0 to 12 weeks, 59% (10/17) of intervention-group participants reported becoming free of moderate and severe hot flashes (P = 0.002). There was no change in this variable in the control group (between-group P < 0.001). The Menopause-Specific Quality of Life Questionnaire revealed significantly greater reductions in the intervention group in vasomotor (P < 0.0001), psychosocial (P = 0.04), physical (P < 0.002), and sexual (P = 0.01) domains.

Conclusions: The combination of a low-fat, vegan diet and whole soybeans was associated with reduced frequency and severity of hot flashes and improved quality of life in vasomotor, psychosocial, physical, and sexual domains in postmenopausal women. During the 12-week study period, the majority of intervention-group participants became free of moderate-to-severe hot flashes.

Trial registration: ClinicalTrials.gov NCT04587154.

Conflict of interest statement

Financial disclosure/conflicts of interest: N.D.B. is an Adjunct Professor of Medicine at the George Washington University School of Medicine. He serves without compensation as president of the Physicians Committee for Responsible Medicine and Barnard Medical Center in Washington, DC, nonprofit organizations providing educational, research, and medical services related to nutrition. He writes books and articles and gives lectures related to nutrition and health and has received royalties and honoraria from these sources. L.M.C. is the author of the nutrition blog Veggie Quest, and a trust for her benefit previously owned shares in Walgreen's, 3M, and Johnson & Johnson. H.K., D.N.H., F.A., M.N., L.M.C., and R.H. received compensation from the Physicians Committee for Responsible Medicine for their work on this study. R.H. receives funding for being on data safety monitoring boards of Pfizer and Revance.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The North American Menopause Society.

Figures

FIG. 1
FIG. 1
Participant flow through the trial. MENQOL, The Menopause Specific Quality of Life Questionnaire.

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Source: PubMed

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