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Randomized Controlled Trial
. 2023 Jan 1;30(1):80-87.
doi: 10.1097/GME.0000000000002080. Epub 2022 Oct 16.

A dietary intervention for vasomotor symptoms of menopause: a randomized, controlled trial

Neal D Barnard, Hana Kahleova  1 , Danielle N Holtz  1 , Tatiana Znayenko-Miller  1 , Macy Sutton  1 , Richard Holubkov  2 , Xueheng Zhao  3 , Stephanie Galandi  3 , Kenneth D R Setchell
Affiliations
Randomized Controlled Trial

A dietary intervention for vasomotor symptoms of menopause: a randomized, controlled trial

Neal D Barnard et al. Menopause. .

Abstract

Objective: Postmenopausal vasomotor symptoms disrupt quality of life. This study tested the effects of a dietary intervention on vasomotor symptoms and menopause-related quality of life.

Methods: Postmenopausal women (n = 84) reporting at least two moderate-to-severe hot flashes daily were randomly assigned, in two successive cohorts, to an intervention including a low-fat, vegan diet and cooked soybeans (½ cup [86 g] daily) or to a control group making no dietary changes. During a 12-week period, a mobile application was used to record hot flashes (frequency and severity), and vasomotor, psychosocial, physical, and sexual symptoms were assessed with the Menopause-Specific Quality of Life questionnaire. Between-group differences were assessed for continuous ( t tests) and binary ( χ2 /McNemar tests) outcomes. In a study subsample, urinary equol was measured after the consumption of ½ cup (86 g) of cooked whole soybeans twice daily for 3 days.

Results: In the intervention group, moderate-to-severe hot flashes decreased by 88% ( P < 0.001) compared with 34% for the control group ( P < 0.001; between-group P < 0.001). At 12 weeks, 50% of completers in the intervention group reported no moderate-to-severe hot flashes at all. Among controls, there was no change in this variable from baseline ( χ2 test, P < 0.001). Neither seasonality nor equol production status was associated with the degree of improvement. The intervention group reported greater reductions in the Menopause-Specific Quality of Life questionnaire vasomotor ( P = 0.004), physical ( P = 0.01), and sexual ( P = 0.03) domains.

Conclusions: A dietary intervention consisting of a plant-based diet, minimizing oils, and daily soybeans significantly reduced the frequency and severity of postmenopausal hot flashes and associated symptoms.

Trial registration: ClinicalTrials.gov NCT04587154.

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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. H.K., D.N.H., T.Z.-M., M.S., and R.H. received compensation from the Physicians Committee for Responsible Medicine for their work on this study. R.H. currently receives funding from Pfizer for Data Safety and Monitoring Board service and DURECT Corporation for biostatistical consulting. He has received funding from Revance for Data Safety and Monitoring Board consulting in the past. K.D.R.S. holds equity in Aliveris s.r.l., Asklepion Pharmaceuticals, and Ausio Pharmaceuticals, and is a consultant to Travere and Mirum Pharmaceuticals.

Figures

FIG. 1
FIG. 1
Participant flow through the trial. MENQOL, Menopause-Specific Quality of Life questionnaire.
FIG. 2
FIG. 2
Moderate-to-severe hot flashes (per day, with 95% CI, completers). CI, confidence interval.
See this image and copyright information in PMC

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