Womens Study to Alleviate Vasomotor Symptoms

NCT04587154 | Completed DMC

• 1 other identifier: Pro00045315
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flashes

Keywords

soy; menopause; hot flash

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks

• Menopause Quality of Life Questionnaire (MENQOL)

  Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)

  12 weeks

Secondary Outcomes (5)

• Weight Change

  12 weeks

• Dietary Advanced Glycation End Products (AGEs)

  16 weeks

• PDI, hPDI, uPDI

  16 weeks

• Ultraprocessed foods

  16 weeks

• Carbon Footprint

  16 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

low-fat vegan diet with 1/2 cup soybeans daily OTHER

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

Intervention Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: This study only seeks people who have had their last period, thus excluding males.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Post-menopausal women aged 40-60 years
• English fluency
• Moderate-to-severe hot flashes experienced at least twice per day
• Started menopause within the last 10 years
• No menses in preceding 12 months
• Access to an iPhone or Android phone and willingness to install a hot-flash recording app.
• Willingness to participate in weekly classes
• Willingness to follow a low-fat vegan diet, including daily consumption of soybeans.

You may not qualify if:

• Use of hormonal medications in the preceding 2 months
• An explanation for hot flashes other than menopause (e.g., medication use, cancer treatment)
• Smoking during the past six months
• 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)
• 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
• Use of recreational drugs in the past 6 months
• Use of weight-loss medications over the last 6 months or a current attempt to lose weight
• Body Mass Index \< 18.5 kg/m2
• Soy allergy

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead

Study Sites (1)

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

Location

Related Publications (22)

• American College of Obstetrics and Gynecology. Response to Women's Health Initiative Study Results by The American College of Obstetricians and Gynecologists, August 9, 2002. Internet: http://www.losolivos-obgyn.com/info/gynecology/menopause/acog_whi_2002.pdf

  BACKGROUND

• Lock M. Menopause: lessons from anthropology. Psychosom Med. 1998 Jul-Aug;60(4):410-9. doi: 10.1097/00006842-199807000-00005.

  PMID: 9710286 BACKGROUND

• Melby MK. Vasomotor symptom prevalence and language of menopause in Japan. Menopause. 2005 May-Jun;12(3):250-7. doi: 10.1097/01.gme.0000146108.27840.d9?.

  PMID: 15879913 BACKGROUND

• Shea JL. Cross-cultural comparison of women's midlife symptom-reporting: a China study. Cult Med Psychiatry. 2006 Sep;30(3):331-62. doi: 10.1007/s11013-006-9020-4.

  PMID: 17048096 BACKGROUND

• Melby MK, Lock M, Kaufert P. Culture and symptom reporting at menopause. Hum Reprod Update. 2005 Sep-Oct;11(5):495-512. doi: 10.1093/humupd/dmi018. Epub 2005 May 26.

  PMID: 15919681 BACKGROUND

• Beyene Y, Martin MC. Menopausal experiences and bone density of Mayan women in Yucatan, Mexico. Am J Hum Biol. 2001 Jul-Aug;13(4):505-11. doi: 10.1002/ajhb.1082.

  PMID: 11400221 BACKGROUND

• Nagata C, Shimizu H, Takami R, Hayashi M, Takeda N, Yasuda K. Hot flushes and other menopausal symptoms in relation to soy product intake in Japanese women. Climacteric. 1999 Mar;2(1):6-12. doi: 10.3109/13697139909025557.

  PMID: 11910681 BACKGROUND

• Nagata C, Takatsuka N, Kawakami N, Shimizu H. Soy product intake and hot flashes in Japanese women: results from a community-based prospective study. Am J Epidemiol. 2001 Apr 15;153(8):790-3. doi: 10.1093/aje/153.8.790.

  PMID: 11296152 BACKGROUND

• Murkies AL, Lombard C, Strauss BJ, Wilcox G, Burger HG, Morton MS. Dietary flour supplementation decreases post-menopausal hot flushes: effect of soy and wheat. Maturitas. 2008 Sep-Oct;61(1-2):27-33. doi: 10.1016/j.maturitas.2008.09.007.

  PMID: 19434877 BACKGROUND

• Lewis JE, Nickell LA, Thompson LU, Szalai JP, Kiss A, Hilditch JR. A randomized controlled trial of the effect of dietary soy and flaxseed muffins on quality of life and hot flashes during menopause. Menopause. 2006 Jul-Aug;13(4):631-42. doi: 10.1097/01.gme.0000191882.59799.67.

  PMID: 16837885 BACKGROUND

• Lethaby A, Marjoribanks J, Kronenberg F, Roberts H, Eden J, Brown J. Phytoestrogens for menopausal vasomotor symptoms. Cochrane Database Syst Rev. 2013 Dec 10;2013(12):CD001395. doi: 10.1002/14651858.CD001395.pub4.

  PMID: 24323914 BACKGROUND

• Franco OH, Chowdhury R, Troup J, Voortman T, Kunutsor S, Kavousi M, Oliver-Williams C, Muka T. Use of Plant-Based Therapies and Menopausal Symptoms: A Systematic Review and Meta-analysis. JAMA. 2016 Jun 21;315(23):2554-63. doi: 10.1001/jama.2016.8012.

  PMID: 27327802 BACKGROUND

• Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489-501. doi: 10.1016/j.ogc.2011.05.006.

  PMID: 21961716 BACKGROUND

• Garner DM, Olmsted MP, Bohr Y, Garfinkel PE. The eating attitudes test: psychometric features and clinical correlates. Psychol Med. 1982 Nov;12(4):871-8. doi: 10.1017/s0033291700049163.

  PMID: 6961471 BACKGROUND

• Svendsen K, Henriksen HB, Ostengen B, Jacobs DR Jr, Telle-Hansen VH, Carlsen MH, Retterstol K. Evaluation of a short Food Frequency Questionnaire to assess cardiovascular disease-related diet and lifestyle factors. Food Nutr Res. 2018 Apr 19;62. doi: 10.29219/fnr.v62.1370. eCollection 2018.

  PMID: 29720928 BACKGROUND

• Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.

  PMID: 8844630 BACKGROUND

• Lewis JE, Hilditch JR, Wong CJ. Further psychometric property development of the Menopause-Specific Quality of Life questionnaire and development of a modified version, MENQOL-Intervention questionnaire. Maturitas. 2005 Mar 14;50(3):209-21. doi: 10.1016/j.maturitas.2004.06.015.

  PMID: 15734602 BACKGROUND

• Kahleova H, Znayenko-Miller T, Holubkov R, Barnard ND. Isoflavones and changes in body weight and severe hot flashes in postmenopausal women: A secondary analysis of a randomized clinical trial. Maturitas. 2025 Sep;200:108661. doi: 10.1016/j.maturitas.2025.108661. Epub 2025 Jul 5.

  PMID: 40663878 DERIVED

• Brennan H, Znayenko-Miller T, Sutton M, Holubkov R, Barnard ND, Kahleova H. Diet quality, body weight, and postmenopausal hot flashes: a secondary analysis of a randomized clinical trial. BMC Womens Health. 2024 Nov 23;24(1):620. doi: 10.1186/s12905-024-03467-4.

  PMID: 39580383 DERIVED

• Kahleova H, Znayenko-Miller T, Uribarri J, Schmidt N, Kolipaka S, Hata E, Holtz DN, Sutton M, Holubkov R, Barnard ND. Dietary advanced glycation end-products and postmenopausal hot flashes: A post-hoc analysis of a 12-week randomized clinical trial. Maturitas. 2023 Jun;172:32-38. doi: 10.1016/j.maturitas.2023.03.008. Epub 2023 Mar 24.

  PMID: 37084590 DERIVED

• Barnard ND, Kahleova H, Holtz DN, Znayenko-Miller T, Sutton M, Holubkov R, Zhao X, Galandi S, Setchell KDR. A dietary intervention for vasomotor symptoms of menopause: a randomized, controlled trial. Menopause. 2023 Jan 1;30(1):80-87. doi: 10.1097/GME.0000000000002080. Epub 2022 Oct 16.

  PMID: 36253903 DERIVED

• Barnard ND, Kahleova H, Holtz DN, Del Aguila F, Neola M, Crosby LM, Holubkov R. 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. Menopause. 2021 Jul 12;28(10):1150-1156. doi: 10.1097/GME.0000000000001812.

  PMID: 34260478 DERIVED

MeSH Terms

Conditions

Hot Flashes

Interventions

Diet, Vegan

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Neal Barnard, MD, FACC

  President

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The control group will be asked to stay on their usual diet.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: September 9, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

US (1)