Womens Study to Alleviate Vasomotor Symptoms (WAVS)

• ClinicalTrials.gov Identifier: NCT04587154
• Recruitment Status: Active, not recruiting
• First Posted: October 14, 2020
• Last Update Posted: March 9, 2023
• Sponsor: Physicians Committee for Responsible Medicine
• Information provided by (Responsible Party): Physicians Committee for Responsible Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hot Flashes	Other: low-fat vegan diet with 1/2 cup soybeans daily	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Single (Investigator)
• Masking Description: The control group will be asked to stay on their usual diet.
• Primary Purpose: Treatment
• Official Title: Womens Study to Alleviate Vasomotor Symptoms
• Actual Study Start Date: September 9, 2020
• Actual Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Group; 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; Weekly instructions will be given to the participants in the intervention group about following vegan diet with 1/2 cup of soybeans daily.; Other Name: Vegan diet
No Intervention: Control Group; 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.

Outcome Measures

Primary Outcome Measures :

1. Rate of Hot Flash [ Time Frame: 12 weeks ]
   Incidents Induced by Menopause. Hot flashes will be recorded using the MyLuna application, available in the App Store for iPhone or Android.
2. Menopause Quality of Life Questionnaire (MENQOL) [ Time Frame: 12 weeks ]
   Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)

Secondary Outcome Measures :

1. Weight Change [ Time Frame: 12 weeks ]
   Body weight changes, which will be measured weekly using a Renfro scale sent out to participants in both groups.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: This study only seeks people who have had their last period, thus excluding males.
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, District of Columbia

Physicians Committee for Responsible Medicine

Washington, District of Columbia, United States, 20016

Sponsors and Collaborators

Physicians Committee for Responsible Medicine

Investigators

• Principal Investigator: Neal Barnard, MD, FACC; President

More Information

Publications:

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

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

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?.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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. Erratum In: Maturitas 1996 Nov;25(3):231.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Physicians Committee for Responsible Medicine
• ClinicalTrials.gov Identifier: NCT04587154
• Other Study ID Numbers: Pro00045315
• First Posted: October 14, 2020
• Last Update Posted: March 9, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Physicians Committee for Responsible Medicine:

soy; menopause; hot flash

Additional relevant MeSH terms:

Hot Flashes