Womens Study to Alleviate Vasomotor Symptoms

Hot Flashes Clinical Trial

— WAVS  

Official title:

Womens Study to Alleviate Vasomotor Symptoms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04587154
• Other study ID #: Pro00045315
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Physicians Committee for Responsible Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hot Flashes

Intervention

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.

Locations

Country	Name	City	State
United States	Physicians Committee for Responsible Medicine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine

Country where clinical trial is conducted

United States, 

References & Publications (17)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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?. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Menopause Quality of Life Questionnaire (MENQOL)	Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)	12 weeks
Secondary	Weight Change	Body weight changes, which will be measured weekly using a Renfro scale sent out to participants in both groups.	12 weeks
Secondary	Dietary Advanced Glycation End Products (AGEs)	Explore the effectiveness of a vegan diet in reducing dietary AGEs.	16 weeks
Secondary	PDI, hPDI, uPDI	Assess the total plant-based index (PDI), healthy PDI, and unhealthy PDI, and their relationship with weight loss.	16 weeks
Secondary	Ultraprocessed foods	The consumption of ultraprocessed foods will be assessed, using the NOVA classification, at baseline and 16 weeks.	16 weeks
Secondary	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.	16 weeks