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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change | Body weight changes, which will be measured weekly using a Renfro scale sent out to participants in both groups. | 12 weeks |
| Dietary Advanced Glycation End Products (AGEs) | Explore the effectiveness of a vegan diet in reducing dietary AGEs. |
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Inclusion Criteria:
Exclusion Criteria:
This study only seeks people who have had their last period, thus excluding males.
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| Name | Affiliation | Role |
|---|---|---|
| Neal Barnard, MD, FACC | President | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Committee for Responsible Medicine | Washington D.C. | District of Columbia | 20016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 9710286 | Background | Lock M. Menopause: lessons from anthropology. Psychosom Med. 1998 Jul-Aug;60(4):410-9. doi: 10.1097/00006842-199807000-00005. | |
| 15879913 |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000067269 | Diet, Vegan |
| ID | Term |
|---|---|
| D014676 | Diet, Vegetarian |
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
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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.
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The control group will be asked to stay on their usual diet.
|
| 16 weeks |
| PDI, hPDI, uPDI | Assess the total plant-based index (PDI), healthy PDI, and unhealthy PDI, and their relationship with weight loss. | 16 weeks |
| Ultraprocessed foods | The consumption of ultraprocessed foods will be assessed, using the NOVA classification, at baseline and 16 weeks. | 16 weeks |
| 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 |
| 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?. |
| 17048096 | 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. |
| 15919681 | 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. |
| 11400221 | 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. |
| 11910681 | 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. |
| 11296152 | 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. |
| 19434877 | 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. |
| 16837885 | 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. |
| 24323914 | 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. |
| 27327802 | 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. |
| 21961716 | 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. |
| 6961471 | 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. |
| 29720928 | 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. |
| 8844630 | 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. |
| 15734602 | 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. |
| 40663878 | Derived | 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. |
| 39580383 | 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. |
| 37084590 | 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. |
| 36253903 | 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. |
| 34260478 | 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. |
| D013812 |
| Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |