Hot FlashesWAVSNCT04587154

Womens Study to Alleviate Vasomotor Symptoms

A study testing low-fat vegan diet with 1/2 cup soybeans daily in people with Hot Flashes, run by Physicians Committee for Responsible Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 40 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Hot Flashes
What is being tested?: low-fat vegan diet with 1/2 cup soybeans daily
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 9 Sep 2020to 31 Jul 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, 20016

Other trials in United States

About this study

Read the 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.

Conditions: Hot Flashes
Being tested: low-fat vegan diet with 1/2 cup soybeans daily
Keywords: soy, menopause, hot flash
Medical subject headings: Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

low-fat vegan diet with 1/2 cup soybeans dailyOther
Also called Vegan diet
Weekly instructions will be given to the participants in the intervention group about following vegan diet with 1/2 cup of soybeans daily.

Study groups in NCT04587154
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks
Menopause Quality of Life Questionnaire (MENQOL)
Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)
Measured: 12 weeks

Secondary outcomes (5)

Weight Change
Body weight changes, which will be measured weekly using a Renfro scale sent out to participants in both groups.
Measured: 12 weeks
Dietary Advanced Glycation End Products (AGEs)
Explore the effectiveness of a vegan diet in reducing dietary AGEs.
Measured: 16 weeks
PDI, hPDI, uPDI
Assess the total plant-based index (PDI), healthy PDI, and unhealthy PDI, and their relationship with weight loss.
Measured: 16 weeks
Ultraprocessed foods
The consumption of ultraprocessed foods will be assessed, using the NOVA classification, at baseline and 16 weeks.
Measured: 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.
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 202031 Jul 2021

First posted14 Oct 2020
Study start9 Sep 2020
Primary completion31 Jul 2021
Study completion31 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Hot FlashesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04587154
Sponsor's protocol ID: Pro00045315
Acronym: WAVS
Status last verified: Jun 2025
First submitted: 6 Oct 2020
Last updated: 27 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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.
PubMed 9710286
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?.
PubMed 15879913
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.
PubMed 17048096
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.
PubMed 15919681
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.
PubMed 11400221
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.
PubMed 11910681
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.
PubMed 11296152
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.
PubMed 19434877
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.
PubMed 16837885
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.
PubMed 24323914
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.
PubMed 27327802
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.
PubMed 21961716
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.
PubMed 6961471
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.
PubMed 29720928

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Menopause, Menopause Hot Flashes
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Hot Flashes
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer

All Hot Flashes trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Womens Study to Alleviate Vasomotor Symptoms
ClinicalTrials.gov ID: NCT04587154
Acronym / sponsor ID: WAVS / Pro00045315
Conditions: Hot Flashes
Keywords: soy, menopause, hot flash
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Physicians Committee for Responsible MedicineUniversity, hospital or other
Study start: 9 Sep 2020 (actual)
Primary completion: 31 Jul 2021 (actual)
Study completion: 31 Jul 2021 (actual)
First posted: 14 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
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.

Arm	Type	Receives
Intervention Group	Experimental	Other: low-fat vegan diet with 1/2 cup soybeans dailyThis 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.

Who may qualify

Ages: 40 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
low-fat vegan diet with 1/2 cup soybeans dailyAlso: Vegan dietWeekly instructions will be given to the participants in the intervention group about following vegan diet with 1/2 cup of soybeans daily.	Other	Intervention Group

Primary outcome

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.
Menopause Quality of Life Questionnaire (MENQOL)
Time frame: 12 weeks
Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)

5 secondary outcomes

Weight Change
Time frame: 12 weeks
Dietary Advanced Glycation End Products (AGEs)
Time frame: 16 weeks
PDI, hPDI, uPDI
Time frame: 16 weeks
Ultraprocessed foods
Time frame: 16 weeks
Carbon Footprint
Time frame: 16 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
BackgroundAmerican 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: PubMed 9710286Lock M. Menopause: lessons from anthropology. Psychosom Med. 1998 Jul-Aug;60(4):410-9. doi: 10.1097/00006842-199807000-00005.
Background: PubMed 15879913Melby 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?.
Background: PubMed 17048096Shea 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.
Background: PubMed 15919681Melby 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.
Background: PubMed 11400221Beyene 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.
Background: PubMed 11910681Nagata 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.
Background: PubMed 11296152Nagata 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.
Background: PubMed 19434877Murkies 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.
Background: PubMed 16837885Lewis 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.
Background: PubMed 24323914Lethaby 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.
Background: PubMed 27327802Franco 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.
Individual participant dataSharing planned: Undecided

Related trials for Hot Flashes

RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
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RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Neal Barnard, MD, FACC principal investigator

President

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing low-fat vegan diet with 1/2 cup soybeans daily in people with Hot Flashes, run by Physicians Committee for Responsible Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Hot Flash (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04587154, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.