Women's Isoflavone Soy Health (WISH) Trial
Phytoestrogens and Progression of Atherosclerosis
4 other identifiers
interventional
350
1 country
1
Brief Summary
The purpose of this study is to determine whether soy supplementation can reduce hardening of the arteries and cognitive decline in postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2004
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2004
CompletedFirst Submitted
Initial submission to the registry
July 7, 2005
CompletedFirst Posted
Study publicly available on registry
July 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2009
CompletedResults Posted
Study results publicly available
May 6, 2023
CompletedMay 6, 2023
April 1, 2023
4.9 years
July 7, 2005
March 17, 2023
April 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression of Subclinical Atherosclerosis
Rate of change in right distal common carotid artery (CCA) far wall intima-media thickness (um per year) in computer image processed B-mode ultrasonograms.
Baseline x 2 and then every 6 months, up to 2.5 years
Secondary Outcomes (1)
Change in Neurocognitive Function (Global Cognition)
Baseline and 2.5 years
Study Arms (2)
Isoflavone Soy Protein (ISP) Supplementation
ACTIVE COMPARATOR25 gm soy protein supplementation administered twice daily in equivalent dosages (12.5 gm)
Placebo
PLACEBO COMPARATORMilk protein matching placebo administered twice daily in equivalent dosages
Interventions
25 gm soy protein supplementation administered in equally divided dosage twice daily (12.5 gm)
Eligibility Criteria
You may qualify if:
- Postmenopausal, defined as no vaginal bleeding for at least 1 year and serum estradiol level lower than 20 pg/ml
You may not qualify if:
- Signs, symptoms or personal history of cardiovascular disease
- Diabetes mellitus or fasting serum glucose of 126 mg/dL or greater
- Fasting plasma triglyceride of 500 mg/dL or greater
- Serum creatinine greater than 2.0 mg/dL
- Uncontrolled hypertension
- Untreated thyroid disease
- Life expectancy less than 5 years
- Current use of hormone replacement therapy (HRT)
- Soy, nut, or related food allergies
- More than 5 alcohol drinks per day or substance abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Center for Complementary and Integrative Health (NCCIH)collaborator
- Office of Dietary Supplements (ODS)collaborator
- Office of Research on Women's Health (ORWH)collaborator
- Solae, LLCcollaborator
Study Sites (1)
Atherosclerosis Research Unit, University of Southern California
Los Angeles, California, 90033, United States
Related Publications (4)
Hodis HN, Mack WJ, Kono N, Azen SP, Shoupe D, Hwang-Levine J, Petitti D, Whitfield-Maxwell L, Yan M, Franke AA, Selzer RH; Women's Isoflavone Soy Health Research Group. Isoflavone soy protein supplementation and atherosclerosis progression in healthy postmenopausal women: a randomized controlled trial. Stroke. 2011 Nov;42(11):3168-75. doi: 10.1161/STROKEAHA.111.620831. Epub 2011 Sep 8.
PMID: 21903957RESULTHenderson VW, St John JA, Hodis HN, Kono N, McCleary CA, Franke AA, Mack WJ; WISH Research Group. Long-term soy isoflavone supplementation and cognition in women: a randomized, controlled trial. Neurology. 2012 Jun 5;78(23):1841-8. doi: 10.1212/WNL.0b013e318258f822.
PMID: 22665144RESULTLin F, Pa J, Karim R, Hodis HN, Han SD, Henderson VW, St John JA, Mack WJ. Subclinical carotid artery atherosclerosis and cognitive function in older adults. Alzheimers Res Ther. 2022 May 7;14(1):63. doi: 10.1186/s13195-022-00997-7.
PMID: 35526057DERIVEDQuaas AM, Kono N, Mack WJ, Hodis HN, Felix JC, Paulson RJ, Shoupe D. Effect of isoflavone soy protein supplementation on endometrial thickness, hyperplasia, and endometrial cancer risk in postmenopausal women: a randomized controlled trial. Menopause. 2013 Aug;20(8):840-4. doi: 10.1097/GME.0b013e3182804353.
PMID: 23422867DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Howard N. Hodis, M.D.
- Organization
- Director, Atherosclerosis Research Unit, University of Southern California
Study Officials
- PRINCIPAL INVESTIGATOR
Howard N. Hodis, M.D.
Atherosclerosis Research Unit, University of Southern California
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Harry J. Bauer and Dorothy Bauer Rawlins Professor of Cardiology, Professor of Medicine, Population and Public Health Sciences, and Molecular Pharmacology and Toxicology, Director, Atherosclerosis Research Unit
Study Record Dates
First Submitted
July 7, 2005
First Posted
July 12, 2005
Study Start
April 12, 2004
Primary Completion
March 19, 2009
Study Completion
March 19, 2009
Last Updated
May 6, 2023
Results First Posted
May 6, 2023
Record last verified: 2023-04