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Women's Isoflavone Soy Health (WISH) Trial
Phase 2 trial testing 25 gm soy protein supplement in Atherosclerosis in 350 participants. Completed in 19 March 2009.
| Lead sponsor | University of Southern California |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 350 |
| Start date | 12 April 2004 |
| Primary completion | 19 March 2009 |
| Estimated completion | 19 March 2009 |
| Sites | 1 location across United States |
University of Southern California
30 and older, female only, with Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Isoflavone Soy Protein (ISP) Supplementation | 4.77 | 3.39 – 6.16 |
| Placebo | 5.68 | 4.30 – 7.06 |
The specified primary cognitive endpoint compared between treatment groups was change from baseline on a global cognitive composite score calculated as an average of standardized scores for 14 neuropsychological tests weighted by the inverse intertest correlation matrix. Neuropsychological test scores at baseline and follow-up assessments were standardized (\[raw score-mean score\]/standard deviation) using the baseline means and standard deviations from the entire WISH sample. Each of 3 cognitive composite scores was calculated at baseline and follow-up as the weighted average of the individu
| Group | Value | 95% CI |
|---|---|---|
| Isoflavone Soy Protein (ISP) Supplementation | 0.42 | ± 0.09 |
| Placebo | 0.31 | ± 0.08 |
Time frame: Adverse event data were collected for up to 2.5 years for each participant.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Isoflavone Soy Protein (IS… | Placebo |
|---|---|---|---|
| Non-Cardiac Chest Pain | General disorders | — | — |
| Cold/Flu | Infections and infestations | — | — |
| Back Pain/Spasm/Strain/Sprain/Twisted/Hurt/Discomfort | Musculoskeletal and connective tissue disorders | — | — |
| Knee Replacement/Surgery | Surgical and medical procedures | — | — |
| Gums/Implant/Sore/Infection/Surgery | Surgical and medical procedures | — | — |
| Foot Problems/Plantar Fasciitis/Foot Drop/Infection/Bones Spur Removal/Bunionectomy/Hammertoe | Surgical and medical procedures | — | — |
| Gallbladder Surgery/Laparoscopic Cholecystectomy | Surgical and medical procedures | — | — |
| Fibroids Tumor/Removal | Surgical and medical procedures | — | — |
| Vaginal Dryness | Reproductive system and breast disorders | — | — |
| Vaginal Infection | Reproductive system and breast disorders | — | — |
| Hysterectomy/Partial/Total/Vaginal | Surgical and medical procedures | — | — |
| Shingles | Skin and subcutaneous tissue disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| Skin tags removal | Surgical and medical procedures | — | — |
| Near/Syncopal/Episode | Nervous system disorders | — | — |
| Colon Cancer/Removal | Surgical and medical procedures | — | — |
| In Situ/Ductal Carcinoma-Breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Lobular Carcinoma-Breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Endometrial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Dizziness/Light Headed | Nervous system disorders | — | — |
| Stroke | Vascular disorders | — | — |
| Thrombophlebitis | Vascular disorders | — | — |
| Cardiac Angiogram | Investigations | — | — |
| Pulmonary Angiogram | Investigations | — | — |
| Eye Infection | Eye disorders | — | — |
| Reaction | System | Isoflavone Soy Protein (IS… | Placebo |
|---|---|---|---|
| Cold/Flu | Infections and infestations | — | — |
| Urinary Tract Infection | Renal and urinary disorders | — | — |
| Upper Extremity/Swelling/Stiffness/Pain/Strain/Injury/Cramps/Itching | General disorders | — | — |
| Abdominal Bloating/Distension/Gas | Gastrointestinal disorders | — | — |
| Lower Extremity/Swelling/Stiffness/Pain/Strain/Injury/Cramps/Itching | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Non-Cardiac Chest Pain | General disorders | — | — |
| Arthritis/Pain | Musculoskeletal and connective tissue disorders | — | — |
| Vaginal Spotting/Bleeding/Discharge | Reproductive system and breast disorders | — | — |
| Sinus Condition/Sinusitis/Sinus Headache/Head Congestion | General disorders | — | — |
| Fall | General disorders | — | — |
| Vomiting/Nausea | Gastrointestinal disorders | — | — |
| Fracture | Musculoskeletal and connective tissue disorders | — | — |
| Sore/Irritation/Strep Throat | Infections and infestations | — | — |
| Back Pain/Spasm/Strain/Sprain/Twisted/Hurt/Discomfort | Musculoskeletal and connective tissue disorders | — | — |
| Breast Pain | Reproductive system and breast disorders | — | — |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Diarrhea/Loose Stool | Gastrointestinal disorders | — | — |
| Cataract Surgery/Removal | Eye disorders | — | — |
| Headache/Migraine | Nervous system disorders | — | — |
Most-reported serious reactions: Non-Cardiac Chest Pain, Cold/Flu, Back Pain/Spasm/Strain/Sprain/Twisted/Hurt/Discomfort, Knee Replacement/Surgery, Gums/Implant/Sore/Infection/Surgery, Foot Problems/Plantar Fasciitis/Foot Drop/Infection/Bones Spur Removal/Bunionectomy/Hammertoe, Gallbladder Surgery/Laparoscopic Cholecystectomy, Fibroids Tumor/Removal.
Data from ClinicalTrials.gov NCT00118846 adverse events section.
The purpose of this study is to determine whether soy supplementation can reduce hardening of the arteries and cognitive decline in postmenopausal women.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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