CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 350 enrolled
Drug / intervention
25 gm soy protein supplement +1 moredietary
Likely dose
Soy protein 25 gm daily in divided doses (12.5 gm twice daily)AI-extracted
Key inclusion· 1
  • ✓Postmenopausal status defined as no vaginal bleeding for ≥1 year AND serum estradiol <20 pg/mL
Key exclusion· 10
  • ✕Signs, symptoms, or personal history of cardiovascular disease
  • ✕Diabetes mellitus or fasting serum glucose ≥126 mg/dL
  • ✕Fasting plasma triglyceride ≥500 mg/dL
  • ✕Serum creatinine >2.0 mg/dL

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00118846
NCT00118846Phase 2Completed
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Phytoestrogens and Progression of Atherosclerosis

University of Southern California·interventional·Posted Jul 12, 2005·Updated May 6, 2023

In Brief

A Phase 2 clinical trial evaluating 25 gm soy protein supplement and Placebo for Atherosclerosis. Completed, enrolled 350 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether soy supplementation can reduce hardening of the arteries and cognitive decline in postmenopausal women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerosis
CountriesUnited States
CollaboratorsNational Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS), Office of Research on Women's Health (ORWH), Solae, LLC

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2005
Enrollment StartApr 12, 2004
Primary CompletionMar 19, 2009
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 21.0 years ago

Interventions

25 gm soy protein supplementdietary

25 gm soy protein supplementation administered in equally divided dosage twice daily (12.5 gm)

Placeboother

Milk protein administered twice daily