CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 352 enrolled
Drug / intervention
Soy protein-milk protein-carbohydrate +2 moredietary
Likely dose
40 grams of soy protein per day, 40 grams of milk protein per day, and 40 grams of carbohydrate per day for 8 weeksAI-extracted
Key inclusion· 2
  • Systolic BP 120–159 mm Hg and diastolic BP 80–95 mm Hg (average of 6 measurements at 2 screening visits)
  • Willing to participate in all aspects of the study
Key exclusion· 10
  • Consumption of dietary protein ≥1.63 g/kg/day by 24-hour dietary recall
  • Stage-2 or higher hypertension (systolic ≥160 mm Hg or diastolic ≥95 mm Hg)
  • Use of antihypertensive medications or medications affecting blood pressure
  • History of clinical heart disease (angina, heart attack, coronary revascularization, heart failure, stroke, TIA, peripheral arterial disease)

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

Search/NCT00107744
NCT00107744N/ACompleted

Clinical Trial of Protein and Blood Pressure

Tulane University·interventional·Posted Apr 8, 2005·Updated Apr 12, 2023

In Brief

A clinical study evaluating Soy protein-milk protein-carbohydrate, Milk protein-carbohydrate-soy protein, and 1 other intervention for Hypertension and Hypercholesterolemia. Completed, enrolled 352 participants.

Detailed Summary

The purpose of this randomized, double-blind, controlled trial is to examine the effect of soybean protein supplementation on blood pressure in persons with prehypertension or stage-1 hypertension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 8, 2005
Enrollment StartSep 1, 2003
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 21.2 years ago

Interventions

Soy protein-milk protein-carbohydratedietary

40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks, and 40 grams of carbohydrate per day for 8 weeks

Milk protein-carbohydrate-soy proteindietary

40 grams of milk protein per day for 8 weeks, 40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks.

Carbohydrate-soy protein-milk proteindietary

40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks.