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 for 8 weeks, 40 grams of milk protein per day for 8 weeks, and 40 grams of carbohydrate per day for 8 weeks (in rotating sequences)AI-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· 13
  • ✕Baseline dietary protein intake ≥1.63 g/kg/day (by 24-hour dietary recall)
  • ✕Stage 2+ hypertension (systolic ≥160 mm Hg or diastolic ≥95 mm Hg)
  • ✕Current use of antihypertensive medications or medications affecting blood pressure
  • ✕History of clinical heart disease (angina, MI, revascularization, heart failure, stroke, TIA, PAD)

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

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NCT00046566N/ACompleted
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Clinical Trial of Dietary Protein on Blood Pressure

Tulane University·interventional·Posted Oct 1, 2002·Updated Jul 24, 2017

In Brief

A clinical study evaluating Soy protein-milk protein-carbohydrate, Milk protein-carbohydrate-soy protein, and 1 other intervention for Cardiovascular Diseases and 2 related conditions. Completed, enrolled 352 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the effect of dietary protein supplements on high blood pressure (BP).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Diseases, Hypertension, Heart Diseases
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 1, 2002
Enrollment StartJul 1, 2002
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 23.8 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 proteinbehavioral

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,