N/A
N=352
Clinical Trial of Protein and Blood Pressure
Hypertension · Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00107744 ↗Enrolled (actual)
352
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Change From Baseline in Average Systolic Blood Pressure at 8 Weeks — -1.5; -1.8; 0.5 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Soy protein-milk protein-carbohydrate (Dietary_supplement); Milk protein-carbohydrate-soy protein (Dietary_supplement); Carbohydrate-soy protein-milk protein (Dietary_supplement)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Tulane University
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Systolic Blood Pressure at 8 Weeks |
-1.5; -1.8; 0.5 | — |
| SECONDARY Change From Baseline in Serum LDL-cholesterol at 8 Weeks |
-3.97; -2.56; -1.41 | — |
| SECONDARY Body Weight at 8 Weeks |
86.2; 86.6; 86.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Systolic BP of 120 to 159 mm Hg and diastolic BP of 80 to 95 mm Hg (average of 6 measurements at 2 screening visits)
- Willing to participate in all aspects of the study
Exclusion Criteria
- Consumption of dietary protein greater than or equal to 1.63 grams/kg per day, as determined by two 24-hour dietary recalls
- Stage-2 or higher severe hypertension (systolic BP greater than or equal to 160 mm Hg and/or diastolic BP greater than or equal to 95 mm Hg)
- Use of antihypertensive medications or medications that affect BP
- History of clinical heart disease (e.g., angina/heart attack, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease)
- Kidney disease (serum creatinine level greater than or equal to 1.7 mg/dL for men and greater than or equal to 1.5 mg/dL for women)
- Current hypercholesterolemia (fasting serum total cholesterol greater than or equal to 240 mg/dL) or use of cholesterol-lowering medications
- Current diabetes (fasting serum glucose greater than or equal to 126 mg/dL) or use of insulin or oral hypoglycemic agents
- Severe obesity (body mass index greater than or equal to 40 kg/m²)
- Current use of prescription weight loss medications, underwent weight loss surgery, and/or experienced weight loss greater than 15 pounds within the 6 months prior to study entry
- Cancer (except non-melanoma skin cancer) that required treatment during the year prior to study entry
- Consumption of more than 14 alcoholic beverages per week
- Current participation in another medical study
- Consumption of milk or soy protein greater than or equal to the 90th percentile of intake in the U.S. general population
- Has another member of the household participating in the study
- Study employees or living with study employees
- Allergy or intolerance to soy protein or milk protein products
- Allergy to aspartame
- Plans to move out of the study area (greater than or equal to 50 miles from the study site) and has difficulty coming to the study site
- Inability or unwillingness to cooperate during the screening visits
- Poor compliance during the screening period (intake of less than 85% of supplements)
- Pregnant or plans to become pregnant during the study
Data sourced from ClinicalTrials.gov (NCT00107744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.