Protein Supplements to Treat High Blood Pressure
|Cardiovascular Diseases Hypertension Heart Diseases||Behavioral: Soy Protein Dietary Supplements Behavioral: Milk Protein Dietary Supplements Behavioral: Complex Carbohydrate Dietary Supplements||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
|Official Title:||Clinical Trial of Dietary Protein on Blood Pressure|
- Systolic and diastolic blood pressure [ Time Frame: Every 3 months ]
- Differences in fasting plasma insulin and glucose levels [ Time Frame: Every 3 months ]
- Differences in lipid, leptin and in homocysteine levels [ Time Frame: Every 3 months ]
- Waist and hip circumferences [ Time Frame: Every 3 months ]
|Study Start Date:||July 2002|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Participants will receive 40 grams of soy protein daily for 8 weeks.
Behavioral: Soy Protein Dietary Supplements
40 gram soy protein per day
Participants will receive 40 grams of milk protein daily for 8 weeks.
Behavioral: Milk Protein Dietary Supplements
40 grams of milk protein per day
Placebo Comparator: 3
Participants will receive 40 grams of complex carbohydrates (control) daily for 8 weeks.
Behavioral: Complex Carbohydrate Dietary Supplements
40 grams of carbohydrate per day
At least 50 million adult Americans have high BP, which is one of the most important modifiable risk factors for coronary heart disease, stroke, and end-stage kidney disease. Nutrient intake has been related to the development of high BP, and nutritional modifications have become an important approach for the treatment and prevention of high BP. While the effect of sodium, potassium, and alcohol on BP has been studied extensively, the effect of dietary macronutrients, such as protein, has not been as well studied. Results from this study may provide justification for recommending protein supplements for the prevention and treatment of high BP in the general population.
The study will enroll 280 healthy participants with BP levels higher than optimal or with stage-1 hypertension (systolic BP of 120-159 mm Hg and diastolic BP of 80-95 mm HG). Participants will be recruited by a mass mailing and a worksite/community-based BP screening in New Orleans, Louisiana, and Jackson, Mississippi. Following a two-week screening period, eligible participants will receive either 40 grams of soy protein, 40 grams of milk protein, or 40 grams of complex carbohydrates (control) daily for eight weeks. Following those eight weeks, participants will not receive any supplements for three weeks. Participants will then repeat the process with the other two supplements. The primary outcome will be difference in BP during the soy protein supplementation, milk protein supplementation, and placebo control phases. In addition, changes in serum lipids; waist and hip circumference; and fasting plasma insulin, glucose, leptin, and homocysteine will be monitored and examined in terms of impact on BP level.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046566
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70112|
|Study Chair:||Jiang He, MD||Tulane University|