Cardiovascular Diseases, Heart Diseases, Hypertension
Conditions
Brief summary
The purpose of this study is to examine the effect of dietary protein supplements on high blood pressure (BP).
Detailed description
BACKGROUND: 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. DESIGN NARRATIVE: 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.
Interventions
DIETARY_SUPPLEMENTSoy protein-milk protein-carbohydrate
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
DIETARY_SUPPLEMENTMilk protein-carbohydrate-soy protein
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.
BEHAVIORALCarbohydrate-soy protein-milk protein
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,
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Tulane University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The randomization assignment list was generated by a computer program that could only be accessed by the study data coordinator. Apart from the data coordinator, all research personnel, including study coordinators and BP technicians, and the study participants were unaware of treatment assignment.
Intervention model description
The trial participants were assigned to take 40 g/d soy protein, milk protein, or carbohydrate supplementation each for 8 weeks in a random order. A 3-week washout period was implemented between the interventions.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Systolic Blood Pressure at 8 Weeks | Every 8 weeks | The change of systolic blood pressure was calculated as the mean of 6 blood pressure values from two 8-week visits minus the mean of 6 values from two baseline visits within each intervention phase. At each visit, 3 BP values were measured with a Hawksley random-zero sphygmomanometer by trained and certified observers who were masked to group assignment. BP readings were taken from the right arm with appropriately sized cuffs after the participant had been seated quietly for 5 minutes. The participant was instructed not to eat, smoke, drink alcohol, or exercise for at least 30 minutes before their BP measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Serum LDL-cholesterol at 8 Weeks | Every 8 weeks | Change in serum LDL-cholesterol was calculated as LDL-cholesterol at 8 weeks minus LDL-cholesterol at baseline. Over-night fasting serum LDL-cholesterol was measured with an enzymatic method. |
| Body Weight at 8 Weeks | Every 8 weeks | Body weight was measured by trained staff using a standard protocol at week 8. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Soy Protein-milk-protein-carbohydrate Soy protein-milk-protein-carbohydrate group | 117 |
| Milk Protein-carbohydrate-soy Protein Milk protein-carbohydrate-soy protein group | 117 |
| Carbohydrate-soy Protein-milk Protein Carbohydrate-soy protein-milk protein group | 118 |
| Total | 352 |
Baseline characteristics
| Characteristic | Soy Protein-milk-protein-carbohydrate | Milk Protein-carbohydrate-soy Protein | Carbohydrate-soy Protein-milk Protein | Total |
|---|---|---|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 11.5 | 46.7 years STANDARD_DEVIATION 10.7 | 48.1 years STANDARD_DEVIATION 8.7 | 47.7 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 117 participants | 117 participants | 118 participants | 352 participants |
| Sex: Female, Male Female | 69 Participants | 68 Participants | 68 Participants | 205 Participants |
| Sex: Female, Male Male | 48 Participants | 49 Participants | 50 Participants | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 284 | 0 / 286 | 0 / 287 |
| other Total, other adverse events | 0 / 284 | 0 / 286 | 0 / 287 |
| serious Total, serious adverse events | 0 / 284 | 0 / 286 | 0 / 287 |
Outcome results
Primary
Change From Baseline in Average Systolic Blood Pressure at 8 Weeks
The change of systolic blood pressure was calculated as the mean of 6 blood pressure values from two 8-week visits minus the mean of 6 values from two baseline visits within each intervention phase. At each visit, 3 BP values were measured with a Hawksley random-zero sphygmomanometer by trained and certified observers who were masked to group assignment. BP readings were taken from the right arm with appropriately sized cuffs after the participant had been seated quietly for 5 minutes. The participant was instructed not to eat, smoke, drink alcohol, or exercise for at least 30 minutes before their BP measurements.
Time frame: Every 8 weeks
Population: participants took soy protein during three phases
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Soy Protein Supplementation | Change From Baseline in Average Systolic Blood Pressure at 8 Weeks | -1.5 mmHg |
| Milk Protein Supplementation | Change From Baseline in Average Systolic Blood Pressure at 8 Weeks | -1.8 mmHg |
| Carbohydrate Supplementation | Change From Baseline in Average Systolic Blood Pressure at 8 Weeks | 0.5 mmHg |
Secondary
Body Weight at 8 Weeks
Body weight was measured by trained staff using a standard protocol at week 8.
Time frame: Every 8 weeks
Population: Participants took supplementation for 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Soy Protein Supplementation | Body Weight at 8 Weeks | 86.2 kg |
| Milk Protein Supplementation | Body Weight at 8 Weeks | 86.6 kg |
| Carbohydrate Supplementation | Body Weight at 8 Weeks | 86.7 kg |
Secondary
Change From Baseline in Serum LDL-cholesterol at 8 Weeks
Change in serum LDL-cholesterol was calculated as LDL-cholesterol at 8 weeks minus LDL-cholesterol at baseline. Over-night fasting serum LDL-cholesterol was measured with an enzymatic method.
Time frame: Every 8 weeks
Population: Participants took soy protein for 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Soy Protein Supplementation | Change From Baseline in Serum LDL-cholesterol at 8 Weeks | -3.97 mg/dL |
| Milk Protein Supplementation | Change From Baseline in Serum LDL-cholesterol at 8 Weeks | -2.56 mg/dL |
| Carbohydrate Supplementation | Change From Baseline in Serum LDL-cholesterol at 8 Weeks | -1.41 mg/dL |