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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL068057 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to examine the effect of dietary protein supplements on high blood pressure (BP).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soy protein-milk protein-carbohydrate | Active Comparator | Participants received 40 grams of soy protein daily for 8 weeks, 40 grams of milk protein daily for 8 weeks, and 40 grams of carbohydrate daily for 8 weeks. |
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| Milk protein-carbohydrate-soy protein | Experimental | Participants received 40 grams of milk protein daily for 8 weeks, 40 grams of carbohydrate daily for 8 weeks, and 40 grams of soy protein daily for 8 weeks. |
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| Carbohydrate-soy protein-milk protein | Placebo Comparator | Participants received 40 grams of complex carbohydrate daily for 8 weeks, 40 grams of soy protein daily for 8 weeks, and 40 grams of milk protein daily for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soy protein-milk protein-carbohydrate | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Every 8 weeks |
| Body Weight at 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiang He, MD | Tulane University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15652604 | Background | Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005 Jan 15-21;365(9455):217-23. doi: 10.1016/S0140-6736(05)17741-1. | |
| 23187956 | Background | Rebholz CM, Reynolds K, Wofford MR, Chen J, Kelly TN, Mei H, Whelton PK, He J. Effect of soybean protein on novel cardiovascular disease risk factors: a randomized controlled trial. Eur J Clin Nutr. 2013 Jan;67(1):58-63. doi: 10.1038/ejcn.2012.186. Epub 2012 Nov 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Soy Protein-milk Protein-carbohydrate Group | 117 participants assigned to soy protein-milk protein-carbohydrate group. They received 40 g/d soy protein for 8 weeks, then 40 g/d milk protein for 8 weeks, and finally 40 g/d carbohydrate for 8 weeks. |
| FG001 | Milk Protein-carbohydrate-soy Protein Group | 117 participants assigned to milk protein-carbohydrate-soy protein group. They received 40 g/d milk protein for 8 weeks, then 40 g/d carbohydrate for 8 weeks, and finally 40 g/d soy protein for 8 weeks. |
| FG002 | Carbohydrate-soy Protein-milk Protein Group | 118 participants assigned to carbohydrate-soy protein-milk protein group. They received 40 g/d carbohydrate for 8 weeks, then 40 g/d soy protein for 8 weeks, and finally 40 g/d milk protein for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 (8 Weeks) |
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| Intervention 2 (8 Weeks) |
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| Intervention 3 (8 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Soy Protein-milk-protein-carbohydrate | Soy protein-milk-protein-carbohydrate group |
| BG001 | Milk Protein-carbohydrate-soy Protein | Milk protein-carbohydrate-soy protein group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | participants took soy protein during three phases | Posted | Mean | 95% Confidence Interval | mmHg | Every 8 weeks |
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From date of randomization until the date of study withdrawal or completion, whichever came first, assessed every 8 weeks, up to 24 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Soy Protein Supplementation | Cross-over analysis of soy protein supplementation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jiang He, MD, PhD, Chair of Epidemiology | Tulane University | 5049885165 | 504 | jhe@tulane.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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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.
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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.
| Milk protein-carbohydrate-soy protein | Dietary Supplement | 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. |
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| Carbohydrate-soy protein-milk protein | Behavioral | 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, |
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Body weight was measured by trained staff using a standard protocol at week 8. |
| Every 8 weeks |
| 21768541 | Result | He J, Wofford MR, Reynolds K, Chen J, Chen CS, Myers L, Minor DL, Elmer PJ, Jones DW, Whelton PK. Effect of dietary protein supplementation on blood pressure: a randomized, controlled trial. Circulation. 2011 Aug 2;124(5):589-95. doi: 10.1161/CIRCULATIONAHA.110.009159. Epub 2011 Jul 18. |
| 21952693 | Result | Wofford MR, Rebholz CM, Reynolds K, Chen J, Chen CS, Myers L, Xu J, Jones DW, Whelton PK, He J. Effect of soy and milk protein supplementation on serum lipid levels: a randomized controlled trial. Eur J Clin Nutr. 2012 Apr;66(4):419-25. doi: 10.1038/ejcn.2011.168. Epub 2011 Sep 28. |
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| NOT COMPLETED |
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| BG002 | Carbohydrate-soy Protein-milk Protein | Carbohydrate-soy protein-milk protein group |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Milk Protein Supplementation | Cross-over analysis of milk protein supplementation |
| OG002 | Carbohydrate Supplementation | Cross-over analysis of milk protein supplementation |
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| 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. | Participants took soy protein for 8 weeks | Posted | Mean | 95% Confidence Interval | mg/dL | Every 8 weeks |
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| Secondary | Body Weight at 8 Weeks | Body weight was measured by trained staff using a standard protocol at week 8. | Participants took supplementation for 8 weeks | Posted | Mean | 95% Confidence Interval | kg | Every 8 weeks |
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| 0 |
| 284 |
| 0 |
| 284 |
| 0 |
| 284 |
| EG001 | Milk Protein Supplementation | Cross-over analysis of milk protein supplementation | 0 | 286 | 0 | 286 | 0 | 286 |
| EG002 | Carbohydrate Supplementation | Cross-over analysis carbohydrate supplementation | 0 | 287 | 0 | 287 | 0 | 287 |
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