Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046566
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2002-09-30
Brief Title:
Clinical Trial of Dietary Protein and Blood Pressure
Sponsor:
Tulane University
Organization:
Tulane University
Study Overview
Official Title:
Clinical Trial of Dietary Protein on Blood Pressure
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProBP
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 worksitecommunity-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
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 worksitecommunity-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL068057 | NIH | None | httpsreporternihgovquickSearchR01HL068057 |