Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107744
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2005-04-07
Brief Title:
Clinical Trial of Protein and Blood Pressure
Sponsor:
Tulane University
Organization:
Tulane University
Study Overview
Official Title:
Clinical Trial of Protein and Blood Pressure
Status:
COMPLETED
Status Verified Date:
2018-06
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 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
Detailed Description:
Background Epidemiologic studies suggest that vegetable protein intake is inversely related to blood pressure
Objectives To examine the effect of soybean protein supplementation on blood pressure in persons with prehypertension or stage-1 hypertension
Design Randomized double-blind controlled trial
Study Participants 350 participants aged 35-64 years with an initial untreated systolic blood pressure of 130-159 mmHg andor diastolic blood pressure of 80-99 mmHg
Intervention Study participants will be randomly assigned to take 40-grams of isolated soybean protein supplements per day or complex carbohydrate control for 12 weeks
Outcomes Blood pressure measurements will be obtained using random-zero sphygmomanometers at baseline and during the trial at weeks 6 and 12 Net changes in systolic and diastolic blood pressure before and after the intervention is the primary outcome
Objectives To examine the effect of soybean protein supplementation on blood pressure in persons with prehypertension or stage-1 hypertension
Design Randomized double-blind controlled trial
Study Participants 350 participants aged 35-64 years with an initial untreated systolic blood pressure of 130-159 mmHg andor diastolic blood pressure of 80-99 mmHg
Intervention Study participants will be randomly assigned to take 40-grams of isolated soybean protein supplements per day or complex carbohydrate control for 12 weeks
Outcomes Blood pressure measurements will be obtained using random-zero sphygmomanometers at baseline and during the trial at weeks 6 and 12 Net changes in systolic and diastolic blood pressure before and after the intervention is the primary outcome
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 |