Hypertension Clinical Trial
Official title:
Clinical Trial of Dietary Protein on Blood Pressure
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
| Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
| Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
| Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
| Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
| Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
| Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
| Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
| Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
| Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
| Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
| Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
| Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
| Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
| Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
| Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
| Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |