High Blood Pressure Clinical Trial
Official title:
Effect of Whey Protein on Blood Pressure
The purpose of this study is to determine if consumption of whey protein, compared with soy protein or a carbohydrate food decreases blood pressure along with reducing risk factors for heart disease.
Status | Completed |
Enrollment | 35 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 28 Years to 70 Years |
Eligibility |
Inclusion Criteria: - BMI between 25 and 42 kg/m2 - Fasting glucose < 126 mg/dl - Blood pressure > 120/80 and < 160/100 mm Hg [based two measurements collected on separate days] Exclusion Criteria: - Use of prescription or over-the-counter medications that alter blood pressure. - Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes. - Women who have given birth during the previous 12 months. - Pregnant women or women who plan to become pregnant or become pregnant during the study. - Lactating women. - Type 2 diabetes requiring the use of oral antidiabetic agents or insulin. - History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets). - Volunteers who routinely participate in "heavy" exercise or volunteers who initiate an exercise program during the study. - Volunteers who have lost 10% of body weight within the last 12 months. - Use of vitamin and mineral supplements or antacids containing magnesium or calcium. - Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity. - Active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months). - Smokers or other tobacco users (during the 6 months prior to the start of the study). - Known (self-reported) allergy or adverse reaction to dairy products (including lactose) or soy. - Unable or unwilling to give informed consent or communicate with study staff. - Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion.) - Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | USDA Beltsville Human Nutrition Research Center | Beltsville | Maryland |
Lead Sponsor | Collaborator |
---|---|
United States Department of Agriculture (USDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | systolic and diastolic blood pressure | monthly | No | |
Secondary | Hormones,lipoproteins, and inflammation | monthly | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03812614 -
Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
|
N/A | |
Completed |
NCT03650166 -
High BP and Home Monitoring Experience (HoME) Study
|
N/A | |
Recruiting |
NCT02908139 -
Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients
|
N/A | |
Completed |
NCT01622400 -
Efficacy of a Dedicated Therapeutic Education Program in Patients at High Cardiovascular Risk
|
N/A | |
Completed |
NCT00473681 -
Intervention Study to Control High Blood Pressure for Korean American
|
N/A | |
Completed |
NCT03542240 -
Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome
|
N/A | |
Active, not recruiting |
NCT05526092 -
OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals
|
N/A | |
Completed |
NCT02218931 -
ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes
|
N/A | |
Recruiting |
NCT03753204 -
Salt-Sensitivity and Immunity Cell Activation
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04064281 -
The Healthy Cantonese Diet on Cardiometabolic Syndrome
|
N/A | |
Completed |
NCT04479384 -
The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study.
|
N/A | |
Completed |
NCT04082819 -
MediBeat - HeartBeat Observation Trial
|
N/A | |
Completed |
NCT03555344 -
Effect of Mantra on Hypertensive Patients
|
N/A | |
Withdrawn |
NCT03319823 -
Treating Nocturnal Hypertension and Nocturia in African American Men
|
Phase 4 | |
Completed |
NCT00689819 -
Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients
|
N/A | |
Completed |
NCT00417170 -
Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome
|
Phase 2 | |
Completed |
NCT00130156 -
Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension
|
Phase 4 | |
Completed |
NCT05808556 -
Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure
|
N/A | |
Recruiting |
NCT05321368 -
A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
|
N/A | |
Not yet recruiting |
NCT03686657 -
Evaluation of Superiority of Valsartan+Celecoxib+Metformin Over Metformin Alone in Type 2 Diabetes Patients
|
Phase 1/Phase 2 |