Hypertension
Conditions
Brief summary
The purpose of this study is to determine if increased consumption of low-fat dairy can reduce blood pressure and improve endothelial function in men and women with pre or stage-1 hypertension.
Interventions
OTHERLow-fat dairy
Dietary Intervention of 3 servings per day of low-fat dairy
Sponsors
BioFortis
Provident Clinical Research
Dairy Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Subject is a female or male, 20-69 years of age, inclusive. * Subject has a BMI of 18.5 to 39.9 kg/m2, inclusive. * Subject has resting blood pressure measurements meeting the criteria for pre-hypertension (SBP = 120 to 139 mm Hg and/or DBP = 80 to 89 mm Hg) or stage 1 hypertension (SBP = 140 to 159 mm Hg or DBP = 90 to 99 mm Hg) * Subject reports history of consuming, on average, ≤2 servings/d of dairy foods as part of their normal diet * Subject is willing to consume ≤1 serving/d of dairy foods (other than the study products provided) during each treatment phase. * Subject is willing to maintain a stable body weight and habitual diet and physical activity patterns throughout the trial, with the exception of specific study instructions related to study product intake, alcohol intake, and physical activity.
Exclusion criteria
* Subject has known coronary heart disease (CHD) or a CHD risk equivalent * Subject has a history of any major trauma or major surgical event * Subject has digital deformities that would prevent EndoPAT measurements. * Subject has used medications known to alter body weight * Subject has used medications or dietary supplements that, in the opinion of the Investigator, have strong potential to influence blood pressure or endothelial function * Subject has extreme dietary habits (e.g., Atkins diet, very high protein/low carbohydrate).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | 5 weeks | Seated, resting blood pressure and heart rate will be measured by an automated blood pressure measurement device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vascular function | 5 weeks | Subjects will be fasted overnight and endothelial function will be determined using the EndoPAT System according to the manufacturer's instructions. The measurements will occur in the index fingers of both hands, simultaneously and will be taken with subjects in a sitting position while in a quiet, thermo- neutral room. |
Countries
United States
Outcome results
None listed