Clinical Trial to Assess the Effects of Low-fat Dairy on Systolic Blood Pressure

Hypertension Clinical Trial

Official title:

A Randomized, Controlled, Trial to Assess the Effects of Low-fat Dairy Intake on Endothelial Function and Blood Pressure in Subjects With Pre-hypertension or Stage 1 Hypertension

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01463085
• Other study ID #: PRV-11022
• Status: Active, not recruiting
• Phase: N/A
• First received: October 27, 2011
• Last updated: May 23, 2012
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: May 2012
• Source: Dairy Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 69 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Low-fat dairy
Dietary Intervention of 3 servings per day of low-fat dairy

Locations

Country	Name	City	State
United States	Biofortis - Provident Clinical Research	Glen Ellyn	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Dairy Research Institute	BioFortis, Provident Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	Seated, resting blood pressure and heart rate will be measured by an automated blood pressure measurement device.	5 weeks	No
Secondary	Vascular function	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.	5 weeks	No