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

NCT01463085 | Unknown

• 1 other identifier: PRV-11022
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure

  Seated, resting blood pressure and heart rate will be measured by an automated blood pressure measurement device.

  5 weeks

Secondary Outcomes (1)

• Vascular function

  5 weeks

Study Arms (2)

Control foods

PLACEBO COMPARATOR

3 servings per day of control foods

Other: Low-fat dairy

Low-fat dairy

EXPERIMENTAL

3 servings per day of low-fat dairy products

Other: Low-fat dairy

Interventions

Low-fat dairy OTHER

Dietary Intervention of 3 servings per day of low-fat dairy

Control foods; Low-fat dairy

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dairy Research Institute: lead
• BioFortis: collaborator
• Provident Clinical Research: collaborator

Study Sites (1)

Biofortis - Provident Clinical Research

Glen Ellyn, Illinois, 60137, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kevin C Maki, PhD

  Biofortis - Provident Clinical Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 1, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 24, 2012

Record last verified: 2012-05

Locations

US (1)