Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Dairy Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
BioFortis
Provident Clinical Research
Information provided by (Responsible Party):
Dairy Research Institute
ClinicalTrials.gov Identifier:
NCT01463085
First received: October 27, 2011
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Hypertension
Other: Low-fat dairy

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

Resource links provided by NLM:


Further study details as provided by Dairy Research Institute:

Primary Outcome Measures:
  • Systolic blood pressure [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Seated, resting blood pressure and heart rate will be measured by an automated blood pressure measurement device.


Secondary Outcome Measures:
  • Vascular function [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 65
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control foods
3 servings per day of control foods
Other: Low-fat dairy
Dietary Intervention of 3 servings per day of low-fat dairy
Experimental: Low-fat dairy
3 servings per day of low-fat dairy products
Other: Low-fat dairy
Dietary Intervention of 3 servings per day of low-fat dairy

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463085

Locations
United States, Illinois
Biofortis - Provident Clinical Research
Glen Ellyn, Illinois, United States, 60137
Sponsors and Collaborators
Dairy Research Institute
BioFortis
Provident Clinical Research
Investigators
Study Director: Kevin C Maki, PhD Biofortis - Provident Clinical Research
  More Information

No publications provided

Responsible Party: Dairy Research Institute
ClinicalTrials.gov Identifier: NCT01463085     History of Changes
Other Study ID Numbers: PRV-11022
Study First Received: October 27, 2011
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014