Clinical Trial to Assess the Effects of Low-fat Dairy on... | NCT01463085

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

NCT01463085

Sponsor

Dairy Research Institute

Status

Unknown status

Last Update Posted

May 24, 2012Estimated

Enrollment

65Estimated

Phase

Not Applicable

Conditions

Hypertension

Interventions

Low-fat dairy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Aug 2012Estimated

Completion Date

Aug 2012Estimated

First Submitted Date

Oct 27, 2011

First Submission Date that Met QC Criteria

Oct 28, 2011

First Posted Date

Nov 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2012

Last Update Posted Date

May 24, 2012Estimated

Name	Class
BioFortis	OTHER
Provident Clinical Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Low-fat dairy	Other	Dietary Intervention of 3 servings per day of low-fat dairy	Control foods Low-fat dairy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Systolic blood pressure	Seated, resting blood pressure and heart rate will be measured by an automated blood pressure measurement device.	5 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases