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Vasoprotective Activities of Low-Fat Milk in Individuals With Metabolic Syndrome

Primary Purpose

Cardiovascular Disease, Metabolic Syndrome, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Fat Milk
Rice Milk
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiovascular Disease focused on measuring cardiovascular disease, oxidative stress, dairy consumption, metabolic syndrome, obesity, endothelial function

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • specific criteria of the metabolic syndrome (waist circumference (102-137 or 88-123 cm for men and women, respectively), fasting triglycerides 150-300 mg/dL, and fasting glucose (110-180 mg/dL)
  • BMI: >30 kg/m2,
  • non-dietary supplement users for >2-mo
  • no use of any prescription or over-the-counter medications known to affect vasodilatory responses
  • no known history of vascular disease
  • nonsmokers
  • resting blood pressure <140 mmHg
  • not taking any medications that control hypertension

Exclusion Criteria:

  • lactose-intolerant
  • excessive alcohol consumption (>3 drinks/d or >10 drinks/wk)
  • >7 h/wk of aerobic activity
  • use of medications known to affect carbohydrate or lipid/lipoprotein metabolism
  • regular use of any anti-inflammatory medications (e.g. aspirin, non-steroidal anti-inflammatory drugs) or over-the-counter aids (e.g. fish oils)
  • women who are pregnant, lactating, and have initiated or changed birth control in the past 3-mo

Sites / Locations

  • University of Connecticut

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-Fat Dairy

Rice Milk

Arm Description

Participants will ingest 2 cups of low-fat milk on 1 occasion prior to measure postprandial changes in vascular function

Participants will ingest 2 cups of rice milk on 1 ocassion prior to measuring postprandial vascular function

Outcomes

Primary Outcome Measures

endothelial function
Brachial artery flow-mediated dilation will be assessed at 30 min intervals during a 3 hour postprandial period

Secondary Outcome Measures

Biomarkers of oxidative stress and nitric oxide metabolism
At 30 min intervals throughout a 3 hour postprandial period, biomarkers of oxidative stress (glutathione, malondialdehyde, nitrotyrosine, and antioxidants) as well as nitric oxide metabolism (arginine, asymmetric dimethylarginine, and nitric oxide metabolites) will be evaluated.

Full Information

First Posted
August 4, 2011
Last Updated
January 3, 2014
Sponsor
University of Connecticut
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1. Study Identification

Unique Protocol Identification Number
NCT01411293
Brief Title
Vasoprotective Activities of Low-Fat Milk in Individuals With Metabolic Syndrome
Official Title
Vasoprotective Activities of Low-Fat Milk in Individuals With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to define whether the acute consumption of low-fat milk protects against postprandial vascular endothelial dysfunction by reducing oxidative stress responses that limit nitric oxide bioavailability to the vascular endothelium. The investigators hypothesis is that the consumption of low-fat milk will improve postprandial vascular endothelial function in an oxidative stress-dependent manner that allows greater nitric oxide (NO) bioavailability. The objectives of this study are to 1) examine improvements in postprandial vascular endothelial function in response to low-fat milk ingestion, 2) define low-fat milk-mediated improvements in circulating biomarkers of redox status, and 3) define the mechanism by which low-fat milk improves NO bioavailability. Collectively, the successful completion of these studies is expected to define NO mediated activities of low-fat milk that protect against vascular endothelial dysfunction in individuals at high risk for developing CVD.
Detailed Description
Cardiovascular disease (CVD) is the leading cause of death in the United States, accounting for ~830,000 deaths annually. Oxidative stress and inflammatory responses are fundamental mechanisms leading to vascular endothelial dysfunction because of their role in reducing nitric oxide (NO) bioavailability. Greater intakes of dairy foods have been associated with a lower incidence of CVD-related morbidity. Although the mechanisms by which dairy protects against CVD remain unclear, epidemiological and experimental evidence suggest that the concerted actions of bioactive milk-derived peptides and micronutrients may protect against hypertension and future CVD risk by improving vascular endothelial function. Therefore, the objective of this study is to define the mechanisms by which the acute consumption of low-fat milk protects against postprandial vascular endothelial dysfunction by reducing oxidative stress responses that limit NO bioavailability to the vascular endothelium. In this study, participants having the metabolic syndrome will ingest low-fat milk or rice milk on a single occasion. Then, vascular function and biomarkers of oxidative stress and NO metabolism will be monitored at 30 min intervals throughout a 180 min postprandial period. Collectively, these studies will help identify how postprandial vascular function is regulated in individuals at high-risk for CVD, and whether low-fat dairy consumption can be used as a strategy to better improve vascular function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Metabolic Syndrome, Obesity
Keywords
cardiovascular disease, oxidative stress, dairy consumption, metabolic syndrome, obesity, endothelial function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-Fat Dairy
Arm Type
Experimental
Arm Description
Participants will ingest 2 cups of low-fat milk on 1 occasion prior to measure postprandial changes in vascular function
Arm Title
Rice Milk
Arm Type
Active Comparator
Arm Description
Participants will ingest 2 cups of rice milk on 1 ocassion prior to measuring postprandial vascular function
Intervention Type
Other
Intervention Name(s)
Low-Fat Milk
Intervention Description
Participants will ingest 2 cups of low-fat milk on 1 occasion.
Intervention Type
Other
Intervention Name(s)
Rice Milk
Intervention Description
Participants will ingest 2 cups of rice milk on 1 occasion.
Primary Outcome Measure Information:
Title
endothelial function
Description
Brachial artery flow-mediated dilation will be assessed at 30 min intervals during a 3 hour postprandial period
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Biomarkers of oxidative stress and nitric oxide metabolism
Description
At 30 min intervals throughout a 3 hour postprandial period, biomarkers of oxidative stress (glutathione, malondialdehyde, nitrotyrosine, and antioxidants) as well as nitric oxide metabolism (arginine, asymmetric dimethylarginine, and nitric oxide metabolites) will be evaluated.
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: specific criteria of the metabolic syndrome (waist circumference (102-137 or 88-123 cm for men and women, respectively), fasting triglycerides 150-300 mg/dL, and fasting glucose (110-180 mg/dL) BMI: >30 kg/m2, non-dietary supplement users for >2-mo no use of any prescription or over-the-counter medications known to affect vasodilatory responses no known history of vascular disease nonsmokers resting blood pressure <140 mmHg not taking any medications that control hypertension Exclusion Criteria: lactose-intolerant excessive alcohol consumption (>3 drinks/d or >10 drinks/wk) >7 h/wk of aerobic activity use of medications known to affect carbohydrate or lipid/lipoprotein metabolism regular use of any anti-inflammatory medications (e.g. aspirin, non-steroidal anti-inflammatory drugs) or over-the-counter aids (e.g. fish oils) women who are pregnant, lactating, and have initiated or changed birth control in the past 3-mo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard S Bruno, PhD, RD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23966328
Citation
Ballard KD, Mah E, Guo Y, Pei R, Volek JS, Bruno RS. Low-fat milk ingestion prevents postprandial hyperglycemia-mediated impairments in vascular endothelial function in obese individuals with metabolic syndrome. J Nutr. 2013 Oct;143(10):1602-10. doi: 10.3945/jn.113.179465. Epub 2013 Aug 21.
Results Reference
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Vasoprotective Activities of Low-Fat Milk in Individuals With Metabolic Syndrome

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