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

NCT01411293 | Completed

• 1 other identifier: H11-124
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Metabolic Syndrome; Obesity

Keywords

cardiovascular disease; oxidative stress; dairy consumption; metabolic syndrome; obesity; endothelial function

Outcome Measures

Primary Outcomes (1)

• endothelial function

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

  3 hours

Secondary Outcomes (1)

• Biomarkers of oxidative stress and nitric oxide metabolism

  3 hours

Study Arms (2)

Low-Fat Dairy

EXPERIMENTAL

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

Other: Low-Fat Milk

Rice Milk

ACTIVE COMPARATOR

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

Other: Rice Milk

Interventions

Low-Fat Milk OTHER

Participants will ingest 2 cups of low-fat milk on 1 occasion.

Low-Fat Dairy

Rice Milk OTHER

Participants will ingest 2 cups of rice milk on 1 occasion.

Rice Milk

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related Publications (1)

• 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.

  PMID: 23966328 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Metabolic Syndrome; Obesity

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Richard S Bruno, PhD, RD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 8, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2013
• Last Updated: January 6, 2014

Record last verified: 2014-01

Locations

US (1)