Overview

This trial is active, not recruiting.

Condition prediabetes
Treatments glucose, glucose with non-fat milk, glucose with whey protein isolate, glucose with sodium caseinate
Sponsor Ohio State University
Start date June 2015
End date January 2017
Trial size 24 participants
Trial identifier NCT02482675, 2015H0088

Summary

Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function and increase the risk of CVD. Greater intakes of dairy foods have been associated with a lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods in the diet that might increase CVD risk is unclear. The health benefits of dairy on heart health are at least partly attributed to its ability to limit PPH and resulting PPH-mediated responses leading to vascular dysfunction. This provides rationale to further investigate dairy as a dietary strategy to reduce PPH and risk for CVD. The objective of this study is to define the extent to which dairy milk, and its whey and casein protein fractions, protect against postprandial vascular dysfunction by reducing oxidative stress responses that limit nitric oxide bioavailability to the vascular endothelium in adults with prediabetes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.
glucose
Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.
(Experimental)
This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.
glucose with non-fat milk
Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.
(Experimental)
This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.
glucose with whey protein isolate
Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.
(Experimental)
This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.
glucose with sodium caseinate
Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes.

Primary Outcomes

Measure
Vascular Endothelial Function
time frame: Three hours

Secondary Outcomes

Measure
Biomarkers of vascular function
time frame: Three hours
Clinical Chemistries
time frame: Three hours
Oxidative Stress
time frame: Three hours
Covariates
time frame: Baseline

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: 1. hemoglobin A1c 5.7-6.4% 2. non-dietary supplement user 3. no medications affecting vasodilation, inflammation, or energy metabolism 4. no CVD 5. nonsmokers 6. individuals having blood pressure <140/90 mmHg and total cholesterol <240 mg/dL Exclusion Criteria: 1. unstable weight (±2 kg) 2. vegetarian or dairy allergy 3. alcohol intake >3 drinks/day or >10 drinks/week 4. ≥7 hours/week of aerobic activity

Additional Information

Official title Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Milk
Principal investigator Richard S Bruno, PhD, RD
Description This study consists of four, 3-hour postprandial trials in response to consuming the following dietary treatments: 1. oral glucose challenge, 2. oral glucose challenge in combination with non-fat milk, 3. oral glucose challenge in combination with whey protein isolate, and 4. oral glucose challenge in combination with sodium caseinate. For three days preceding each trial, participants will be provided all meals to standardize physiologic responses to test meals. On each trial day, vascular function will be assessed and blood samples collected prior to and at 30 minute intervals for 3 hours following test meal ingestion.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Ohio State University.