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Completed

NCT Number: NCT02482610

Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Fat

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. Further controversial is the extent to which dietary fat derived from dairy foods regulate the risk of CVD. The health benefits of dairy on CVD risk are at least partly attributed to its ability to limit PPH and resulting PPH-mediated responses leading to vascular dysfunction. This provides rationale to investigate full-fat containing dairy as a dietary strategy to reduce PPH and risk for heart disease. The objective of this project is to define the extent to which full-fat dairy milk compared to non-fat dairy milk protects against PPH-induced vascular dysfunction by reducing oxidative stress responses that limit nitric oxide bioavailability to the vascular endothelium in adults with prediabetes.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

This study consists of three, 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, and 3. oral glucose challenge in combination with whole milk. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hemoglobin A1c 5.7-6.4%
  • non-dietary supplement user
  • no medications affecting vasodilation, inflammation, or energy metabolism
  • no CVD
  • nonsmokers
  • individuals having blood pressure <140/90 mmHg and total cholesterol <240 mg/dL

Exclusion criteria

  • unstable weight (±2 kg)
  • vegetarian or dairy allergy
  • alcohol intake >3 drinks/day or >10 drinks/week
  • ≥ 7 hours/week of aerobic activity

Treatment and study plan

Glucose

Other

Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.

Glucose with Whole Fat Milk

Other

Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of whole fat milk within five minutes.

Glucose with Non-fat Milk

Other

Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.

Primary outcomes

  1. Vascular Endothelial Function

    Time frame: Area under curve of FMD for three hours (0, 30, 60, 90, 120, 150, and 180 min)

    Flow mediated dilation (FMD) evaluated on the basis as change from baseline to calculate FMD area under the curve from 0-180 min, i.e. i.e. Area Under the Curve (AUC) of change from baseline in FMD from 0 min to 180 min (i.e., AUC (FMD 0 min- 0 min, FMD 30 min-0 min, FMD 60 min-0 min, etc)

Secondary outcomes

  1. Biomarker of Nitric Oxide Homeostasis (NOx)

    Time frame: Area under curve of nitrite/nitrate for three hours (0, 30, 60, 90, 120, 150, and 180 min)

    Biomarker of nitric oxide homeostasis is based on the assessment of total nitrite and nitrate concentrations. Changes relative to baseline were used to calculate area under the curve of total nitric oxide metabolites from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in nitric oxide homeostasis from 0 min to 180 min (i.e., AUC (NOx 0 min- 0 min, NOx 30 min-0 min, NOx 60 min-0 min, etc)

  2. Glucose

    Time frame: Area under curve of glucose for three hours (0, 30, 60, 90, 120, 150, and 180 min)

    Glucose concentrations evaluated on the basis as change from baseline to calculate glucose area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in glucose from 0 min to 180 min (i.e., AUC (glucose 0 min- 0 min, glucose 30 min-0 min, glucose 60 min-0 min, etc)

  3. Oxidative Stress Biomarker (Malondialdehyde; MDA)

    Time frame: Area under curve of MDA for three hours (0, 30, 60, 90, 120, 150, 180 min)

    MDA concentrations evaluated on the basis as change from baseline to calculate MDAarea under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in MDA from 0 min to 180 min (i.e., AUC (MDA 0 min- 0 min, MDA 30 min-0 min, MDA 60 min-0 min, etc)

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jun 26, 2015
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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