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

April 2, 2019 updated by: Richard Bruno, Ohio State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glucose
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.
Other: Glucose
Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.
Experimental: Glucose with Whole Fat Milk
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.
Other: Glucose with Whole Fat Milk
Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of whole fat milk within five minutes.
Experimental: Glucose with Non-fat Milk
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Area under curve of FMD for three hours (0, 30, 60, 90, 120, 150, and 180 min)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Area under curve of nitrite/nitrate for three hours (0, 30, 60, 90, 120, 150, and 180 min)
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)
Area under curve of glucose for three hours (0, 30, 60, 90, 120, 150, and 180 min)
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)
Area under curve of MDA for three hours (0, 30, 60, 90, 120, 150, 180 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Richard S Bruno, PhD, RD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015H0088B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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