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Trial record 57 of 729 for:    Area Under Curve AND Bioavailability

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

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ClinicalTrials.gov Identifier: NCT02482610
Recruitment Status : Completed
First Posted : June 26, 2015
Results First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Richard Bruno, Ohio State University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Prediabetes Other: Glucose Other: Glucose with Whole Fat Milk Other: Glucose with Non-fat Milk Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Fat
Actual Study Start Date : June 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482610


Locations
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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Richard S Bruno, PhD, RD Ohio State University
  Study Documents (Full-Text)

Documents provided by Richard Bruno, Ohio State University:

Publications of Results:
Other Publications:
Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. Erratum in: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417.

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Responsible Party: Richard Bruno, Professor and Principal Investigator, Ohio State University
ClinicalTrials.gov Identifier: NCT02482610     History of Changes
Other Study ID Numbers: 2015H0088B
First Posted: June 26, 2015    Key Record Dates
Results First Posted: April 29, 2019
Last Update Posted: April 29, 2019
Last Verified: April 2019
Keywords provided by Richard Bruno, Ohio State University:
Dairy
Milk
Glucose
Postprandial
Hyperglycemia
Prediabetes
Blood glucose
Oxidative stress
Vascular health
Vascular function
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents