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

NCT02482610 | Completed Results

• 1 other identifier: 2015H0088B
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetes

Keywords

Dairy; Milk; Glucose; Postprandial; Hyperglycemia; Prediabetes; Blood glucose; Oxidative stress; Vascular health; Vascular function

Outcome Measures

Primary Outcomes (1)

• Vascular Endothelial Function

  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 Outcomes (3)

• Biomarker of Nitric Oxide Homeostasis (NOx)

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

• Glucose

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

• Oxidative Stress Biomarker (Malondialdehyde; MDA)

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

Study Arms (3)

Glucose

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.

Other: Glucose

Glucose with Whole Fat Milk

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.

Other: Glucose with Whole Fat Milk

Glucose with Non-fat Milk

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.

Other: Glucose with Non-fat Milk

Interventions

Glucose OTHER

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

Glucose

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 Whole Fat Milk

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.

Glucose with Non-fat Milk

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (5)

• Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres 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. No abstract available.

  PMID: 25520374 BACKGROUND

• DECODE Study Group, the European Diabetes Epidemiology Group.. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch Intern Med. 2001 Feb 12;161(3):397-405. doi: 10.1001/archinte.161.3.397.

  PMID: 11176766 BACKGROUND

• Ballard KD, Bruno RS. Protective role of dairy and its constituents on vascular function independent of blood pressure-lowering activities. Nutr Rev. 2015 Jan;73(1):36-50. doi: 10.1093/nutrit/nuu013.

  PMID: 26024056 BACKGROUND

• 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 BACKGROUND

• McDonald JD, Mah E, Chitchumroonchokchai C, Dey P, Labyk AN, Villamena FA, Volek JS, Bruno RS. Dairy milk proteins attenuate hyperglycemia-induced impairments in vascular endothelial function in adults with prediabetes by limiting increases in glycemia and oxidative stress that reduce nitric oxide bioavailability. J Nutr Biochem. 2019 Jan;63:165-176. doi: 10.1016/j.jnutbio.2018.09.018. Epub 2018 Sep 25.

  PMID: 30412905 RESULT

MeSH Terms

Conditions

Prediabetic State; Hyperglycemia

Interventions

Glucose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Results Point of Contact

• Title: Richard Bruno, PhD, RD
• Organization: The Ohio State University

bruno.27@osu.edu

6142925522

Study Officials

• Richard S Bruno, PhD, RD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Principal Investigator

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: June 26, 2015
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: March 1, 2018
• Last Updated: April 29, 2019
• Results First Posted: April 29, 2019

Record last verified: 2019-04

Locations

US (1)