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

NCT ID: NCT02482675

Last Updated: 2019-05-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Glucose

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Glucose with Non-fat Milk

Intervention Type OTHER

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

Glucose with Whey Protein Isolate

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.

Group Type EXPERIMENTAL

Glucose with Whey Protein Isolate

Intervention Type OTHER

Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.

Glucose with Sodium Caseinate

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.

Group Type EXPERIMENTAL

Glucose with Sodium Caseinate

Intervention Type OTHER

Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes.

Interventions

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Glucose

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

Intervention Type 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.

Intervention Type OTHER

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.

Intervention Type OTHER

Glucose with Sodium Caseinate

Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Richard Bruno

Professor and Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard S Bruno, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25520374 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11176766 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26024056 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23966328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30412905 (View on PubMed)

Other Identifiers

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2015H0088

Identifier Type: -

Identifier Source: org_study_id

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