Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Milk
4 maj 2019 uppdaterad av: 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.
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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
23
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ohio
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Columbus, Ohio, Förenta staterna, 43210
- The Ohio State University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 50 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: Glukos
Denna studiedag kommer att pågå i cirka tre timmar och kommer att separeras från de andra armarna med fyra dagar för män och en månad för kvinnor.
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Efter baslinjemätningar kommer deltagarna att konsumera en 75 g glukoslösning inom fem minuter.
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Experimentell: Glukos med fettfri mjölk
Denna studiedag kommer att pågå i cirka tre timmar och kommer att separeras från de andra armarna med fyra dagar för män och en månad för kvinnor.
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Efter baslinjemätningar kommer deltagarna att konsumera 75 g glukos löst i två koppar fettfri mjölk inom fem minuter.
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Experimentell: 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.
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Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.
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Experimentell: 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.
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Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Vascular Endothelial Function
Tidsram: Area under curve for FMD for three hours (0, 30, 60, 90, 120, 180 minutes)
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Flow mediated dilation (FMD) of the brachial artery, calculated as FMD AUC for 0-180 minutes (change from baseline)
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Area under curve for FMD for three hours (0, 30, 60, 90, 120, 180 minutes)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Nitrite/Nitrate (NOx)
Tidsram: Area under curve for nitrite/nitrate for three hours (0, 30, 60, 90, 120, 180 min) (change from baseline)
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NOx AUC for 0-180 minutes
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Area under curve for nitrite/nitrate for three hours (0, 30, 60, 90, 120, 180 min) (change from baseline)
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Plasma Glucose
Tidsram: Area under the curve for glucose for three hours (0, 30, 60, 90, 120, 180 minutes) (change from baseline)
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Plasma glucose concentration from 0-180 minutes
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Area under the curve for glucose for three hours (0, 30, 60, 90, 120, 180 minutes) (change from baseline)
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Malondialdehyde (MDA)
Tidsram: Area under curve for MDA for three hours (0, 30, 60, 90, 120, 150, 180 min.) (change from baseline)
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Plasma MDA measured as MDA AUC from 0-180 minutes
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Area under curve for MDA for three hours (0, 30, 60, 90, 120, 150, 180 min.) (change from baseline)
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Arginine (ARG)
Tidsram: ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma arginine concentration, calculated as ARG AUC from 0-180 minutes
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ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Asymmetric Dimethylarginine/Arginine (ADMA/ARG)
Tidsram: ADMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma ADMA/arginine concentration, calculated as ADMA/ARG AUC from 0-180 minutes
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ADMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Symmetric Dimethylarginine/Arginine (SDMA/ARG)
Tidsram: SDMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma SDMA/arginine concentration, calculated as SDMA/ARG AUC from 0-180 minutes
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SDMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Tetrahydrobiopterin/Dihydrobiopterin (BH4/BH2)
Tidsram: Plasma BH4/BH2 concentration area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma BH4/BH2 concentration, calculated as BH4/BH2 AUC from 0-180 minutes
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Plasma BH4/BH2 concentration area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Insulin
Tidsram: Insulin area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma insulin concentration, calculated as insulin AUC from 0-180 minutes
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Insulin area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Cholecystokinin (CCK)
Tidsram: CCK area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma CCK concentration, calculated as CCK AUC from 0-180 minutes
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CCK area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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8-isoprostaglandin-F2a
Tidsram: 8-isoprostaglandin-F2a area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma 8-isoprostaglandin-F2a concentration, calculated as 8-isoprostaglandin-F2a AUC from 0-180 minutes
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8-isoprostaglandin-F2a area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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8-isoprostaglandin-F2a/Arachidonic Acid
Tidsram: 8-isoprostaglandin-F2a/Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma 8-isoprostaglandin-F2a/Arachidonic acid concentration, calculated as 8-isoprostaglandin-F2a/Arachidonic acid AUC from 0-180 minutes
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8-isoprostaglandin-F2a/Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Arachidonic Acid
Tidsram: Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Arachidonic acid concentration, calculated as Arachidonic acid AUC from 0-180 minutes
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Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Richard S Bruno, PhD, RD, Ohio State University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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. Erratum In: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2015
Primärt slutförande (Faktisk)
1 juli 2016
Avslutad studie (Faktisk)
1 februari 2018
Studieregistreringsdatum
Först inskickad
24 juni 2015
Först inskickad som uppfyllde QC-kriterierna
24 juni 2015
Första postat (Uppskatta)
26 juni 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 maj 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 maj 2019
Senast verifierad
1 maj 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2015H0088
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Glukos
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