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The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones

27. november 2017 opdateret af: Seoul National University Hospital

The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones in Healthy Adults and Patients With Type 2 Diabetes

The aim of this study is to explore premeal protein-enriched bar effect in postprandial glucose levels and concentration of plasma incretin hormones [glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP)] in healthy subjects and those with type 2 diabetes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Fifteen healthy subjects and fifteen subjects with type 2 diabetes treated by diet and/or metformin, SU, DPP4 inhibitors will be recruited. Every subject will studied on 2 separate days in random order with 1-2 week intervals. These participants will consume protein enriched bar followed by a standardized high-glycemic-index breakfast in a hospital setting or breakfast followed protein enriched bar in a cross-over fashion. Blood sampling will be done at the moment of start of breakfast (0 min) and then 10, 20, 30, 60, 90, 120, 150, 180 min. Plasma glucose levels, total/active GLP-1, GIP, insulin, C-peptide, glucagon will be measured. Incremental area under the curve (iAUC) of glucose level and hormone from 0 min to 180 min will be calculated.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 110-744
        • Seoul National University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • BMI 18.5~35 kg/m2

  • Healthy volunteer:

    • never diagnosed by diabetes and
    • fasting plasma glucose <=100mg/dl and HbA1c <6.0%

  • participants with diabetes

    • diagnosed by diabetes
    • if treated by diet, HbA1c 6.0~9.0%
    • if treated by metformin or SU, HbA1c 6.0~10.0%
    • if treated by DPP4 inhibitor HbA1c 6.0~9.0%

Exclusion Criteria:

  • Those who diagnosed by Type 1 diabetes
  • History of DKA
  • History of insulin therapy
  • Allergy to wheat, flour, nuts, milk
  • Pregnancy/lactation
  • AST or ALT >2.5 times of upper normal reference range
  • eGFR <30 mL/min/1.73m2
  • Hb <10g/dl
  • History of GI surgery (except hemorrhoidectomy, appendectomy)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: premeal protein bar first

intervention: premeal protein-enriched bar intake

  • protein enriched bar(total serving: 30g, 43.28% carbohydrate; 1.29% fat; 40.39% protein; 42.63% fiber) will be given 30 minutes before breakfast
  • protein enriched bar is provided with 150 ml of water
  • amount of protein bar : 30g
  • breakfast : plain bagel, cream cheese, strawberry jam, orange juice 210ml
Kosttilskud: premeal protein-enriched bar intake
Premeal protein bar is provided 30 minutes before breakfast. Participants have to eat protein bar with in 5 minutes with 150ml of water.
Andre navne:
  • premeal protein bar
Andet: breakfast first

intervention: breakfast follows by protein bar

  • protein enriched bar is provided with 150 ml of water shortly after breakfast
  • amount of protein bar : 30g
  • breakfast : plain bagel, cream cheese, strawberry jam, orange juice 210ml
Andet: breakfast follows by protein bar
Participants have to eat provided breakfast within 30 minutes. It is recommended for participants to eat protein bar shortly after finishing breakfast within 5 minutes.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
plasma glucose level after breakfast
Tidsramme: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve (AUC) of plasma glucose level after breakfast
Tidsramme: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

Sekundære resultatmål

Resultatmål
Tidsramme
plasma total/active GLP-1 level after breakfast
Tidsramme: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma total/active GLP-1 level after breakfast
Tidsramme: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma GIP level after breakfast
Tidsramme: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma GIP level after breakfast
Tidsramme: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma insulin level after breakfast
Tidsramme: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma insulin level after breakfast
Tidsramme: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma C-peptide level after breakfast
Tidsramme: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma C-peptide level after breakfast
Tidsramme: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma glucagon level after breakfast
Tidsramme: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma glucagon level after breakfast
Tidsramme: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seoul National University Hospital

Efterforskere

  • Studiestol: Young Min Cho, MD, PHD, Associate Professor Division of Endocrinology and Metabolism Department of Internal Medicine Seoul National University College of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2015

Primær færdiggørelse (Faktiske)

1. juli 2016

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

26. oktober 2015

Først indsendt, der opfyldte QC-kriterier

26. oktober 2015

Først opslået (Skøn)

28. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. november 2017

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H-1504-103-666

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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