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Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

10. februar 2016 opdateret af: Elin Östman, Lund University
The main objective of this study is to investigate the effect of a 4-weeks intake of berry peel powder on fasting and postprandial glucose metabolism and inflammatory markers. The berry peel product will be compared with a placebo in a single-blind, cross-over design. Furthermore, inflammation-related peripheral blood mononuclear cells (PBMCs) genes expression, appetite and cognitive performance will be included as a pilot study. Investigators hypothesize that long-term consumption of polyphenols and fibres of berry peel will exhibit both direct and indirect actions in healthy overweight subjects by improvement of glucose-associated markers as well as ameliorating inflammation. Moreover, above metabolic markers will correlated with improvements in inflammation-related PBMCs genes expression, subjective appetite and cognitive performance after long-term consumption of berry peel as a source of polyphenols.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

23

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Sverige
    • Skåne
      • Lund, Skåne, Sverige, 221 00
        • Food for Health Science Centre (Medicon Village) - Lund University

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

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy males and females
  • Signed informed consent
  • BMI 25-30 kg/m2
  • Must be able to accept plant-based foods/drinks

Exclusion Criteria:

  • Below 18 years or above 40 years
  • Smoking or using snuff
  • vegetarian or vegan
  • Stressed by venous blood sampling or previous experience of being difficult canulation

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Control drink
Dietary supplement: Control drink As control, subjects are asked to consume 150 ml control drink containing equal amount of insoluble fiber (cellulose) and sugar for 28 days. In addition, on days-1 and 28, subjects will receive an acute challenge of placebo drink at our clinical facility. After 30 min. control drink intake, subjects will be given standardized breakfast corresponding to 50 g available carbohydrates.
Kosttilskud: Kontrol drik
Eksperimentel: Berry peel drink
Dietary supplement: Berry peel drink Subjects are asked to consume 150 ml experimental drink containing a berry peel fruit powder. In addition, on days-1 and 28, subjects will receive an acute challenge of test drink at our clinical facility. After 30 min. berry drink intake, subjects will be given standardized breakfast corresponding to 50 g available carbohydrates.
Kosttilskud: Berry peel drink

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postprandial blood glucose response after acute intervention
Tidsramme: -30, 0, 15, 30, 45, 60, 120, and 180 min after challenge meal.
The capillary blood will be collected for glucose analysis using a glucometer.
-30, 0, 15, 30, 45, 60, 120, and 180 min after challenge meal.
Incremental area under curve (iAUC) blood glucose response after long-term intervention
Tidsramme: 4 weeks
The capillary blood will be collected for glucose analysis using a glucometer.
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postprandial serum insulin response after acute intervention
Tidsramme: -30, 0, 15, 30, 45, 60, 120, and 180 min.
The capillary blood will be collected for insulin analysis using commercial ELISA kits
-30, 0, 15, 30, 45, 60, 120, and 180 min.
Incremental area under curve (iAUC) serum insulin response after long-term intervention
Tidsramme: 4 weeks
The capillary blood will be collected for insulin analysis using commercial ELISA kits
4 weeks
Postprandial subjective appetite rating after acute intervention
Tidsramme: -30, 0, 15, 30, 45, 60, 120, and 180 min.
Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).
-30, 0, 15, 30, 45, 60, 120, and 180 min.
Incremental area under curve (iAUC) subjective appetite rating after long-term intervention
Tidsramme: 4 weeks
Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).
4 weeks
Postprandial C-reactive protein (CRP) after acute intervention
Tidsramme: -30, 60, 120, and 180 min.
The venous blood will be collected for CRP analysis using ELISA commercial kits
-30, 60, 120, and 180 min.
Incremental area under curve (iAUC) of C-reactive protein (CRP) after long-term intervention
Tidsramme: 4 weeks
The venous blood will be collected for inflammatory analysis using ELISA commercial kits
4 weeks
Postprandial adiponectin after acute intervention
Tidsramme: -30, 0, 60, 120, and 180 min.
The venous blood will be collected for adiponectin analysis using ELISA commercial kits
-30, 0, 60, 120, and 180 min.
Postprandial adiponectin after long-term intervention with berry peel
Tidsramme: 4 weeks
The venous blood will be collected for adiponectin analysis using ELISA commercial kits
4 weeks
Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after acute intervention
Tidsramme: 180 min after challenge meal.
The venous blood samples will be taken for isolation of peripheral blood mononuclear cells (PBMCs). Extracted total RNA will then be used for running quantitative-PCR.
180 min after challenge meal.
Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after long-term intervention
Tidsramme: -30 min. (Day-28 control); 180 min. (Day-28 control); -30 min. (Day-28 berry); 180 min. (Day-28 berry)
The venous blood samples will be taken for isolation of peripheral blood mononuclear cells (PBMCs). Extracted total RNA will then be used for running quantitative-PCR.
-30 min. (Day-28 control); 180 min. (Day-28 control); -30 min. (Day-28 berry); 180 min. (Day-28 berry)
Postprandial selective attention after long-term intervention
Tidsramme: 45, 90, and 180 min after challenge meal.
The selective attention will be assessed using a standardized software (Röd and Grön software) that measures wrong/right decisions and time of reaction when the subjects is faced with a challenging stimulus.
45, 90, and 180 min after challenge meal.
Postprandial interleukin-6 (IL-6) after acute intervention
Tidsramme: -30, 60, 120, and 180 min.
The venous blood will be collected for IL-6 analysis using ELISA commercial kits
-30, 60, 120, and 180 min.
Incremental area under curve (iAUC) of interleukin-6 (IL-6) after long-term intervention
Tidsramme: 4 weeks
The venous blood will be collected for IL-6 analysis using ELISA commercial kits
4 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Lund University

Samarbejdspartnere

University of Campinas, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Efterforskere

  • Studiestol: Yoghatama Cindya Zanzer, MSc, Lund University
  • Studiestol: Angela G Batista, MSc, Lund University; University of Campinas

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. august 2015

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først indsendt

20. august 2015

Først indsendt, der opfyldte QC-kriterier

24. august 2015

Først opslået (Skøn)

27. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • COGBERRY-BR

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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