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Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

10. februar 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

23

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 40 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Kosttilskudd: Kontrolldrikk
Eksperimentell: 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.
Kosttilskudd: Berry peel drink

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Lund University

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2015

Primær fullføring (Faktiske)

1. desember 2015

Studiet fullført (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først innsendt

20. august 2015

Først innsendt som oppfylte QC-kriteriene

24. august 2015

Først lagt ut (Anslag)

27. august 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. februar 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. februar 2016

Sist bekreftet

1. februar 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • COGBERRY-BR

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