Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects
10 februari 2016 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
23
Fas
- Fas 2
- Fas 1
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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Skåne
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Lund, Skåne, Sverige, 221 00
- Food for Health Science Centre (Medicon Village) - Lund 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 40 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: 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.
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Experimentell: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postprandial blood glucose response after acute intervention
Tidsram: -30, 0, 15, 30, 45, 60, 120, and 180 min after challenge meal.
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The capillary blood will be collected for glucose analysis using a glucometer.
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-30, 0, 15, 30, 45, 60, 120, and 180 min after challenge meal.
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Incremental area under curve (iAUC) blood glucose response after long-term intervention
Tidsram: 4 weeks
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The capillary blood will be collected for glucose analysis using a glucometer.
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4 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postprandial serum insulin response after acute intervention
Tidsram: -30, 0, 15, 30, 45, 60, 120, and 180 min.
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The capillary blood will be collected for insulin analysis using commercial ELISA kits
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-30, 0, 15, 30, 45, 60, 120, and 180 min.
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Incremental area under curve (iAUC) serum insulin response after long-term intervention
Tidsram: 4 weeks
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The capillary blood will be collected for insulin analysis using commercial ELISA kits
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4 weeks
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Postprandial subjective appetite rating after acute intervention
Tidsram: -30, 0, 15, 30, 45, 60, 120, and 180 min.
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Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).
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-30, 0, 15, 30, 45, 60, 120, and 180 min.
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Incremental area under curve (iAUC) subjective appetite rating after long-term intervention
Tidsram: 4 weeks
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Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).
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4 weeks
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Postprandial C-reactive protein (CRP) after acute intervention
Tidsram: -30, 60, 120, and 180 min.
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The venous blood will be collected for CRP analysis using ELISA commercial kits
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-30, 60, 120, and 180 min.
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Incremental area under curve (iAUC) of C-reactive protein (CRP) after long-term intervention
Tidsram: 4 weeks
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The venous blood will be collected for inflammatory analysis using ELISA commercial kits
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4 weeks
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Postprandial adiponectin after acute intervention
Tidsram: -30, 0, 60, 120, and 180 min.
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The venous blood will be collected for adiponectin analysis using ELISA commercial kits
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-30, 0, 60, 120, and 180 min.
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Postprandial adiponectin after long-term intervention with berry peel
Tidsram: 4 weeks
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The venous blood will be collected for adiponectin analysis using ELISA commercial kits
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4 weeks
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Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after acute intervention
Tidsram: 180 min after challenge meal.
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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.
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180 min after challenge meal.
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Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after long-term intervention
Tidsram: -30 min. (Day-28 control); 180 min. (Day-28 control); -30 min. (Day-28 berry); 180 min. (Day-28 berry)
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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.
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-30 min. (Day-28 control); 180 min. (Day-28 control); -30 min. (Day-28 berry); 180 min. (Day-28 berry)
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Postprandial selective attention after long-term intervention
Tidsram: 45, 90, and 180 min after challenge meal.
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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.
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45, 90, and 180 min after challenge meal.
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Postprandial interleukin-6 (IL-6) after acute intervention
Tidsram: -30, 60, 120, and 180 min.
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The venous blood will be collected for IL-6 analysis using ELISA commercial kits
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-30, 60, 120, and 180 min.
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Incremental area under curve (iAUC) of interleukin-6 (IL-6) after long-term intervention
Tidsram: 4 weeks
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The venous blood will be collected for IL-6 analysis using ELISA commercial kits
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4 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Yoghatama Cindya Zanzer, MSc, Lund University
- Studiestol: Angela G Batista, MSc, Lund University; University of Campinas
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 augusti 2015
Primärt slutförande (Faktisk)
1 december 2015
Avslutad studie (Faktisk)
1 januari 2016
Studieregistreringsdatum
Först inskickad
20 augusti 2015
Först inskickad som uppfyllde QC-kriterierna
24 augusti 2015
Första postat (Uppskatta)
27 augusti 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
11 februari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 februari 2016
Senast verifierad
1 februari 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- COGBERRY-BR
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 .