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Trial record 79 of 3094 for:    Area Under Curve AND Healthy

Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02533986
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : February 11, 2016
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
University of Campinas, Brazil
Information provided by (Responsible Party):
Elin Östman, Lund University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Berry peel drink Dietary Supplement: Control drink Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects
Study Start Date : August 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Placebo Comparator: 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.
Dietary Supplement: Control drink
Experimental: 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.
Dietary Supplement: Berry peel drink



Primary Outcome Measures :
  1. Postprandial blood glucose response after acute intervention [ Time Frame: -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.

  2. Incremental area under curve (iAUC) blood glucose response after long-term intervention [ Time Frame: 4 weeks ]
    The capillary blood will be collected for glucose analysis using a glucometer.


Secondary Outcome Measures :
  1. Postprandial serum insulin response after acute intervention [ Time Frame: -30, 0, 15, 30, 45, 60, 120, and 180 min. ]
    The capillary blood will be collected for insulin analysis using commercial ELISA kits

  2. Incremental area under curve (iAUC) serum insulin response after long-term intervention [ Time Frame: 4 weeks ]
    The capillary blood will be collected for insulin analysis using commercial ELISA kits

  3. Postprandial subjective appetite rating after acute intervention [ Time Frame: -30, 0, 15, 30, 45, 60, 120, and 180 min. ]
    Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).

  4. Incremental area under curve (iAUC) subjective appetite rating after long-term intervention [ Time Frame: 4 weeks ]
    Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).

  5. Postprandial C-reactive protein (CRP) after acute intervention [ Time Frame: -30, 60, 120, and 180 min. ]
    The venous blood will be collected for CRP analysis using ELISA commercial kits

  6. Incremental area under curve (iAUC) of C-reactive protein (CRP) after long-term intervention [ Time Frame: 4 weeks ]
    The venous blood will be collected for inflammatory analysis using ELISA commercial kits

  7. Postprandial adiponectin after acute intervention [ Time Frame: -30, 0, 60, 120, and 180 min. ]
    The venous blood will be collected for adiponectin analysis using ELISA commercial kits

  8. Postprandial adiponectin after long-term intervention with berry peel [ Time Frame: 4 weeks ]
    The venous blood will be collected for adiponectin analysis using ELISA commercial kits

  9. Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after acute intervention [ Time Frame: 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.

  10. Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after long-term intervention [ Time Frame: -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.

  11. Postprandial selective attention after long-term intervention [ Time Frame: 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.

  12. Postprandial interleukin-6 (IL-6) after acute intervention [ Time Frame: -30, 60, 120, and 180 min. ]
    The venous blood will be collected for IL-6 analysis using ELISA commercial kits

  13. Incremental area under curve (iAUC) of interleukin-6 (IL-6) after long-term intervention [ Time Frame: 4 weeks ]
    The venous blood will be collected for IL-6 analysis using ELISA commercial kits



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533986


Locations
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Sweden
Food for Health Science Centre (Medicon Village) - Lund University
Lund, Skåne, Sweden, 221 00
Sponsors and Collaborators
Lund University
Conselho Nacional de Desenvolvimento Científico e Tecnológico
University of Campinas, Brazil
Investigators
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Study Chair: Angela G Batista, MSc Lund University; University of Campinas
Study Chair: Yoghatama Cindya Zanzer, MSc Lund University

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Responsible Party: Elin Östman, Assoc. Prof., PhD, Lund University
ClinicalTrials.gov Identifier: NCT02533986     History of Changes
Other Study ID Numbers: COGBERRY-BR
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016

Keywords provided by Elin Östman, Lund University:
Berry
Inflammation
Cognition
Polyphenols
Appetite
Glucose metabolism