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Completed

NCT Number: NCT02533986

Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

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.

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Key information

Conditions

Healthy Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Food for Health Science Centre (Medicon Village) - Lund University

Lund, Skåne County, 221 00, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Berry peel drink

Dietary Supplement

Control drink

Dietary Supplement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

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

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Aug 27, 2015
Registry last updated
Feb 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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