MedPath

Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Dietary Supplement: Control drink
Dietary Supplement: Berry peel drink
Registration Number
NCT02533986
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
23
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Control drinkControl drinkDietary 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.
Berry peel drinkBerry peel drinkDietary 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.
Primary Outcome Measures
NameTimeMethod
Postprandial blood glucose response after acute intervention-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.

Incremental area under curve (iAUC) blood glucose response after long-term intervention4 weeks

The capillary blood will be collected for glucose analysis using a glucometer.

Secondary Outcome Measures
NameTimeMethod
Postprandial subjective appetite rating after acute intervention-30, 0, 15, 30, 45, 60, 120, and 180 min.

Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).

Incremental area under curve (iAUC) of interleukin-6 (IL-6) after long-term intervention4 weeks

The venous blood will be collected for IL-6 analysis using ELISA commercial kits

Incremental area under curve (iAUC) of C-reactive protein (CRP) after long-term intervention4 weeks

The venous blood will be collected for inflammatory analysis using ELISA commercial kits

Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after acute intervention180 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.

Postprandial interleukin-6 (IL-6) after acute intervention-30, 60, 120, and 180 min.

The venous blood will be collected for IL-6 analysis using ELISA commercial kits

Postprandial adiponectin after acute intervention-30, 0, 60, 120, and 180 min.

The venous blood will be collected for adiponectin analysis using ELISA commercial kits

Postprandial selective attention after long-term intervention45, 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.

Postprandial serum insulin response after acute intervention-30, 0, 15, 30, 45, 60, 120, and 180 min.

The capillary blood will be collected for insulin analysis using commercial ELISA kits

Incremental area under curve (iAUC) serum insulin response after long-term intervention4 weeks

The capillary blood will be collected for insulin analysis using commercial ELISA kits

Incremental area under curve (iAUC) subjective appetite rating after long-term intervention4 weeks

Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).

Postprandial C-reactive protein (CRP) after acute intervention-30, 60, 120, and 180 min.

The venous blood will be collected for CRP analysis using ELISA commercial kits

Postprandial adiponectin after long-term intervention with berry peel4 weeks

The venous blood will be collected for adiponectin analysis using ELISA commercial kits

Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after long-term intervention-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.

Trial Locations

Locations (1)

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

🇸🇪

Lund, Skåne, Sweden

© Copyright 2025. All Rights Reserved by MedPath