Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy

• 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

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-27
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11

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

Primary Outcome Measures

Name	Time	Method
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 intervention	4 weeks	The capillary blood will be collected for glucose analysis using a glucometer.

Secondary Outcome Measures

Name	Time	Method
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 intervention	4 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 intervention	4 weeks	The venous blood will be collected for inflammatory analysis using ELISA commercial kits
Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after acute intervention	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.
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 intervention	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.
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 intervention	4 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 intervention	4 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
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.
Postprandial adiponectin after long-term intervention with berry peel	4 weeks	The venous blood will be collected for adiponectin analysis using ELISA commercial kits

Trial Locations

Locations (1)

Food for Health Science Centre (Medicon Village) - Lund University; 🇸🇪 Lund, Skåne, Sweden