Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

Healthy Clinical Trial

Official title:

Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533986
• Other study ID #: COGBERRY-BR
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 20, 2015
• Last updated: February 10, 2016
• Start date: August 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Berry peel drink

• Control drink

Locations

Country	Name	City	State
Sweden	Food for Health Science Centre (Medicon Village) - Lund University	Lund	Skåne

Sponsors (3)

Lead Sponsor	Collaborator
Lund University	Conselho Nacional de Desenvolvimento Científico e Tecnológico, University of Campinas, Brazil

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial blood glucose response after acute intervention	The capillary blood will be collected for glucose analysis using a glucometer.	-30, 0, 15, 30, 45, 60, 120, and 180 min after challenge meal.	No
Primary	Incremental area under curve (iAUC) blood glucose response after long-term intervention	The capillary blood will be collected for glucose analysis using a glucometer.	4 weeks	No
Secondary	Postprandial serum insulin response after acute intervention	The capillary blood will be collected for insulin analysis using commercial ELISA kits	-30, 0, 15, 30, 45, 60, 120, and 180 min.	No
Secondary	Incremental area under curve (iAUC) serum insulin response after long-term intervention	The capillary blood will be collected for insulin analysis using commercial ELISA kits	4 weeks	No
Secondary	Postprandial subjective appetite rating after acute intervention	Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).	-30, 0, 15, 30, 45, 60, 120, and 180 min.	No
Secondary	Incremental area under curve (iAUC) subjective appetite rating after long-term intervention	Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).	4 weeks	No
Secondary	Postprandial C-reactive protein (CRP) after acute intervention	The venous blood will be collected for CRP analysis using ELISA commercial kits	-30, 60, 120, and 180 min.	No
Secondary	Incremental area under curve (iAUC) of C-reactive protein (CRP) after long-term intervention	The venous blood will be collected for inflammatory analysis using ELISA commercial kits	4 weeks	No
Secondary	Postprandial adiponectin after acute intervention	The venous blood will be collected for adiponectin analysis using ELISA commercial kits	-30, 0, 60, 120, and 180 min.	No
Secondary	Postprandial adiponectin after long-term intervention with berry peel	The venous blood will be collected for adiponectin analysis using ELISA commercial kits	4 weeks	No
Secondary	Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after acute intervention	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.	180 min after challenge meal.	No
Secondary	Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after long-term intervention	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.	-30 min. (Day-28 control); 180 min. (Day-28 control); -30 min. (Day-28 berry); 180 min. (Day-28 berry)	No
Secondary	Postprandial selective attention after long-term intervention	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.	45, 90, and 180 min after challenge meal.	No
Secondary	Postprandial interleukin-6 (IL-6) after acute intervention	The venous blood will be collected for IL-6 analysis using ELISA commercial kits	-30, 60, 120, and 180 min.	No
Secondary	Incremental area under curve (iAUC) of interleukin-6 (IL-6) after long-term intervention	The venous blood will be collected for IL-6 analysis using ELISA commercial kits	4 weeks	No

External Links

•   Food for Health Science Centre, Lund University, SWEDEN