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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Control drink; Dietary supplement: Berry peel drink

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Lund, Skåne, Sweden, 221 00
      • Food for Health Science Centre (Medicon Village) - Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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.
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
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.
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
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.
Postprandial adiponectin after long-term intervention with berry peel	The venous blood will be collected for adiponectin analysis using ELISA commercial kits	4 weeks
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.
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)
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.
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.
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

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: University of Campinas, Brazil; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Study Chair: Yoghatama Cindya Zanzer, MSc, Lund University; Study Chair: Angela G Batista, MSc, Lund University; University of Campinas

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: August 20, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Estimate): February 11, 2016
• Last Update Submitted That Met QC Criteria: February 10, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Inflammation; Cognition; Polyphenols; Appetite; Glucose metabolism; Berry
• Other Study ID Numbers: COGBERRY-BR