Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

Sponsor

Lund University (Other)

Overall Status

Completed

CT.gov ID

NCT02533986

Collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other), University of Campinas, Brazil (Other)

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Berry peel drink Dietary Supplement: Control drink	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
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) 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
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
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 adiponectin after long-term intervention with berry peel [4 weeks]
The venous blood will be collected for adiponectin 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.
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 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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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