Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

NCT ID: NCT02533986

Last Updated: 2016-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Control drink

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type EXPERIMENTAL

Berry peel drink

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Berry peel drink

Intervention Type DIETARY_SUPPLEMENT

Control drink

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lund University

OTHER

Sponsor Role lead

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Campinas, Brazil

OTHER

Sponsor Role collaborator

Responsible Party

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Elin Östman

Assoc. Prof., PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angela G Batista, MSc

Role: STUDY_CHAIR

Lund University; University of Campinas

Yoghatama Cindya Zanzer, MSc

Role: STUDY_CHAIR

Lund University

Locations

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

Lund, Skåne County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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COGBERRY-BR

Identifier Type: -

Identifier Source: org_study_id

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