NCT02533986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2015

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

August 20, 2015

Last Update Submit

February 10, 2016

Conditions

Healthy

Keywords

BerryInflammationCognitionPolyphenolsAppetiteGlucose metabolism

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (13)

  • Postprandial serum insulin response after acute intervention

    -30, 0, 15, 30, 45, 60, 120, and 180 min.

  • Incremental area under curve (iAUC) serum insulin response after long-term intervention

    4 weeks

  • Postprandial subjective appetite rating after acute intervention

    -30, 0, 15, 30, 45, 60, 120, and 180 min.

  • Incremental area under curve (iAUC) subjective appetite rating after long-term intervention

    4 weeks

  • Postprandial C-reactive protein (CRP) after acute intervention

    -30, 60, 120, and 180 min.

  • +8 more secondary outcomes

Study Arms (2)

Control drink

PLACEBO COMPARATOR

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

Berry peel drink

EXPERIMENTAL

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

Interventions

Berry peel drinkDIETARY_SUPPLEMENT
Berry peel drink
Control drinkDIETARY_SUPPLEMENT
Control drink

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and females
  • Signed informed consent
  • BMI 25-30 kg/m2
  • Must be able to accept plant-based foods/drinks

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lund, Skåne County, 221 00, Sweden

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Angela G Batista, MSc

    Lund University; University of Campinas

    STUDY CHAIR

  • Yoghatama Cindya Zanzer, MSc

    Lund University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof., PhD

Study Record Dates

First Submitted

August 20, 2015

First Posted

August 27, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

February 11, 2016

Record last verified: 2016-02

Locations

SE(1)