Effect of Brazilian Fruits Peel on Metabolic Regulation and Appetite in Healthy Subjects (BRASIL-MET)

September 6, 2016 updated by: Elin Östman, Lund University

Investigation on Effect of Brazilian Fruits on Glucose and Insulin Responses, Anti-inflammatory Properties, Antioxidative Capacity and Satiety in Healthy Subjects

The purpose of the study was to investigate how Brazilian fruits peel affect acute/postprandial glucose and insulin responses, inflammatory markers, appetite control peptides, antioxidative capacity, as well as subjective appetite ratings (VAS-visual analogue scales) in healthy volunteers. We hypothesize that certain Brazilian fruits peel added to a standardized meal will improve postprandial glucose tolerance and other metabolic biomarkers in healthy volunteers, compared with a similar meal without the corresponding plant materials.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne
      • Lund, Skåne, Sweden, 221 00
        • Antidiabetic Food Centre (Medicon Village) - Lund University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and females
  • Signed informed consent
  • BMI 20 - 28 kg/m2 with weight change <3 kg latest 2 months
  • Must be able to accept plant-based foods/drinks

Exclusion Criteria:

  • Below 18 years
  • Uncomfortable speaking English and/or difficulties in understanding spoken English
  • Smoking or using snuff
  • Vegetarian or vegan
  • Stressed by venous blood sampling or previous experience of being difficult to cannulate
  • Receiving any drug treatment that may influence the study outcomes
  • Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control drink
300 ml control drink containing equal amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration
Dietary supplement: Control drink
As a control, subjects are asked to consume 300 ml control drinks containing equal amount of total fiber and pectine as Brazilian fruit drink. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
Experimental: Brazilian fruit peel
300 ml test drink containing Brazilian fruit peel flour, acute study / one time administration
Dietary supplement: Brazilian fruit peel flour
In this study, subjects are asked to consume 300 ml beverage drinks contain certain amounts of Brazilian fruit peel flour. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
Placebo Comparator: Negative control drink
300 ml control drink without containing amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration
Dietary supplement: Negative control drink
As a negative control, subjects are asked to consume 300 ml control drinks without containing amount of total fiber and pectine as Brazilian fruit drink. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing on blood glucose concentration after treatment with brazilian fruits peel
Time Frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min
The capillary blood samples will be taken for blood glucose analysis
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing on subjective appetite ratings after treatment with Brazilian fruits peel
Time Frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
Appetite will be assessed using standard subjective 100 mm VAS (visual analogue scale) at time intervals throughout each visit
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
Identify plasma metabolite profile (untargeted approach) after treatment with Brazilian fruits peel
Time Frame: Prior to the initial intervention at 0 min and after intervention at 60, 90, 120, 180 min.
Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods
Prior to the initial intervention at 0 min and after intervention at 60, 90, 120, 180 min.
Changing on insulin after treatment with Brazilian fruits peel
Time Frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
The venous serum blood samples will be taken for insulin analysis
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
Changing on inflammatory markers (i.e. interleukin-6, interleukin-8, tumor necrosis factor-alpha, necrosis factor kappa-beta, adiponectin and C-reactive protein) after treatment with Brazilian fruits peel
Time Frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
The venous serum blood samples will be taken for inflammatory markers analysis
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
Changing on appetite markers (i.e. ghrelin, cholecystokinin, glucagon-like peptide-1, gastric inhibitory polypeptide, peptide YY, amylin, pancreatic polypeptide) after treatment with Brazilian fruits peel
Time Frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
The venous serum blood samples will be taken for appetite markers analysis
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

University of Campinas, Brazil

Investigators

  • Principal Investigator: Elin Östman, PhD, Lund University
  • Study Chair: Glaucia Lima, MSc, Lund University
  • Study Chair: Yoghatama Cindya Zanzer, MSc, Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BRASIL-MET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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