Effect of Brazilian Fruits Peel on Metabolic Regulation and Appetite in Healthy Subjects

NCT ID: NCT02245906

Last Updated: 2016-09-07

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control drink

300 ml control drink containing equal amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration

Group Type PLACEBO_COMPARATOR

Control drink

Intervention Type DIETARY_SUPPLEMENT

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.

Brazilian fruit peel

300 ml test drink containing Brazilian fruit peel flour, acute study / one time administration

Group Type EXPERIMENTAL

Brazilian fruit peel flour

Intervention Type DIETARY_SUPPLEMENT

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.

Negative control drink

300 ml control drink without containing amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration

Group Type PLACEBO_COMPARATOR

Negative control drink

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Campinas, Brazil

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elin Östman

Assoc. Prof, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elin Östman, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Glaucia Lima, MSc

Role: STUDY_CHAIR

Lund University

Yoghatama Cindya Zanzer, MSc

Role: STUDY_CHAIR

Lund University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Antidiabetic Food Centre (Medicon Village) - Lund University

Lund, Skåne County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BRASIL-MET

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.