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

NCT02245906 | Completed Phase 1

• 1 other identifier: BRASIL-MET
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Brazilian fruit peel; Functional food; Cardiometabolic risk; Metabolic syndrome; Inflammation; Appetite; Gut hormone

Outcome Measures

Primary Outcomes (1)

• Changing on blood glucose concentration after treatment with brazilian fruits peel

  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 Outcomes (5)

• Changing on subjective appetite ratings after treatment with Brazilian fruits peel

  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

  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

  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

  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

  Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.

Study Arms (3)

Control drink

PLACEBO COMPARATOR

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

Brazilian fruit peel

EXPERIMENTAL

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

Dietary Supplement: Brazilian fruit peel flour

Negative control drink

PLACEBO COMPARATOR

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

Interventions

Control drink 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.

Control drink

Brazilian fruit peel flour 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.

Brazilian fruit peel

Negative control drink 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.

Negative control drink

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead
• University of Campinas, Brazil: collaborator

Study Sites (1)

Antidiabetic Food Centre (Medicon Village) - Lund University

Lund, Skåne County, 221 00, Sweden

Location

MeSH Terms

Conditions

Metabolic Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elin Östman, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

• Glaucia Lima, MSc

  Lund University

  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: September 16, 2014
• First Posted: September 22, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)