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

Healthy Clinical Trial

— BRASIL-MET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245906
• Other study ID #: BRASIL-MET
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 16, 2014
• Last updated: September 6, 2016
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Antidiabetic Food Centre (Medicon Village) - Lund University	Lund	Skåne

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	University of Campinas, Brazil

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changing on subjective appetite ratings after treatment with Brazilian fruits peel	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.	No
Secondary	Identify plasma metabolite profile (untargeted approach) after treatment with Brazilian fruits peel	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.	No
Secondary	Changing on insulin after treatment with Brazilian fruits peel	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.	No
Secondary	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	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.	No
Secondary	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	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.	No