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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Control drink; Dietary Supplement: Brazilian fruit peel flour; Dietary Supplement: Negative control drink

• Registration Number: NCT02245906
• Lead Sponsor: Lund University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-22
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control drink	Control drink	300 ml control drink containing equal amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration
Brazilian fruit peel	Brazilian fruit peel flour	300 ml test drink containing Brazilian fruit peel flour, acute study / one time administration
Negative control drink	Negative control drink	300 ml control drink without containing amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration

Primary Outcome Measures

Name	Time	Method
Changing on blood glucose concentration 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	The capillary blood samples will be taken for blood glucose analysis

Secondary Outcome Measures

Name	Time	Method
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.	Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods
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.	The venous serum blood samples will be taken for appetite markers analysis
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.	Appetite will be assessed using standard subjective 100 mm VAS (visual analogue scale) at time intervals throughout each visit
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.	The venous serum blood samples will be taken for insulin analysis
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.	The venous serum blood samples will be taken for inflammatory markers analysis

Trial Locations

Locations (1)

Antidiabetic Food Centre (Medicon Village) - Lund University; 🇸🇪 Lund, Skåne, Sweden