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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Control drink
* Dietary Supplement: Brazilian fruit peel flour
* Dietary Supplement: Negative control drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control drink<br>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<br>* 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.<br>|
| Experimental: Brazilian fruit peel<br>300 ml test drink containing Brazilian fruit peel flour, acute study / one time administration | Dietary Supplement: Brazilian fruit peel flour<br>* 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.<br>|
| Placebo Comparator: Negative control drink<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brazilian fruit peel, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Appetite, Gut hormone