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Completed

NCT Number: NCT02245906

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

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Antidiabetic Food Centre (Medicon Village) - Lund University

Lund, Skåne County, 221 00, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Changing on blood glucose concentration after treatment with brazilian fruits peel

    Time frame: 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 outcomes

  1. Changing on subjective appetite ratings after treatment with Brazilian fruits peel

    Time frame: 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

  2. Identify plasma metabolite profile (untargeted approach) after treatment with Brazilian fruits peel

    Time frame: 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

  3. Changing on insulin after treatment with Brazilian fruits peel

    Time frame: 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

  4. 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

    Time frame: 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

  5. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • University of Campinas, Brazil

Registry information

Official study title

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

Acronym: BRASIL-MET

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 22, 2014
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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