Clinical trial NCT02245906: Effect of Brazilian Fruits Peel on Metabolic Regulation and Appetite in Healthy Subjects
Official title: Investigation on Effect of Brazilian Fruits on Glucose and Insulin Responses, Anti-inflammatory Properties, Antioxidative Capacity and Satiety in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Brazilian fruit peel
Functional food
Cardiometabolic risk
Metabolic syndrome
Inflammation
Appetite
Gut hormone
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: University of Campinas, Brazil
First posted: 2014-09-22
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changing on blood glucose concentration after treatment with brazilian fruits peel
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min
Secondary outcomes:
measure: Changing on subjective appetite ratings after treatment with Brazilian fruits peel
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
measure: Identify plasma metabolite profile (untargeted approach) after treatment with Brazilian fruits peel
timeFrame: Prior to the initial intervention at 0 min and after intervention at 60, 90, 120, 180 min.
measure: Changing on insulin after treatment with Brazilian fruits peel
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
measure: 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
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
measure: 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
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Antidiabetic Food Centre (Medicon Village) - Lund University
state: Skåne
Study officials:
affiliation: Lund University
name: Elin Östman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Glaucia Lima, MSc
role: STUDY_CHAIR
affiliation: Lund University
name: Yoghatama Cindya Zanzer, MSc
role: STUDY_CHAIR
References: