HealthyPhase 1/2BRASIL-METNCT02245906
Effect of Brazilian Fruits Peel on Metabolic Regulation and Appetite in Healthy Subjects
A Phase 1/2 study testing Brazilian fruit peel flour in people with Healthy, run by Lund University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Brazilian fruit peel flour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to Sep 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Antidiabetic Food Centre (Medicon Village) - Lund University
Lund, Skåne County, 221 00
About this study
Official title: Investigation on Effect of Brazilian Fruits on Glucose and Insulin Responses, Anti-inflammatory Properties, Antioxidative Capacity and Satiety 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.
- Conditions
- Healthy
- Being tested
- Control drink, Brazilian fruit peel flour, Negative control drink
- Keywords
- Brazilian fruit peel, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Appetite, Gut hormone
- Medical subject headings
- Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control drinkDietary 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 flourDietary 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 drinkDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Control drink | Placebo comparator | 300 ml control drink containing equal amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration Receives: Dietary Supplement: Control drink |
| Brazilian fruit peel | Experimental | 300 ml test drink containing Brazilian fruit peel flour, acute study / one time administration Receives: Dietary Supplement: Brazilian fruit peel flour |
| Negative control drink | Placebo comparator | 300 ml control drink without containing amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration Receives: Dietary Supplement: Negative control drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing on blood glucose concentration after treatment with brazilian fruits peel
The capillary blood samples will be taken for blood glucose analysis
Measured: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil
- Responsible party
- Principal investigator, Elin Östman, Lund University
- Investigators
- Elin Östman, PhD, Principal investigator, Lund UniversityGlaucia Lima, MSc, Study chair, Lund UniversityYoghatama Cindya Zanzer, MSc, Study chair, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245906
- Sponsor's protocol ID
- BRASIL-MET
- Acronym
- BRASIL-MET
- Status last verified
- Sep 2016
- First submitted
- 16 Sep 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Effect of Brazilian Fruits on Glucose and Insulin Responses, Anti-inflammatory Properties, Antioxidative Capacity and Satiety in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02245906
- Acronym / sponsor ID
- BRASIL-MET / BRASIL-MET
- Conditions
- Healthy
- Keywords
- Brazilian fruit peel, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Appetite, Gut hormone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control drink | Placebo comparator | Dietary Supplement: Control drink300 ml control drink containing equal amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration |
| Brazilian fruit peel | Experimental | Dietary Supplement: Brazilian fruit peel flour300 ml test drink containing Brazilian fruit peel flour, acute study / one time administration |
| Negative control drink | Placebo comparator | Dietary Supplement: Negative control drink300 ml control drink without containing amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control drinkAs 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. | Dietary supplement | Control drink |
| Brazilian fruit peel flourIn 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. | Dietary supplement | Brazilian fruit peel |
| Negative control drinkAs 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. | Dietary supplement | Negative control drink |
Primary outcome
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
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elin Östman, PhD principal investigator
Lund University
Glaucia Lima, MSc study chair
Lund University
Yoghatama Cindya Zanzer, MSc study chair
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Brazilian fruit peel flour in people with Healthy, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.