Overweight and ObesityPhase 1NCT02613715
Bioavailability of Blackberry Juice Anthocyanins
A Phase 1 study testing Blackberry juice with 12% ethanol and Blackberry juice in people with Overweight and Obesity and Healthy, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The main aim of this study is to evaluate the bioavailability of blackberry juice anthocyanins, with or without ethanol, in normal weight and overweight/obese adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Healthy
- What is being tested?
- Blackberry juice with 12% ethanol and Blackberry juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePortugal
- Study dates
- Mar 2015to Jun 2015
- Phase
- Phase 1
- 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
- Men and women
- Age 18-40 years
- BMI>18 kg/m2
- Willing and able to provide written consent
Who cannot join
- Subjects with current or previous CVD, diabetes or other severe chronic disease
- Subjects under prescription of any chronic medication
- Pregnant or breast-feeding subjects
- Intake of antibiotics in the last 3 months prior to the beginning of the intervention
- Intake of red fruits or red wine in the last 24 h prior to the beginning of the intervention
- Subjects involved in any clinical or food study within the preceding month
- Subjects with a diagnosis of any digestive disease including functional bowel disorder such as IBS
Trial locations and contacts
1 site in 1 country.
Portugal1 site
CINTESIS - Faculty of Medicine of the University of Porto
Porto, 4200-450
About this study
Official title: Influence of Ethanol in the Bioavailability of Blackberry Juice Anthocyanins in Normal Weight and Overweight/Obese Adults
The main aim of this study is to evaluate the bioavailability of blackberry juice anthocyanins, with or without ethanol, in normal weight and overweight/obese adults.
Read the detailed description
Anthocyanins (ANT), a particular class of flavonoids that can be found in red wine and red fruits, have been associated with relevant health benefits. It has become clear that the flavonoid bioactive forms in vivo are not necessarily those which occur in nature, but metabolites arising from them after absorption. Therefore, it is important to identify which ANT metabolites are responsible for their health benefits. Since ANT can prevent/treat some of the metabolic features of obesity it is also crucial to study whether ANT bioavailability is not compromised in obesity.
An anthropometric evaluation will allow the classification of subjects according to their body mass index (BMI). A complete medical examination including the assessment of clinical laboratory parameters will also be performed to characterize the health status of recruited subjects.
Before the beginning of the study, the last fecal sample obtained will be collected. Urine samples and peripheral venous blood (10 ml) will be collected from 10 h-fasting subjects. Afterwards, each volunteer will consume 250 ml of blackberry juice with or without ethanol (visit 1 and 2) and blood samples will be collected 15, 30, 60 and 120 min after juice ingestion. Another urine sample will be collected at 120 min. The first fecal sample obtained at least 6 h after juice ingestion will be collected. Blood pressure (0 and 120 min) and glycaemic response (0, 15, 30, 60 and 120 min) will be measured in each visit.
Ethanol was added to the blackberry juice to mimic the concentration presented in red wine (12%).
A thorough screening analysis for ANT will be performed in plasma and urine samples collected from the volunteers at different time points. Fecal samples will also be collected to evaluate the relationship between the presence of ANT metabolites and the gut microbiota composition.
- Conditions
- Overweight and Obesity, Healthy
- Being tested
- Blackberry juice with 12% ethanol, Blackberry juice
- Keywords
- Flavonoids, Anthocyanins, Blackberry Juice, Bioavailability, Obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blackberry juice with 12% ethanolDietary supplement
Blackberry juiceDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Blackberry juice with 12% ethanol | Experimental | 250 ml of blackberry juice freshly prepared with 250 g fresh blackberries, 80 ml alcohol beverage (38%) and 17 g sugar. Receives: Dietary Supplement: Blackberry juice with 12% ethanol |
| Blackberry juice | Experimental | 250 ml of blackberry juice freshly prepared with 250 g fresh blackberries, 80 ml water and 17 g sugar. Receives: Dietary Supplement: Blackberry juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of anthocyanins and anthocyanins metabolites
Measured: At baseline and 15, 30, 60 and 120 minutes after juices consumption
Secondary outcomes (5)
Urinary concentrations of anthocyanins and anthocyanins metabolites
Measured: At baseline and 120 minutes after juices consumption
Fecal concentrations of anthocyanins and anthocyanins metabolites
Measured: At baseline and at least 6 h after juices consumption
Number of copies of bacterias presented in fecal samples
Measured: At baseline and at least 6 h after juices consumption
Blood pressure measured in the left upper arm using an automatic blood pressure monitor
Measured: At baseline and 120 minutes after juices consumption
Capillary blood glucose concentration
Measured: At baseline and 15, 30, 60 and 120 minutes after juices consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Health Technology and Services Research, Vinoflavo
- Responsible party
- Sponsor
- Investigators
- Conceição Calhau, PhD, Principal investigator, CINTESIS - Faculty of Medicine of University of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613715
- Sponsor's protocol ID
- VINOFLAVO_01
- Status last verified
- Oct 2015
- First submitted
- 16 Nov 2015
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Ethanol in the Bioavailability of Blackberry Juice Anthocyanins in Normal Weight and Overweight/Obese Adults
- ClinicalTrials.gov ID
- NCT02613715
- Acronym / sponsor ID
- VINOFLAVO_01
- Conditions
- Overweight and Obesity, Healthy
- Keywords
- Flavonoids, Anthocyanins, Blackberry Juice, Bioavailability, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Center for Health Technology and Services Research, Vinoflavo
- Study start
- Mar 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Nov 2015 (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 main aim of this study is to evaluate the bioavailability of blackberry juice anthocyanins, with or without ethanol, in normal weight and overweight/obese adults.
Detailed description
Anthocyanins (ANT), a particular class of flavonoids that can be found in red wine and red fruits, have been associated with relevant health benefits. It has become clear that the flavonoid bioactive forms in vivo are not necessarily those which occur in nature, but metabolites arising from them after absorption. Therefore, it is important to identify which ANT metabolites are responsible for their health benefits. Since ANT can prevent/treat some of the metabolic features of obesity it is also crucial to study whether ANT bioavailability is not compromised in obesity.
An anthropometric evaluation will allow the classification of subjects according to their body mass index (BMI). A complete medical examination including the assessment of clinical laboratory parameters will also be performed to characterize the health status of recruited subjects.
Before the beginning of the study, the last fecal sample obtained will be collected. Urine samples and peripheral venous blood (10 ml) will be collected from 10 h-fasting subjects. Afterwards, each volunteer will consume 250 ml of blackberry juice with or without ethanol (visit 1 and 2) and blood samples will be collected 15, 30, 60 and 120 min after juice ingestion. Another urine sample will be collected at 120 min. The first fecal sample obtained at least 6 h after juice ingestion will be collected. Blood pressure (0 and 120 min) and glycaemic response (0, 15, 30, 60 and 120 min) will be measured in each visit.
Ethanol was added to the blackberry juice to mimic the concentration presented in red wine (12%).
A thorough screening analysis for ANT will be performed in plasma and urine samples collected from the volunteers at different time points. Fecal samples will also be collected to evaluate the relationship between the presence of ANT metabolites and the gut microbiota composition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blackberry juice with 12% ethanol | Experimental | Dietary Supplement: Blackberry juice with 12% ethanol250 ml of blackberry juice freshly prepared with 250 g fresh blackberries, 80 ml alcohol beverage (38%) and 17 g sugar. |
| Blackberry juice | Experimental | Dietary Supplement: Blackberry juice250 ml of blackberry juice freshly prepared with 250 g fresh blackberries, 80 ml water and 17 g sugar. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women
- Age 18-40 years
- BMI>18 kg/m2
- Willing and able to provide written consent
Key exclusion criteria (7 listed)
- Subjects with current or previous CVD, diabetes or other severe chronic disease
- Subjects under prescription of any chronic medication
- Pregnant or breast-feeding subjects
- Intake of antibiotics in the last 3 months prior to the beginning of the intervention
- Intake of red fruits or red wine in the last 24 h prior to the beginning of the intervention
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 |
|---|---|---|
| Blackberry juice with 12% ethanol | Dietary supplement | Blackberry juice with 12% ethanol |
| Blackberry juice | Dietary supplement | Blackberry juice |
Primary outcome
Plasma concentrations of anthocyanins and anthocyanins metabolites
Time frame: At baseline and 15, 30, 60 and 120 minutes after juices consumption
5 secondary outcomes
Urinary concentrations of anthocyanins and anthocyanins metabolites
Time frame: At baseline and 120 minutes after juices consumption
Fecal concentrations of anthocyanins and anthocyanins metabolites
Time frame: At baseline and at least 6 h after juices consumption
Number of copies of bacterias presented in fecal samples
Time frame: At baseline and at least 6 h after juices consumption
Blood pressure measured in the left upper arm using an automatic blood pressure monitor
Time frame: At baseline and 120 minutes after juices consumption
Capillary blood glucose concentration
Time frame: At baseline and 15, 30, 60 and 120 minutes after juices consumption
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 24 Nov 2015.
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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.
Conceição Calhau, PhD principal investigator
CINTESIS - Faculty of Medicine of University of Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Blackberry juice with 12% ethanol and Blackberry juice in people with Overweight and Obesity and Healthy, run by Universidade do Porto at 1 site in Portugal.
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 24 Nov 2015. 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 Portugal. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Plasma concentrations of anthocyanins and anthocyanins metabolites (time frame: At baseline and 15, 30, 60 and 120 minutes after juices consumption). 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 24 Nov 2015.