Bioavailability of Blackberry Juice Anthocyanins
Primary Purpose
Overweight and Obesity, Healthy
Status
Completed
Phase
Phase 1
Locations
Portugal
Study Type
Interventional
Intervention
Blackberry juice with 12% ethanol
Blackberry juice
Sponsored by
About this trial
This is an interventional basic science trial for Overweight and Obesity focused on measuring Flavonoids, Anthocyanins, Blackberry Juice, Bioavailability, Obesity
Eligibility Criteria
Inclusion Criteria:
- Men and women
- Age 18-40 years
- BMI>18 kg/m2
- Willing and able to provide written consent
Exclusion Criteria:
- 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
Sites / Locations
- CINTESIS - Faculty of Medicine of the University of Porto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Blackberry juice with 12% ethanol
Blackberry juice
Arm Description
250 ml of blackberry juice freshly prepared with 250 g fresh blackberries, 80 ml alcohol beverage (38%) and 17 g sugar.
250 ml of blackberry juice freshly prepared with 250 g fresh blackberries, 80 ml water and 17 g sugar.
Outcomes
Primary Outcome Measures
Plasma concentrations of anthocyanins and anthocyanins metabolites
Secondary Outcome Measures
Urinary concentrations of anthocyanins and anthocyanins metabolites
Fecal concentrations of anthocyanins and anthocyanins metabolites
Number of copies of bacterias presented in fecal samples
Blood pressure measured in the left upper arm using an automatic blood pressure monitor
Capillary blood glucose concentration
Full Information
NCT ID
NCT02613715
First Posted
November 16, 2015
Last Updated
November 20, 2015
Sponsor
Universidade do Porto
Collaborators
Center for Health Technology and Services Research, Vinoflavo
1. Study Identification
Unique Protocol Identification Number
NCT02613715
Brief Title
Bioavailability of Blackberry Juice Anthocyanins
Official Title
Influence of Ethanol in the Bioavailability of Blackberry Juice Anthocyanins in Normal Weight and Overweight/Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Porto
Collaborators
Center for Health Technology and Services Research, Vinoflavo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Healthy
Keywords
Flavonoids, Anthocyanins, Blackberry Juice, Bioavailability, Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blackberry juice with 12% ethanol
Arm Type
Experimental
Arm Description
250 ml of blackberry juice freshly prepared with 250 g fresh blackberries, 80 ml alcohol beverage (38%) and 17 g sugar.
Arm Title
Blackberry juice
Arm Type
Experimental
Arm Description
250 ml of blackberry juice freshly prepared with 250 g fresh blackberries, 80 ml water and 17 g sugar.
Intervention Type
Dietary Supplement
Intervention Name(s)
Blackberry juice with 12% ethanol
Intervention Type
Dietary Supplement
Intervention Name(s)
Blackberry juice
Primary Outcome Measure Information:
Title
Plasma concentrations of anthocyanins and anthocyanins metabolites
Time Frame
At baseline and 15, 30, 60 and 120 minutes after juices consumption
Secondary Outcome Measure Information:
Title
Urinary concentrations of anthocyanins and anthocyanins metabolites
Time Frame
At baseline and 120 minutes after juices consumption
Title
Fecal concentrations of anthocyanins and anthocyanins metabolites
Time Frame
At baseline and at least 6 h after juices consumption
Title
Number of copies of bacterias presented in fecal samples
Time Frame
At baseline and at least 6 h after juices consumption
Title
Blood pressure measured in the left upper arm using an automatic blood pressure monitor
Time Frame
At baseline and 120 minutes after juices consumption
Title
Capillary blood glucose concentration
Time Frame
At baseline and 15, 30, 60 and 120 minutes after juices consumption
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women
Age 18-40 years
BMI>18 kg/m2
Willing and able to provide written consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conceição Calhau, PhD
Organizational Affiliation
CINTESIS - Faculty of Medicine of University of Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
CINTESIS - Faculty of Medicine of the University of Porto
City
Porto
ZIP/Postal Code
4200-450
Country
Portugal
12. IPD Sharing Statement
Learn more about this trial
Bioavailability of Blackberry Juice Anthocyanins
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