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Bioavailability of Blackberry Juice Anthocyanins

NCT ID: NCT02613715

Last Updated: 2015-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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

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Overweight and Obesity Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Blackberry juice with 12% ethanol

250 ml of blackberry juice freshly prepared with 250 g fresh blackberries, 80 ml alcohol beverage (38%) and 17 g sugar.

Group Type EXPERIMENTAL

Blackberry juice with 12% ethanol

Intervention Type DIETARY_SUPPLEMENT

Blackberry juice

250 ml of blackberry juice freshly prepared with 250 g fresh blackberries, 80 ml water and 17 g sugar.

Group Type EXPERIMENTAL

Blackberry juice

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Blackberry juice with 12% ethanol

Intervention Type DIETARY_SUPPLEMENT

Blackberry juice

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Center for Health Technology and Services Research

OTHER

Sponsor Role collaborator

Vinoflavo

INDUSTRY

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Conceição Calhau, PhD

Role: PRINCIPAL_INVESTIGATOR

CINTESIS - Faculty of Medicine of University of Porto

Locations

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CINTESIS - Faculty of Medicine of the University of Porto

Porto, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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VINOFLAVO_01

Identifier Type: -

Identifier Source: org_study_id