Clinical trial NCT02613715: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight and Obesity
Healthy
Keywords: Flavonoids
Anthocyanins
Blackberry Juice
Bioavailability
Obesity
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Center for Health Technology and Services Research
name: Vinoflavo
First posted: 2015-11-24
Enrollment: 18
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 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.

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

Primary outcomes:
measure: Plasma concentrations of anthocyanins and anthocyanins metabolites
timeFrame: At baseline and 15, 30, 60 and 120 minutes after juices consumption
Secondary outcomes:
measure: Urinary concentrations of anthocyanins and anthocyanins metabolites
timeFrame: At baseline and 120 minutes after juices consumption
measure: Fecal concentrations of anthocyanins and anthocyanins metabolites
timeFrame: At baseline and at least 6 h after juices consumption
measure: Number of copies of bacterias presented in fecal samples
timeFrame: At baseline and at least 6 h after juices consumption
measure: Blood pressure measured in the left upper arm using an automatic blood pressure monitor
timeFrame: At baseline and 120 minutes after juices consumption
measure: Capillary blood glucose concentration
timeFrame: At baseline and 15, 30, 60 and 120 minutes after juices consumption
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: CINTESIS - Faculty of Medicine of the University of Porto
Study officials:
affiliation: CINTESIS - Faculty of Medicine of University of Porto
name: Conceição Calhau, PhD
role: PRINCIPAL_INVESTIGATOR
References: