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Completed

NCT Number: NCT02613715

Bioavailability of Blackberry Juice Anthocyanins

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CINTESIS - Faculty of Medicine of the University of Porto

Porto, 4200-450, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blackberry juice with 12% ethanol

Dietary Supplement

Blackberry juice

Dietary Supplement

Primary outcomes

  1. Plasma concentrations of anthocyanins and anthocyanins metabolites

    Time frame: At baseline and 15, 30, 60 and 120 minutes after juices consumption

Secondary outcomes

  1. Urinary concentrations of anthocyanins and anthocyanins metabolites

    Time frame: At baseline and 120 minutes after juices consumption

  2. Fecal concentrations of anthocyanins and anthocyanins metabolites

    Time frame: At baseline and at least 6 h after juices consumption

  3. Number of copies of bacterias presented in fecal samples

    Time frame: At baseline and at least 6 h after juices consumption

  4. Blood pressure measured in the left upper arm using an automatic blood pressure monitor

    Time frame: At baseline and 120 minutes after juices consumption

  5. Capillary blood glucose concentration

    Time frame: At baseline and 15, 30, 60 and 120 minutes after juices consumption

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

  • Center for Health Technology and Services Research
  • Vinoflavo

Registry information

Official study title

Influence of Ethanol in the Bioavailability of Blackberry Juice Anthocyanins in Normal Weight and Overweight/Obese Adults

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2015
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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