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Bioavailability of Blackberry Juice Anthocyanins

U

Universidade do Porto

Status and phase

Completed
Phase 1

Conditions

Healthy
Overweight and Obesity

Treatments

Dietary Supplement: Blackberry juice with 12% ethanol
Dietary Supplement: Blackberry juice

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02613715
VINOFLAVO_01

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

18 participants in 2 patient groups

Blackberry juice with 12% ethanol
Experimental group
Description:
250 ml of blackberry juice freshly prepared with 250 g fresh blackberries, 80 ml alcohol beverage (38%) and 17 g sugar.
Treatment:
Dietary Supplement: Blackberry juice with 12% ethanol
Blackberry juice
Experimental group
Description:
250 ml of blackberry juice freshly prepared with 250 g fresh blackberries, 80 ml water and 17 g sugar.
Treatment:
Dietary Supplement: Blackberry juice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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