CINTESIS - Faculty of Medicine of the University of Porto
Porto, 4200-450, Portugal
NCT Number: NCT02613715
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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Notify Me18 year–40 year
All sexes
Interventional
Phase 1
Porto, 4200-450, Portugal
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At baseline and 15, 30, 60 and 120 minutes after juices consumption
Time frame: At baseline and 120 minutes after juices consumption
Time frame: At baseline and at least 6 h after juices consumption
Time frame: At baseline and at least 6 h after juices consumption
Time frame: At baseline and 120 minutes after juices consumption
Time frame: At baseline and 15, 30, 60 and 120 minutes after juices consumption
Universidade do Porto
Other
Influence of Ethanol in the Bioavailability of Blackberry Juice Anthocyanins in Normal Weight and Overweight/Obese Adults
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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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