Bioavailability of Blackberry Juice Anthocyanins

NCT02613715 | Completed Phase 1

• 1 other identifier: VINOFLAVO_01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Healthy

Keywords

Flavonoids; Anthocyanins; Blackberry Juice; Bioavailability; Obesity

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of anthocyanins and anthocyanins metabolites

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

Secondary Outcomes (5)

• Urinary concentrations of anthocyanins and anthocyanins metabolites

  At baseline and 120 minutes after juices consumption

• Fecal concentrations of anthocyanins and anthocyanins metabolites

  At baseline and at least 6 h after juices consumption

• Number of copies of bacterias presented in fecal samples

  At baseline and at least 6 h after juices consumption

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

  At baseline and 120 minutes after juices consumption

• Capillary blood glucose concentration

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

Study Arms (2)

Blackberry juice with 12% ethanol

EXPERIMENTAL

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

Dietary Supplement: Blackberry juice with 12% ethanol

Blackberry juice

EXPERIMENTAL

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

Dietary Supplement: Blackberry juice

Interventions

Blackberry juice with 12% ethanol DIETARY_SUPPLEMENT

Blackberry juice with 12% ethanol

Blackberry juice DIETARY_SUPPLEMENT

Blackberry juice

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women
• Age 18-40 years
• BMI\>18 kg/m2
• Willing and able to provide written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Porto: lead
• Center for Health Technology and Services Research: collaborator
• Vinoflavo: collaborator

Study Sites (1)

CINTESIS - Faculty of Medicine of the University of Porto

Porto, 4200-450, Portugal

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Conceição Calhau, PhD

  CINTESIS - Faculty of Medicine of University of Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 24, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 24, 2015

Record last verified: 2015-10

Locations

PT (1)