Natural Antioxidant Ice-cream, Oxidative Stress and Vascular Function

NCT ID: NCT02685163

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-12-31

Brief Summary

Formation of reactive oxygen species (ROS) contributes to pathogenesis and progression of several diseases. Polyphenols, have been shown to be beneficial against ROS.

This study evaluate the effects of a natural antioxidant ice-cream,rich in polyphenols, on oxidative stress, vascular function and physical performance. In this controlled, single-blind cross-over study, 14 healthy subjects were randomized to assume 100 mg of antioxidant ice-cream consisting of dark cocoa powder, extract of hazelnut and green tea, or milk chocolate ice-cream (control ice-cream). Subjects were studied at baseline and two hours after the ingestion of the ice-creams. Serum polyphenols, antioxidant status (ferric reducing ability of plasma, FRAP), NO bioavailability (NOx), markers of oxidative stress (D-Roms and H2O2), endothelium function (FMD and RHI) and exercise tolerance (Stress Test) with measurement of the double product were assessed.

Detailed Description

14 healthy, non-smoking, volunteers (7 males ), aged between 20 and 40 years were enrolled. The study was randomized, placebo-controlled. After enrollment, 3 days before entering the study, all subjects performed an exercise stress test. They were then randomly allocated to the treatment sequence with 100 mg of natural anti-oxidant ice cream or milk chocolate ice-cream (control icecream) in a cross-over single-blind design. There was 1 week wash-out between 2 phases of the study.

Markers of oxidative stress (D-ROMs and H2O2); serum antioxidant status (FRAP), NO bioavailability (NOx), the endothelium flow-mediated vasodilation (FMD and the RHI by Endopat 2000) were evaluated in fasting condition at baseline (time 0) and 2 hours after the ingestion of the anti-oxidant or control ice-creams. The exercise stress test was performed before randomization and 2 hours after each ice-cream meal test. In both experiments, the ice-cream was consumed within 10 min.

Each subject was asked to refrain from any kind of medication, diet integrators, intensive physical activity and to avoid consumption of polyphenols rich foods, such cocoa-containing products, red wine, tea within the previously 2 weeks. All participants gave written informed consent, and the study was approved by the Medical Ethics Committee of La Sapienza University of Rome (Rif: 3727, Prot: 2325/15).

Conditions

Vascular System Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Antioxidant Ice-cream

Natural antioxidant Ice-cream

Group Type: EXPERIMENTAL

Antioxidant ice-cream

Intervention Type: OTHER

Narutal Antioxidant ice-cream

Control Ice-cream

Natural control ice-cream

Group Type: PLACEBO_COMPARATOR

Control Ice-cream

Intervention Type: OTHER

Natural Control Ice-cream

Interventions

Antioxidant ice-cream

Narutal Antioxidant ice-cream

Intervention Type: OTHER

Control Ice-cream

Natural Control Ice-cream

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• healthy, non-smoking, volunteers

Exclusion Criteria

• Assumption of any kind of medication, diet integrators, intensive physical activity and to avoid consumption of polyphenols rich foods, tea within the previously 2 weeks.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Davide Francomano

PhD Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Davide Francomano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

References

Hooper L, Kroon PA, Rimm EB, Cohn JS, Harvey I, Le Cornu KA, Ryder JJ, Hall WL, Cassidy A. Flavonoids, flavonoid-rich foods, and cardiovascular risk: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2008 Jul;88(1):38-50. doi: 10.1093/ajcn/88.1.38.

Reference Type: BACKGROUND

PMID: 18614722 (View on PubMed)

Other Identifiers

Rif: 3727, Prot: 2325/15

Identifier Type: -

Identifier Source: org_study_id