Natural Antioxidant Ice-cream, Oxidative Stress and Vascular Function
Primary Purpose
Vascular System Injuries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Antioxidant ice-cream
Control Ice-cream
Sponsored by
About this trial
This is an interventional treatment trial for Vascular System Injuries
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Antioxidant Ice-cream
Control Ice-cream
Arm Description
Natural antioxidant Ice-cream
Natural control ice-cream
Outcomes
Primary Outcome Measures
Endothelial function
Endothelial function will be performed By Endopat2000 and FMD
Secondary Outcome Measures
Full Information
NCT ID
NCT02685163
First Posted
February 8, 2016
Last Updated
February 18, 2016
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT02685163
Brief Title
Natural Antioxidant Ice-cream, Oxidative Stress and Vascular Function
Official Title
Natural Antioxidant Ice-cream Acutely Reduces Oxidative Stress, Improves Vascular Function and Physical Performance in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular System Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antioxidant Ice-cream
Arm Type
Experimental
Arm Description
Natural antioxidant Ice-cream
Arm Title
Control Ice-cream
Arm Type
Placebo Comparator
Arm Description
Natural control ice-cream
Intervention Type
Other
Intervention Name(s)
Antioxidant ice-cream
Intervention Description
Narutal Antioxidant ice-cream
Intervention Type
Other
Intervention Name(s)
Control Ice-cream
Intervention Description
Natural Control Ice-cream
Primary Outcome Measure Information:
Title
Endothelial function
Description
Endothelial function will be performed By Endopat2000 and FMD
Time Frame
Acute 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davide Francomano, MD
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18614722
Citation
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0025474/
Description
Reference link
Learn more about this trial
Natural Antioxidant Ice-cream, Oxidative Stress and Vascular Function
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