Natural Antioxidant Ice-cream, Oxidative Stress and Vascular Function
Natural Antioxidant Ice-cream Acutely Reduces Oxidative Stress, Improves Vascular Function and Physical Performance in Healthy Subjects
1 other identifier
interventional
14
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 8, 2016
CompletedFirst Posted
Study publicly available on registry
February 18, 2016
CompletedFebruary 19, 2016
February 1, 2016
3 months
February 8, 2016
February 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Endothelial function
Endothelial function will be performed By Endopat2000 and FMD
Acute 2 hours
Study Arms (2)
Antioxidant Ice-cream
EXPERIMENTALNatural antioxidant Ice-cream
Control Ice-cream
PLACEBO COMPARATORNatural control ice-cream
Interventions
Eligibility Criteria
You may qualify if:
- healthy, non-smoking, volunteers
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 18614722BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Davide Francomano, MD
University of Roma La Sapienza
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Researcher
Study Record Dates
First Submitted
February 8, 2016
First Posted
February 18, 2016
Study Start
July 1, 2015
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
February 19, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share