NCT01492114

Brief Summary

This research will investigate the hypothesis that resveratrol when given orally to healthy adult smokers induces a decrease in the inflammatory and oxidative mediators which characterize the low-grade systemic inflammatory state and the oxidants-antioxidants imbalance of tobacco users.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

7 months

First QC Date

December 12, 2011

Last Update Submit

July 6, 2012

Conditions

Chronic Subclinic InflammationRedox Status

Keywords

C-reactive proteinResveratrolRedox index

Outcome Measures

Primary Outcomes (1)

  • C-reactive protein

    To evaluate before-after changes in circulating concentrations of C-reactive protein (CRP), an inflammation marker, in smokers submitted to resveratrol supplementation when compared to smokers treated with placebo

    At baseline and every 30 days for three months

Secondary Outcomes (9)

  • TAS (total antioxidant status)

    At baseline and every 30-days for three months

  • 4-hydroxynonenal

    At baseline and after 30-days for three months

  • nitrotyrosine

    At baseline and every 30-days for three months

  • endothelial nitric oxide synthase (eNOS)-polymorphism

    At baseline and every 30-days for three months

  • superoxide dismutase (SOD2)-polymorphism

    At baseline and every 30-days for three months

  • +4 more secondary outcomes

Study Arms (2)

Resveratrol first

EXPERIMENTAL

Subjects in the group "resveratrol first" will be submitted to: 30 days of treatment with Transmax (resveratrol, 500 mg, Biotivia Bioceuticals LLC), one tablet/day in the morning at fasting; then to 30 days of wash-out (no supplementation), and then to 30 days of treatment with placebo (one tablet/day in the morning at fasting).

Dietary Supplement: Resveratrol

Placebo first

ACTIVE COMPARATOR

Subjects in the group "Placebo first" will be submitted to: 30 days of treatment with placebo, one tablet/day in the morning at fasting; than to 30 days of wash-out (no supplementation), and then to 30 days of treatment with Transmax (resveratrol, 500 mg) (one tablet/day in the morning at fasting).

Dietary Supplement: resveratrol

Interventions

resveratrolDIETARY_SUPPLEMENT

Subjects in the group "resvetarol first" will be submitted to: 30 days of treatment with Transmax (resveratrol, 500 mg, Biotivia Bioceuticals LLC), one tablet/day in the morning at fasting; then to 30 days of wash-out (no supplementation), and then to 30 days of treatment with placebo (one tablet/day in the morning at fasting).

Resveratrol first

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 20-50 years
  • actual smoking (≥5 cigarettes/die)
  • mean alcohol consumption \<30g/day
  • absence of known hyperglycaemia, hypertension, cardiovascular disease, impaired renal function, liver disease, or any other systemic conditions -no use of any drug -oestrogen excluded-
  • not being on a particular diet and/or vitamin or other nutrient or integrator supplementation during the least 6-months

You may not qualify if:

  • actual pregnancy -known hyperglycaemia, hypertension, cardiovascular disease, impaired renal function, liver disease, or any other systemic chronic or acute conditions, use of any drug -oestrogen excluded-
  • being on a particular diet and/or vitamin or other nutrient or integrator supplementation during the last six months
  • mean alcohol consumption ≥30g/day
  • body mass index (BMI)\>30 kg/m2
  • subject unable to give his/her informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simona Bo

Turin, Turin, 10126, Italy

Location

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Simona Bo, MD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Department of Internal Medicine

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 14, 2011

Study Start

July 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

IT(1)