NCT02544165

Brief Summary

The aim of this study was to investigate the difference in accumulation of AGEs (advanced glycation end-products) in the tissues of individuals who smoke in comparison with individuals who do not as well as of individuals who consume caffeine versus those who do not, and finally to examine the probable differences concerning participants' haemodynamic parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

2 months

First QC Date

August 22, 2015

Last Update Submit

September 4, 2015

Conditions

Hemodynamic InstabilitySkin and Subcutaneous Tissue Disorders

Keywords

smokingcaffeine intakehaemodynamic parametersAdvanced Glycation End Products (AGEs)Non-invasive measurements devices

Outcome Measures

Primary Outcomes (1)

  • Measurements of the haemodynamic parameters and accumulation of AGEs before smoking and before intake of caffeine

    Measurements of the haemodynamic parameters and accumulation of AGEs before smoking of one cigarette and consumption of 100 mg caffeine

    0 min

Secondary Outcomes (3)

  • Changes in the haemodynamic parameters and accumulation of AGEs after consuming 100 mg of caffeine

    60 min

  • Changes in the haemodynamic parameters and accumulation of AGEs after smoking of one cigarette

    60 min

  • Changes in the haemodynamic parameters and in the accumulation of AGEs after smoking of one cigarette and after consuming of 100 mg caffeine

    60 min

Study Arms (4)

Caffeine intake

EXPERIMENTAL

100mg of Caffeine intake

Dietary Supplement: caffeine intake

Cigarette smoking

EXPERIMENTAL

smoking of one cigarette

Other: cigarette smoking

Caffeine intake and Cigarette smoking

EXPERIMENTAL

100mg of Caffeine intake and smoking of one cigarette

Other: cigarette smokingOther: Caffeine intake and Cigarette smoking

Control group

NO INTERVENTION

no intervention group

Interventions

caffeine intakeDIETARY_SUPPLEMENT

The subjects of this group should intake 100 mg of caffeine after the first measurement of haemodynamic parameters with the Finometer device and after the first measurement of the advanced glycation end products accumulation with AgeReader device.

Caffeine intake
cigarette smokingOTHER

The subjects of this group should smoke one cigarette after the first measurement of haemodynamic parameters with the Finometer device and after the first measurement of the advanced glycation end products accumulation with AgeReader device.

Caffeine intake and Cigarette smokingCigarette smoking
Caffeine intake and Cigarette smokingOTHER

The subjects of this group should smoke one cigarette and should consume 100 mg of caffeine after the first measurement of haemodynamic parameters with the Finometer device and after the first measurement of the advanced glycation end products accumulation with AgeReader device.

Caffeine intake and Cigarette smoking

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals who smoke ≥ 10 cigarettes per day
  • Healthy non smoking individuals consuming caffeine on daily basis
  • Healthy individuals, smoking and consuming caffeine on daily basis

You may not qualify if:

  • Individuals suffering from any chronic disease (diabetes mellitus, cardiovascular diseases, etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technological Educational Institute of Sterea Ellada

Lamia, 35100, Greece

Location

MeSH Terms

Conditions

Skin DiseasesSmoking

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesBehavior

Study Officials

  • Anna Deltsidou, PhD

    Technological Educational Institute of Athens, Greece

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 22, 2015

First Posted

September 9, 2015

Study Start

November 1, 2012

Primary Completion

January 1, 2013

Study Completion

June 1, 2014

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

GR(1)