NCT02264561

Brief Summary

The purpose of this study is to determine whether caffeine improves attention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

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

September 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

September 24, 2014

Last Update Submit

April 7, 2015

Conditions

Attention

Outcome Measures

Primary Outcomes (1)

  • Attention test: milliseconds and index of stimulus sensitivity

    duration 10 days from screening to last visit (V2)

Secondary Outcomes (2)

  • Central Nervous System :response time.

    duration: 10 days from screening to last visit (V2)

  • Mood measures: Visual Analog scale.

    duration 10 days from screening to last visit V2

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Mannitol administered at visit 1 and at visit 2

Other: Food

caffeine

ACTIVE COMPARATOR

caffeine administered at visit 1 and at visit 2

Other: Food

Interventions

FoodOTHER

Active group

Also known as: Caffeine
Placebocaffeine

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Healthy male and female Aged 40-60 years

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Center for Human Drug Research

Leiden, CL, 2333, Netherlands

Location

MeSH Terms

Interventions

FoodCaffeine

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and BeveragesXanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2014

First Posted

October 15, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

NL(1)