- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01048515
The Effect of Caffeine in Elderly Citizen Following Eight Hour Abstinence From Caffeine Containing Drinks & Foods
The Effect of Caffeine as Endurance Enhancing Drug in the Elderly Following Eight Hour Abstinence From Caffeine Containing Drinks and Foods
Study Overview
Detailed Description
It is well documented that caffeine ingestion increases the endurance of young people exercising at 60%-85% of their maximal oxygen uptake (13;15;47). It also seems to improve endurance as measured by repeated sub-maximal isometric contraction (42), and decreases the rate of perceived exertion during exercise (6;9;46). Typically, doses of approximately 6 mg/kg caffeine were used in these studies.
With a growing number of elderly with a physical active lifestyle and many elderly participating in rehabilitation programs the endurance enhancing effect of caffeine is of increasing interest in this age group. We therefore conducted a study of healthy 75 year old citizens to investigate whether 6 mg/kg caffeine improved physical performance and reduced the perceived effort during work in healthy citizens aged ≥ 70 years. The main hypothesis was that caffeine would improve cycling endurance at 65% of expected maximal heart rate. The study showed that compared to placebo caffeine increased endurance by 25 % (p<0.0001) and isometric sub-maximal strength with 54 % (p<0.0001), reduced perceived exertion after 5 minutes of biking by 11 % (p=0.002), but in 21 of 30 participants there was reduced postural stability (with eyes open). In the above described study participants abstained from caffeine containing drinks and foods for 48 hours prior to each test. Half of the participants reported withdrawal symptoms. Such a long caffeine abstinence period would infer with daily life for many people. We therefore invited the participants from the above study to a repetition of the above study to test whether similar results would be obtained if participants only abstained from caffeine containing drinks and foods for 8 hours prior to each test.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Midtjylland
-
Herning, Midtjylland, Denmark, 7400
- Surgical Research Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy elderly individuals aged over 70 years (Primarily those who previously have participated in an identical study with 48 hour caffeine abstinence)
Exclusion Criteria:
- Dementia or invalidating psychiatric disease
- General debility, angina, or other diseases that would render participation in the test program impossible
- Treatment with beta receptor blocking drugs, calcium-channel blocking drugs, digitalis, or nitroglycerine
- Acute disease and injury
- Diabetes
- Conditions that would contraindicate caffeine ingestion or participation in the test program
- Treatment with medication that interacts with caffeine
- Ingestion of caffeine containing drinks and foods 8 hours before each session
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Caffeine capsule 6 mg/kg given 1 hour before test
Other Names:
|
Experimental: Caffeine
|
Caffeine capsule 6 mg/kg given 1 hour before test
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endurance measured on an ergometer bicycle
Time Frame: The tests started 1 h following placebo/caffeine
|
The tests started 1 h following placebo/caffeine
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Isometric endurance (arm flexion)
Time Frame: The tests started 1 h following placebo/caffeine
|
The tests started 1 h following placebo/caffeine
|
Isometric maximum arm flexion strength
Time Frame: The tests started 1 h following placebo/caffeine
|
The tests started 1 h following placebo/caffeine
|
Fatigue (Borg scale) during ergometer test
Time Frame: After 5 minutes biking and at exhaustion
|
After 5 minutes biking and at exhaustion
|
Postural stability
Time Frame: The tests started 1 h following placebo/caffeine
|
The tests started 1 h following placebo/caffeine
|
Reaction time
Time Frame: The tests started 1 h following placebo/caffeine
|
The tests started 1 h following placebo/caffeine
|
Walking speed
Time Frame: The tests started 1 h following placebo/caffeine
|
The tests started 1 h following placebo/caffeine
|
Biochemistry: lactate, catecholamines, insulin, free fatty acids, glucose
Time Frame: Before intervention; before cycling; after 5 minutes of cycling; and at exhaustion
|
Before intervention; before cycling; after 5 minutes of cycling; and at exhaustion
|
Withdrawal symptoms
Time Frame: At the end of each test
|
At the end of each test
|
Side effects
Time Frame: At the end of each test
|
At the end of each test
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin B Jensen, MD, Ph.d., Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Publications and helpful links
General Publications
- Norager CB, Jensen MB, Madsen MR, Laurberg S. Caffeine improves endurance in 75-yr-old citizens: a randomized, double-blind, placebo-controlled, crossover study. J Appl Physiol (1985). 2005 Dec;99(6):2302-6. doi: 10.1152/japplphysiol.00309.2005. Epub 2005 Aug 4.
- Norager CB, Jensen MB, Weimann A, Madsen MR. Metabolic effects of caffeine ingestion and physical work in 75-year old citizens. A randomized, double-blind, placebo-controlled, cross-over study. Clin Endocrinol (Oxf). 2006 Aug;65(2):223-8. doi: 10.1111/j.1365-2265.2006.02579.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MBJ-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Caffeine
-
Southern Illinois University CarbondaleCompleted
-
Sharp HealthCareCompletedCaffeineUnited States
-
University of TorontoCanadian Institutes of Health Research (CIHR); Nutrigenomix Inc.Unknown
-
Pennington Biomedical Research CenterCompletedHealthy VolunteersUnited States
-
Vienna Institute for Research in Ocular SurgeryUnknown
-
Seoul St. Mary's HospitalCompletedApnea of Prematurity | Caffeine | PretermKorea, Republic of
-
University of ExeterCompleted
-
David Grant U.S. Air Force Medical CenterWithdrawnCardiovascular InjuryUnited States
-
St. Mary's University, TwickenhamNot yet recruiting
-
Escola Superior de Tecnologia da Saúde de CoimbraCompleted