HealthyPhase 4NCT01048515
The Effect of Caffeine in Elderly Citizen Following Eight Hour Abstinence From Caffeine Containing Drinks & Foods
A Phase 4 study testing Caffeine in people with Healthy and Elderly, run by Herning Hospital at 1 site in Denmark.
Trial summary
The study investigated the effect of caffeine on physical performance in healthy citizens aged over 70 years following eight hours of abstinence from caffeine containing drinks and foods. The main hypothesis was that 6 mg/kg caffeine would improve cycling endurance at 65% of expected maximal heart rate. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2005to Nov 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy elderly individuals aged over 70 years (Primarily those who previously have participated in an identical study with 48 hour caffeine abstinence)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Caffeine as Endurance Enhancing Drug in the Elderly Following Eight Hour Abstinence From Caffeine Containing Drinks and Foods
The study investigated the effect of caffeine on physical performance in healthy citizens aged over 70 years following eight hours of abstinence from caffeine containing drinks and foods. The main hypothesis was that 6 mg/kg caffeine would improve cycling endurance at 65% of expected maximal heart rate.
Read the 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.
- Being tested
- Caffeine
- Keywords
- Caffeine, Physiological Effects of Drugs, Central Nervous System Agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Also called Identical looking placebo capsule given 1 hour before test
Caffeine capsule 6 mg/kg given 1 hour before test
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | Not described Receives: Drug: Caffeine |
| Placebo | Placebo comparator | Not described Receives: Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance measured on an ergometer bicycle
Measured: The tests started 1 h following placebo/caffeine
Secondary outcomes (9)
Isometric endurance (arm flexion)
Measured: The tests started 1 h following placebo/caffeine
Isometric maximum arm flexion strength
Measured: The tests started 1 h following placebo/caffeine
Fatigue (Borg scale) during ergometer test
Measured: After 5 minutes biking and at exhaustion
Postural stability
Measured: The tests started 1 h following placebo/caffeine
Reaction time
Measured: The tests started 1 h following placebo/caffeine
Walking speed
Measured: The tests started 1 h following placebo/caffeine
Biochemistry: lactate, catecholamines, insulin, free fatty acids, glucose
Measured: Before intervention; before cycling; after 5 minutes of cycling; and at exhaustion
Withdrawal symptoms
Measured: At the end of each test
Side effects
Measured: At the end of each test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startFeb 2005
- Primary completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Martin B Jensen, MD, Ph.d., Principal investigator, Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048515
- Sponsor's protocol ID
- MBJ-1
- Status last verified
- Jan 2010
- First submitted
- 12 Jan 2010
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16081625Norager 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.
PubMed 16886964
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Caffeine as Endurance Enhancing Drug in the Elderly Following Eight Hour Abstinence From Caffeine Containing Drinks and Foods
- ClinicalTrials.gov ID
- NCT01048515
- Acronym / sponsor ID
- MBJ-1
- Keywords
- Caffeine, Physiological Effects of Drugs, Central Nervous System Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Nov 2005 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigated the effect of caffeine on physical performance in healthy citizens aged over 70 years following eight hours of abstinence from caffeine containing drinks and foods. The main hypothesis was that 6 mg/kg caffeine would improve cycling endurance at 65% of expected maximal heart rate.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Drug: Caffeine |
| Placebo | Placebo comparator | Drug: Caffeine |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Healthy elderly individuals aged over 70 years (Primarily those who previously have participated in an identical study with 48 hour caffeine abstinence)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaffeineAlso: Identical looking placebo capsule given 1 hour before testCaffeine capsule 6 mg/kg given 1 hour before test | Drug | Caffeine, Placebo |
Primary outcome
Endurance measured on an ergometer bicycle
Time frame: The tests started 1 h following placebo/caffeine
9 secondary outcomes
Isometric endurance (arm flexion)
Time frame: The tests started 1 h following placebo/caffeine
Isometric maximum arm flexion strength
Time frame: The tests started 1 h following placebo/caffeine
Fatigue (Borg scale) during ergometer test
Time frame: After 5 minutes biking and at exhaustion
Postural stability
Time frame: The tests started 1 h following placebo/caffeine
Reaction time
Time frame: The tests started 1 h following placebo/caffeine
Walking speed
Time frame: 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
Withdrawal symptoms
Time frame: At the end of each test
Side effects
Time frame: At the end of each test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Background: PubMed 16081625Norager 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.
- Background: PubMed 16886964Norager 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin B Jensen, MD, Ph.d. principal investigator
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caffeine in people with Healthy and Elderly, run by Herning Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance measured on an ergometer bicycle (time frame: The tests started 1 h following placebo/caffeine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01048515, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010.