The Effect of Caffeine in Elderly Citizen Following Eight Hour Abstinence From Caffeine Containing Drinks & Foods

Healthy Clinical Trial

Official title:

The Effect of Caffeine as Endurance Enhancing Drug in the Elderly Following Eight Hour Abstinence From Caffeine Containing Drinks and Foods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048515
• Other study ID #: MBJ-1
• Status: Completed
• Phase: Phase 4
• First received: January 12, 2010
• Last updated: January 12, 2010
• Start date: February 2005

Study information

• Verified date: January 2010
• Source: Herning Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elderly
• Healthy

Intervention

Drug:
• Caffeine
Caffeine capsule 6 mg/kg given 1 hour before test

Locations

Country	Name	City	State
Denmark	Surgical Research Department	Herning	Midtjylland

Sponsors (1)

Lead Sponsor	Collaborator
Herning Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. Epub 2005 Aug 4. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endurance measured on an ergometer bicycle		The tests started 1 h following placebo/caffeine	No
Secondary	Isometric endurance (arm flexion)		The tests started 1 h following placebo/caffeine	No
Secondary	Isometric maximum arm flexion strength		The tests started 1 h following placebo/caffeine	No
Secondary	Fatigue (Borg scale) during ergometer test		After 5 minutes biking and at exhaustion	No
Secondary	Postural stability		The tests started 1 h following placebo/caffeine	No
Secondary	Reaction time		The tests started 1 h following placebo/caffeine	No
Secondary	Walking speed		The tests started 1 h following placebo/caffeine	No
Secondary	Biochemistry: lactate, catecholamines, insulin, free fatty acids, glucose		Before intervention; before cycling; after 5 minutes of cycling; and at exhaustion	No
Secondary	Withdrawal symptoms		At the end of each test	Yes
Secondary	Side effects		At the end of each test	Yes