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

NCT ID: NCT01048515

Last Updated: 2010-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28

Brief 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.

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.

Conditions

Healthy; Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Caffeine

Group Type: EXPERIMENTAL

Caffeine

Intervention Type: DRUG

Caffeine capsule 6 mg/kg given 1 hour before test

Placebo

Group Type: PLACEBO_COMPARATOR

Caffeine

Intervention Type: DRUG

Caffeine capsule 6 mg/kg given 1 hour before test

Interventions

Caffeine

Caffeine capsule 6 mg/kg given 1 hour before test

Intervention Type: DRUG

Other Intervention Names

Identical looking placebo capsule given 1 hour before test

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Herning Hospital

OTHER

Sponsor Role: lead

Responsible Party

Surgical Research Department, Herning Hospital, DK-7400 Herning

Principal Investigators

Martin B Jensen, MD, Ph.d.

Role: PRINCIPAL_INVESTIGATOR

Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Locations

Surgical Research Department

Herning, Central Jutland, Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 16081625 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16886964 (View on PubMed)

Other Identifiers

MBJ-1

Identifier Type: -

Identifier Source: org_study_id