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

NCT01048515 | Completed Phase 4 DMC

• 1 other identifier: MBJ-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Elderly

Keywords

Caffeine; Physiological Effects of Drugs; Central Nervous System Agents

Outcome Measures

Primary Outcomes (1)

• Endurance measured on an ergometer bicycle

  The tests started 1 h following placebo/caffeine

Secondary Outcomes (9)

• Isometric endurance (arm flexion)

  The tests started 1 h following placebo/caffeine

• Isometric maximum arm flexion strength

  The tests started 1 h following placebo/caffeine

• Fatigue (Borg scale) during ergometer test

  After 5 minutes biking and at exhaustion

• Postural stability

  The tests started 1 h following placebo/caffeine

• Reaction time

  The tests started 1 h following placebo/caffeine

Study Arms (2)

Caffeine

EXPERIMENTAL

Drug: Caffeine

Placebo

PLACEBO COMPARATOR

Drug: Caffeine

Interventions

Caffeine DRUG

Caffeine capsule 6 mg/kg given 1 hour before test

Also known as: Identical looking placebo capsule given 1 hour before test

Caffeine; Placebo

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Healthy elderly individuals aged over 70 years (Primarily those who previously have participated in an identical study with 48 hour caffeine abstinence)

You may not qualify if:

• 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

Sponsors & Collaborators

• Herning Hospital: lead

Study Sites (1)

Surgical Research Department

Herning, Central Jutland, 7400, Denmark

Location

Related 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. doi: 10.1152/japplphysiol.00309.2005. Epub 2005 Aug 4.

  PMID: 16081625 BACKGROUND

• 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.

  PMID: 16886964 BACKGROUND

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Martin B Jensen, MD, Ph.d.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: February 1, 2005
• Primary Completion: November 1, 2005
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

DK (1)