EIMD Mechanisms Causing Force Loss

NCT02125643 | Terminated Phase 1

• 1 other identifier: 4088
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

We have hypothesized: 1) Caffeine will increase maximal voluntary strength compared to placebo in undamaged muscle. 2) Caffeine will increase muscle activation compared to placebo in undamaged muscle. 3) Caffeine will enhance spinal excitability (indicated by an enhanced H-reflex) compared to placebo in undamaged muscle. 4) Caffeine will raise the pressure-pain threshold (indicating decreased pain sensitivity) in the calf muscle compared to placebo in undamaged muscle. 5) Caffeine will reduce the amount of low-frequency fatigue, indicated by an enhanced 20-100 hertz strength ratio, compared to placebo in undamaged muscle. 6) Caffeine will increase maximal voluntary strength compared to placebo in damaged muscle. 7) Caffeine will increase muscle activation compared to placebo in damaged muscle. 8) Caffeine will enhance spinal excitability (indicated by an enhanced H-reflex) compared to placebo in damaged muscle. 9) Caffeine will raise the pressure-pain threshold (indicating decreased pain sensitivity) in the calf muscle compared to placebo in damaged muscle. 10) Caffeine will reduce the amount of low-frequency fatigue, indicated by an enhanced 20-100 hertz strength ratio, compared to placebo in damaged muscle. The proposed research will determine the effects of a 5mg/kg body weight dose of caffeine on muscular strength, activation, H-reflex function, and excitation-contraction coupling before and after exercise-induced muscle damage. The long term objectives are to gain a better understanding of caffeine and its affects following exercise-induced muscle damage allowing us to understand how caffeine is mechanistically interacting with functions of the body.

Conditions

Healthy

Keywords

Exercise-induced muscle damage; Caffeine; Maximal voluntary strength

Outcome Measures

Primary Outcomes (1)

• change in maximal voluntary strength

  Measure for maximal voluntary strength is in kilograms (kg) Change in maximal voluntary strength between base line and 24 hours, base line and 48 hours, and 24 and 48 hours - after ingesting caffeine/placebo in a counterbalanced manner in the undamaged state Change in maximal voluntary strength between base line and 24 hours, base line and 48 hours, and 24 and 48 hours - after ingesting caffeine/placebo in a counterbalanced manner following damaging protocol

  Base line then 24 and 48 hours after ingesting caffeine/placebo in a counterbalanced manner in the undamaged state and then 24 and 48 hours after ingesting caffeine/placebo in a counterbalanced manner following damaging protocol

Secondary Outcomes (7)

• change in h-reflex

  Base line then 24 and 48 hours after ingesting caffeine/placebo in a counterbalanced manner in the undamaged state and then 24 and 48 hours after ingesting caffeine/placebo in a counterbalanced manner following damaging protocol

• change in 20:100 hertz force ratio

  Base line then 24 and 48 hours after ingesting caffeine/placebo in a counterbalanced manner in the undamaged state and then 24 and 48 hours after ingesting caffeine/placebo in a counterbalanced manner following damaging protocol

• change in pain pressure threshold in the calf

  Base line then 24 and 48 hours after ingesting caffeine/placebo in a counterbalanced manner in the undamaged state and then 24 and 48 hours after ingesting caffeine/placebo in a counterbalanced manner following damaging protocol

• change in muscle activation

  Base line then 24 and 48 hours after ingesting caffeine/placebo in a counterbalanced manner in the undamaged state and then 24 and 48 hours after ingesting caffeine/placebo in a counterbalanced manner following damaging protocol

• change in the pain visual analog scales

  Base line then 24 and 48 hours after ingesting caffeine/placebo in a counterbalanced manner in the undamaged state and then 24 and 48 hours after ingesting caffeine/placebo in a counterbalanced manner following damaging protocol

Study Arms (2)

Caffeine Pill

ACTIVE COMPARATOR

The caffeine will be administered.

Drug: Caffeine

Placebo/Flour Pill

PLACEBO COMPARATOR

The flour will be administered.

Other: Flour

Interventions

Caffeine DRUG

Also known as: 1,3,7-trimethyl-1H-purine-2,6(3H,7H)-dione 3,7-dihydro-1,3,7-trimethyl-1H-purine-2,6-dione, Vivarin, Cafcit, Alert

Caffeine Pill

Flour OTHER

Flour will be administered as the placebo.

Placebo/Flour Pill

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age range of 18-35 years of age
• males and females who do not have a history of orthopedic injuries of the hip knee, and/or leg
• Participants must be engaged in some form of physical activity on at least 3 days each week

You may not qualify if:

• An answer of "yes" to any of the seven questions on the physical activity readiness questionnaire (PAR-Q)
• Average daily consumption of more than 40mg of caffeine per day as determined by the 2 week caffeine recall questionnaire
• Use of any type of prescription psychiatric or prescription or over-the-counter pain medication
• An answer of "yes" to questions 1,2,8, and 15-22 on the rhabdomyolysis screening questionnaire
• An answer of "yes" on questions 3,4,6,7,8, 11,12, and 13 if the follow up information indicates any type of medication, drug, supplement, illness, and/or dietary need that could affect pain sensitivity or the risk of dehydration. Determinations will be made on a participant-by-participant basis depending on the answers provided
• An answer of "yes" on question 24 indicating a previous adverse reaction to caffeine consumption
• Resting systolic blood pressure \>140 mmHg and/or resting diastolic blood pressure \>90 mmHg
• Pregnancy or suspicion of pregnancy.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Sensory and Muscle Function Lab 7

Norman, Oklahoma, 73072, United States

Location

Related Publications (8)

• Ploutz-Snyder LL, Giamis EL, Formikell M, Rosenbaum AE. Resistance training reduces susceptibility to eccentric exercise-induced muscle dysfunction in older women. J Gerontol A Biol Sci Med Sci. 2001 Sep;56(9):B384-90. doi: 10.1093/gerona/56.9.b384.

  PMID: 11524439 BACKGROUND

• Clarkson PM, Sayers SP. Etiology of exercise-induced muscle damage. Can J Appl Physiol. 1999 Jun;24(3):234-48. doi: 10.1139/h99-020.

  PMID: 10364418 RESULT

• Warren GL, Ingalls CP, Lowe DA, Armstrong RB. What mechanisms contribute to the strength loss that occurs during and in the recovery from skeletal muscle injury? J Orthop Sports Phys Ther. 2002 Feb;32(2):58-64. doi: 10.2519/jospt.2002.32.2.58.

  PMID: 11838581 RESULT

• Allen DG. Eccentric muscle damage: mechanisms of early reduction of force. Acta Physiol Scand. 2001 Mar;171(3):311-9. doi: 10.1046/j.1365-201x.2001.00833.x.

  PMID: 11412143 RESULT

• Balnave CD, Allen DG. Intracellular calcium and force in single mouse muscle fibres following repeated contractions with stretch. J Physiol. 1995 Oct 1;488 ( Pt 1)(Pt 1):25-36. doi: 10.1113/jphysiol.1995.sp020943.

  PMID: 8568662 RESULT

• Balnave CD, Davey DF, Allen DG. Distribution of sarcomere length and intracellular calcium in mouse skeletal muscle following stretch-induced injury. J Physiol. 1997 Aug 1;502 ( Pt 3)(Pt 3):649-59. doi: 10.1111/j.1469-7793.1997.649bj.x.

  PMID: 9279815 RESULT

• Meyers BM, Cafarelli E. Caffeine increases time to fatigue by maintaining force and not by altering firing rates during submaximal isometric contractions. J Appl Physiol (1985). 2005 Sep;99(3):1056-63. doi: 10.1152/japplphysiol.00937.2004. Epub 2005 May 5.

  PMID: 15879163 RESULT

• Nosaka K, Newton M. Concentric or eccentric training effect on eccentric exercise-induced muscle damage. Med Sci Sports Exerc. 2002 Jan;34(1):63-9. doi: 10.1097/00005768-200201000-00011.

  PMID: 11782649 RESULT

MeSH Terms

Interventions

Caffeine; caffeine citrate; Flour

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Christopher Black, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 29, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 5, 2017

Record last verified: 2017-06

Locations

US (1)