NCT04891393

Brief Summary

This study evaluates the effects of orally ingested, commercially available, coffee (3 mg/kg of caffeine) on the excitability of human spinal motoneurons of the lower leg.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

May 11, 2021

Last Update Submit

April 7, 2022

Conditions

Healthy

Keywords

Motor NeuronExcitabilityCaffeine

Outcome Measures

Primary Outcomes (1)

  • Motoneuron excitability (Delta-f)

    Changes in motorneuron excitability, as quantified by Delta-F values. A paired motor unit technique will be utilized (Gorassini et al., 2002). (Typically, these values range from -5 to +10).

    Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention

Secondary Outcomes (3)

  • Motor Unit Discharge Rate

    Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention

  • Coherence

    Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention

  • Motor Unit Recruitment Threshold

    Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention

Study Arms (2)

Caffeine

EXPERIMENTAL

Single-dose, orally ingested, instant coffee.

Dietary Supplement: Coffee

Inactive Placebo

PLACEBO COMPARATOR

Single-dose, orally ingested, instant decaffeinated coffee (equal weight to intervention dose).

Dietary Supplement: Decaffeinated coffee

Interventions

CoffeeDIETARY_SUPPLEMENT

Starbucks brand "Via" instant coffee. (Caffeine Content: 3 mg / kg)

Caffeine
Decaffeinated coffeeDIETARY_SUPPLEMENT

Starbucks brand "Via" instant decaffeinated coffee. (Caffeine Content: 15 - 25 mg)

Inactive Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ● Between 18 and 70 years of age

You may not qualify if:

  • Significant neurological or orthopedic injuries, which may limit volitional torque generation in the tested muscles.
  • Significant change in the subjects' health or treatment in the past month.
  • Known history of cardiovascular pathology (to include: uncontrolled hypertension, cardiac arrhythmias) or medical restrictions to caffeine ingestion.
  • Allergies or dislike of coffee.
  • Women who are pregnant will be excluded due to potential forces at trunk from pelvic safety harness and due to potential adverse effects of caffeine on the developing child.
  • Women who are breastfeeding will be excluded due potential adverse effects on the breastfeeding infant from caffeine administration.
  • Adults unable to consent, minors, pregnant women, and prisoners will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Related Publications (3)

  • Gorassini M, Yang JF, Siu M, Bennett DJ. Intrinsic activation of human motoneurons: possible contribution to motor unit excitation. J Neurophysiol. 2002 Apr;87(4):1850-8. doi: 10.1152/jn.00024.2001.

    PMID: 11929906BACKGROUND

  • Rosenberg JR, Amjad AM, Breeze P, Brillinger DR, Halliday DM. The Fourier approach to the identification of functional coupling between neuronal spike trains. Prog Biophys Mol Biol. 1989;53(1):1-31. doi: 10.1016/0079-6107(89)90004-7. No abstract available.

    PMID: 2682781BACKGROUND

  • Farina D, Negro F. Accessing the neural drive to muscle and translation to neurorehabilitation technologies. IEEE Rev Biomed Eng. 2012;5:3-14. doi: 10.1109/RBME.2012.2183586.

    PMID: 23231985BACKGROUND

MeSH Terms

Interventions

Coffee

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Christopher Thompson, PT, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
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

May 11, 2021

First Posted

May 18, 2021

Study Start

June 1, 2021

Primary Completion

March 28, 2022

Study Completion

March 28, 2022

Last Updated

April 8, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)