HealthyNCT04891393
The Effects of Caffeine on Human Spinal Motoneurons
A study testing Coffee and Decaffeinated coffee in people with Healthy, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Coffee and Decaffeinated coffee
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 28 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ● Between 18 and 70 years of age
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Recently, it has been shown that human spinal motoneurons do not simply act as a binary control system. Instead, they are regulated by intrinsic properties that can elicit lingering effects on the descending motoneuron. Caffeine, one of the world's most popular over-the-counter supplements, can potentially augment these characteristics of motoneurons. Using decomposition software and non-invasive, high-density surface electromyography, it is possible to extract the characteristics of these motoneurons. This project will utilize a double-blind, inactive-placebo controlled, crossover design study to examine and quantify the effects of caffeine on motoneuron excitability.
- Conditions
- Healthy
- Being tested
- Coffee, Decaffeinated coffee
- Keywords
- Motor Neuron, Excitability, Caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoffeeDietary supplement
Starbucks brand "Via" instant coffee. (Caffeine Content: 3 mg / kg)
Decaffeinated coffeeDietary supplement
Starbucks brand "Via" instant decaffeinated coffee. (Caffeine Content: 15 - 25 mg)
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | Single-dose, orally ingested, instant coffee. Receives: Dietary Supplement: Coffee |
| Inactive Placebo | Placebo comparator | Single-dose, orally ingested, instant decaffeinated coffee (equal weight to intervention dose). Receives: Dietary Supplement: Decaffeinated coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
Secondary outcomes (3)
Motor Unit Discharge Rate
Changes in motor unit discharge rate. This is a single value that ranges from, approximately, 0 to 30.
Measured: Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
Coherence
Changes in coherence values. Coherence provides a normalized value of the strength of correlation in the frequency domain. The magnitude of the correlation of the Fourier transforms of two spike trains is squared producing a value between 0 and 1, with 1 corresponding to a perfect linear prediction at a particular frequency (Rosenberg et al., 1989). This will be calculated using the composite spike train (Negro \& Farina, 2012) and, finally, z-transformed to allow for between-trial comparisons.
Measured: Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
Motor Unit Recruitment Threshold
Changes in motor unit recruitment threshold. As assessed by determining the amount of force (percentage of maximum volitional force output) needed to recruit an individual motor unit.
Measured: Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Jun 2021
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Thompson, PT, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891393
- Sponsor's protocol ID
- 26014
- Status last verified
- Apr 2022
- First submitted
- 11 May 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11929906Rosenberg 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.
PubMed 2682781Farina 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.
PubMed 23231985
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Caffeine on Human Spinal Motoneurons
- ClinicalTrials.gov ID
- NCT04891393
- Acronym / sponsor ID
- 26014
- Conditions
- Healthy
- Keywords
- Motor Neuron, Excitability, Caffeine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recently, it has been shown that human spinal motoneurons do not simply act as a binary control system. Instead, they are regulated by intrinsic properties that can elicit lingering effects on the descending motoneuron. Caffeine, one of the world's most popular over-the-counter supplements, can potentially augment these characteristics of motoneurons. Using decomposition software and non-invasive, high-density surface electromyography, it is possible to extract the characteristics of these motoneurons. This project will utilize a double-blind, inactive-placebo controlled, crossover design study to examine and quantify the effects of caffeine on motoneuron excitability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Dietary Supplement: CoffeeSingle-dose, orally ingested, instant coffee. |
| Inactive Placebo | Placebo comparator | Dietary Supplement: Decaffeinated coffeeSingle-dose, orally ingested, instant decaffeinated coffee (equal weight to intervention dose). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ● Between 18 and 70 years of age
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoffeeStarbucks brand "Via" instant coffee. (Caffeine Content: 3 mg / kg) | Dietary supplement | Caffeine |
| Decaffeinated coffeeStarbucks brand "Via" instant decaffeinated coffee. (Caffeine Content: 15 - 25 mg) | Dietary supplement | Inactive Placebo |
Primary outcome
Motoneuron excitability (Delta-f)
Time frame: Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
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).
3 secondary outcomes
Motor Unit Discharge Rate
Time frame: Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
Coherence
Time frame: Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
Motor Unit Recruitment Threshold
Time frame: Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Background: PubMed 11929906Gorassini 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.
- Background: PubMed 2682781Rosenberg 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.
- Background: PubMed 23231985Farina 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Thompson, PT, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee and Decaffeinated coffee in people with Healthy, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motoneuron excitability (Delta-f) (time frame: Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04891393, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.