Motor ActivityEarly Phase 1MSPNCT02876770
Melatonin Supplementation and Performance
A Early Phase 1 study testing Experimental: Melatonin in people with Motor Activity, run by kais.
Trial summary
The present study aimed to evaluate the possible effect of nocturnal melatonin ingestion upon short-term performances, on the following morning. Twelve soccer players from a Tunisian squad (22.9 ±1.3 years, 1.80±0.05 m, and 72.0±8.8 kg) were volunteered to perform three testing sessions, with one test session per day. Read more about this study
- Who is it for?
- Ages 20 to 23 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- Experimental: Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Jan 2013
- Phase
- Early Phase 1
- 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 20 to 23 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participants were recruited based on the following criteria: (i) paticipants must be trained at 4-6 days per week for an average of 2 h daily and (ii) they must have at least 8 years of training experience
Who cannot join
- Subjects were excluded from the study if they present one of the following criteria : heart failure, antioxidant supplementation within 3 months before the study, lower-limb injuries
About this study
Official title: Nocturnal Melatonin Ingestion Ameliorates Short Term Maximal Performances on the Following Day
The present study aimed to evaluate the possible effect of nocturnal melatonin ingestion upon short-term performances, on the following morning. Twelve soccer players from a Tunisian squad (22.9 ±1.3 years, 1.80±0.05 m, and 72.0±8.8 kg) were volunteered to perform three testing sessions, with one test session per day. During each session, MEL (5mg) , MEL (8mg) or placebo were ingested, in a randomized order, before nocturnal sleep. The next morning (08:00h), participants performed the following psycho-cognitive and physical tests: Hooper's index, reaction time, vigilance, handgrip strength , squat jump , modified agility test , Wingate anaerobic test (peak power , mean power and fatigue index ). Rating of perceived exertion was recorded immediately after the WanT, and blood lactate measures were taken after 3min of recovery. Blood glucose was measured before and 3 min after the Wingate test.
- Conditions
- Motor Activity
- Being tested
- Experimental: Melatonin, Placebo
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: MelatoninDietary supplement
Our protocol was composed of three experimental sessions. During each testing session, participants were requested to attend the laboratory at 20:00h where they ingested a standardized light meal. Melatonin (5 mg or 8 mg) or placebo were ingested in capsule in the evening at 21:00h in a double-blind randomized design
PlaceboDietary supplement
In a double-blind randomized design, participants have taken placebo supplementation in one of the three experimental sessions
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Not described Receives: Dietary Supplement: Experimental: Melatonin |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hooper's index score
Hooper's index score was measured using a specific questionnaire
Measured: At 07:30 am in the following day of the supplementation
handgrip strength (in Kg)
handgrip strength was measured using a calibrated hand dynamometer.
Measured: At 07:30 am in the following day of the supplementation
Blood lactate (µmol/l)
Lactate level was measured using Lactate Pro instrument.
Measured: Blood lactate was measured only 3 minutes after physical testing in the following day of the supplementation
reaction time (in secondes)
Reaction time was measured using an electronic timing device.
Measured: At 07:30 am in the following day of the supplementation
vigilance score
Vigilance score was measured using a specific questionnaire
Measured: At 07:30 am in the following day of the supplementation
squat jump (in centimeters)
Squat jump was assessed using a infrared jump system
Measured: At 07:30 am in the following day of the supplementation
agility (in secondes)
Agility was assessed using an electronic timing system.
Measured: At 07:30 am in the following day of the supplementation
anaerobic capacity (In watts)
Anaerobic capacity was assessed using a calibrated friction-loaded cycle ergometer
Measured: At 07:30 am in the following day of the supplementation
glucose level (µmol/l)
Glucose level was assessed using a glucometer
Measured: At 07:30 am in the following day of the supplementation (rest condition) and 3 minutes after physical testing in each experimental session
Rating of perceived exertion score
Rating of perceived exertion score was measured using a specific questionnaire
Measured: Rating of perceived exertion score was measured 3 minutes after physical testing in the following day of the supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startDec 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- kais
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, kais, University of Sfax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876770
- Sponsor's protocol ID
- CNMSS1
- Acronym
- MSP
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nocturnal Melatonin Ingestion Ameliorates Short Term Maximal Performances on the Following Day
- ClinicalTrials.gov ID
- NCT02876770
- Acronym / sponsor ID
- MSP / CNMSS1
- Conditions
- Motor Activity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- kaisUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 Aug 2016 (estimated)
- 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.
The present study aimed to evaluate the possible effect of nocturnal melatonin ingestion upon short-term performances, on the following morning. Twelve soccer players from a Tunisian squad (22.9 ±1.3 years, 1.80±0.05 m, and 72.0±8.8 kg) were volunteered to perform three testing sessions, with one test session per day. During each session, MEL (5mg) , MEL (8mg) or placebo were ingested, in a randomized order, before nocturnal sleep. The next morning (08:00h), participants performed the following psycho-cognitive and physical tests: Hooper's index, reaction time, vigilance, handgrip strength , squat jump , modified agility test , Wingate anaerobic test (peak power , mean power and fatigue index ). Rating of perceived exertion was recorded immediately after the WanT, and blood lactate measures were taken after 3min of recovery. Blood glucose was measured before and 3 min after the Wingate test.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Dietary Supplement: Experimental: Melatonin |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 23 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The participants were recruited based on the following criteria: (i) paticipants must be trained at 4-6 days per week for an average of 2 h daily and (ii) they must have at least 8 years of training experience
Key exclusion criteria (1 listed)
- Subjects were excluded from the study if they present one of the following criteria : heart failure, antioxidant supplementation within 3 months before the study, lower-limb injuries
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 |
|---|---|---|
| Experimental: MelatoninOur protocol was composed of three experimental sessions. During each testing session, participants were requested to attend the laboratory at 20:00h where they ingested a standardized light meal. Melatonin (5 mg or 8 mg) or placebo were ingested in capsule in the evening at 21:00h in a double-blind randomized design | Dietary supplement | Melatonin |
| PlaceboIn a double-blind randomized design, participants have taken placebo supplementation in one of the three experimental sessions | Dietary supplement | Placebo |
Primary outcome
Hooper's index score
Time frame: At 07:30 am in the following day of the supplementation
Hooper's index score was measured using a specific questionnaire
handgrip strength (in Kg)
Time frame: At 07:30 am in the following day of the supplementation
handgrip strength was measured using a calibrated hand dynamometer.
Blood lactate (µmol/l)
Time frame: Blood lactate was measured only 3 minutes after physical testing in the following day of the supplementation
Lactate level was measured using Lactate Pro instrument.
reaction time (in secondes)
Time frame: At 07:30 am in the following day of the supplementation
Reaction time was measured using an electronic timing device.
vigilance score
Time frame: At 07:30 am in the following day of the supplementation
Vigilance score was measured using a specific questionnaire
squat jump (in centimeters)
Time frame: At 07:30 am in the following day of the supplementation
Squat jump was assessed using a infrared jump system
agility (in secondes)
Time frame: At 07:30 am in the following day of the supplementation
Agility was assessed using an electronic timing system.
anaerobic capacity (In watts)
Time frame: At 07:30 am in the following day of the supplementation
Anaerobic capacity was assessed using a calibrated friction-loaded cycle ergometer
glucose level (µmol/l)
Time frame: At 07:30 am in the following day of the supplementation (rest condition) and 3 minutes after physical testing in each experimental session
Glucose level was assessed using a glucometer
Rating of perceived exertion score
Time frame: Rating of perceived exertion score was measured 3 minutes after physical testing in the following day of the supplementation
Rating of perceived exertion score was measured using a specific questionnaire
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Experimental: Melatonin in people with Motor Activity, run by kais.
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 1 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: stopped early, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Hooper's index score (time frame: At 07:30 am in the following day of the supplementation). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2016.