- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02876770
Melatonin Supplementation and Performance (MSP)
August 18, 2016 updated by: kais
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Early Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 23 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
In a double-blind randomized design, participants have taken placebo supplementation in one of the three experimental sessions
|
Experimental: Melatonin
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At 07:30 am in the following day of the supplementation
|
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.
|
At 07:30 am in the following day of the supplementation
|
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.
|
Blood lactate was measured only 3 minutes after physical testing in the following day of the supplementation
|
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.
|
At 07:30 am in the following day of the supplementation
|
vigilance score
Time Frame: At 07:30 am in the following day of the supplementation
|
Vigilance score was measured using a specific questionnaire
|
At 07:30 am in the following day of the supplementation
|
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
|
At 07:30 am in the following day of the supplementation
|
agility (in secondes)
Time Frame: At 07:30 am in the following day of the supplementation
|
Agility was assessed using an electronic timing system.
|
At 07:30 am in the following day of the supplementation
|
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
|
At 07:30 am in the following day of the supplementation
|
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
|
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
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
|
Rating of perceived exertion score was measured 3 minutes after physical testing in the following day of the supplementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
August 2, 2016
First Submitted That Met QC Criteria
August 18, 2016
First Posted (Estimate)
August 24, 2016
Study Record Updates
Last Update Posted (Estimate)
August 24, 2016
Last Update Submitted That Met QC Criteria
August 18, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNMSS1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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