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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02876770
Other study ID # CNMSS1
Secondary ID
Status Terminated
Phase Phase 0
First received August 2, 2016
Last updated August 18, 2016
Start date December 2012
Est. completion date January 2013

Study information

Verified date August 2016
Source University of Sfax
Contact n/a
Is FDA regulated No
Health authority Tunisia: Ministry of health
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 23 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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
Placebo
In a double-blind randomized design, participants have taken placebo supplementation in one of the three experimental sessions

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
kais

Outcome

Type Measure Description Time frame Safety issue
Primary Hooper's index score Hooper's index score was measured using a specific questionnaire At 07:30 am in the following day of the supplementation No
Primary handgrip strength (in Kg) handgrip strength was measured using a calibrated hand dynamometer. At 07:30 am in the following day of the supplementation No
Primary Blood lactate (µmol/l) 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 No
Primary reaction time (in secondes) Reaction time was measured using an electronic timing device. At 07:30 am in the following day of the supplementation No
Primary vigilance score Vigilance score was measured using a specific questionnaire At 07:30 am in the following day of the supplementation No
Primary squat jump (in centimeters) Squat jump was assessed using a infrared jump system At 07:30 am in the following day of the supplementation No
Primary agility (in secondes) Agility was assessed using an electronic timing system. At 07:30 am in the following day of the supplementation No
Primary anaerobic capacity (In watts) Anaerobic capacity was assessed using a calibrated friction-loaded cycle ergometer At 07:30 am in the following day of the supplementation No
Primary glucose level (µmol/l) 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 No
Primary Rating of perceived exertion score 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 No
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