Melatonin Supplementation and Performance

NCT02876770 | Terminated Early Phase 1

• 1 other identifier: CNMSS1
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Motor Activity

Outcome Measures

Primary Outcomes (10)

• 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

• handgrip strength (in Kg)

  handgrip strength was measured using a calibrated hand dynamometer.

  At 07:30 am in the following day of the supplementation

• 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

• reaction time (in secondes)

  Reaction time was measured using an electronic timing device.

  At 07:30 am in the following day of the supplementation

• vigilance score

  Vigilance score was measured using a specific questionnaire

  At 07:30 am in the following day of the supplementation

• squat jump (in centimeters)

  Squat jump was assessed using a infrared jump system

  At 07:30 am in the following day of the supplementation

• agility (in secondes)

  Agility was assessed using an electronic timing system.

  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

  At 07:30 am in the following day of the supplementation

• 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

• 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

Study Arms (2)

Melatonin

EXPERIMENTAL

Dietary Supplement: Experimental: Melatonin

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Experimental: Melatonin DIETARY_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

Melatonin

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 20 Years - 23 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• kais: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 24, 2016
• Study Start: December 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 24, 2016

Record last verified: 2016-08