- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02876770
Melatonin Supplementation and Performance (MSP)
18. August 2016 aktualisiert von: 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.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
12
Phase
- Frühphase 1
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre bis 23 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Männlich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: Placebo
|
In a double-blind randomized design, participants have taken placebo supplementation in one of the three experimental sessions
|
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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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Hooper's index score
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
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anaerobic capacity (In watts)
Zeitfenster: At 07:30 am in the following day of the supplementation
|
Anaerobic capacity was assessed using a calibrated friction-loaded cycle ergometer
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At 07:30 am in the following day of the supplementation
|
|
glucose level (µmol/l)
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Dezember 2012
Primärer Abschluss (Tatsächlich)
1. Januar 2013
Studienabschluss (Tatsächlich)
1. Januar 2013
Studienanmeldedaten
Zuerst eingereicht
2. August 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. August 2016
Zuerst gepostet (Schätzen)
24. August 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
24. August 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. August 2016
Zuletzt verifiziert
1. August 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CNMSS1
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