Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202006677216503 Date of Registration: 19/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Potential therapeutic effect induced by melatonin supplementation and combined physical activity on postural stability and biological responses in obese patients
Official scientific title Acute melatonin ingestion reduced muscle damage, inflammation and oxidative stress after an exhaustive exercise in obese patients.
Brief summary describing the background and objectives of the trial It is well documented that intense physical exercise leads to inflammation, oxidative stress and muscle damage especially in obese subjects who are already predisposed to these risks. Melatonin (MLT) is considered an endogenous antioxidant which may have beneficial effects against inflammation, oxidative stress and tissue repair after a workout. The objective of this study was to examine for the first time the effect of MLT on inflammatory parameters, oxidative stress and muscle damage in obese subjects after an exhaustive exercise in obese patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 05/03/2018
Actual trial start date 12/03/2018
Anticipated date of last follow up 07/05/2018
Actual Last follow-up date 14/05/2018
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants) 23
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group melatonin session 3 mg of melatonin (Jamieson Laboratories, Toronto, Canada) 1 time 23 obese were randomized to participate in one session (HIIE + Placebo) and one session (HIIE + Melatonin) melatonin session: subject received 3 mg melatonin, 40 min prior to exercise The high-intensity interval exercise (HIIE) protocol includes a warm up and recovery period (empty pedaling) of 3 min each, and 8 intervals of 1 min (90% of MAP) alternated with 2 min of recovery (45% of MAP). 23
Control Group Placebo session 3 mg of placebo (Galpharma Laboratories, Sfax, Tunisia) 1 time 23 obese were randomized to participate in one session (HIIE + Placebo) and one session (HIIE + Melatonin) Placebo session: subject received 3 mg placebo, 40 min prior to exercise The high-intensity interval exercise (HIIE) protocol includes a warm up and recovery period (empty pedaling) of 3 min each, and 8 intervals of 1 min (90% of MAP) alternated with 2 min of recovery (45% of MAP). 23 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age 20-50 years - BMI> 30 kg / m2 - Circumference of height> 94 cm (man) - Circumference of the waist> 80 cm (woman) - No use of medication - No regular exercise for at least 6 months - Against indication to the effort - Antecedent injury - Cardiorespiratory disease - Diabetes type 2 - Smoker Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/03/2018 The south institutional human research ethics committee
Ethics Committee Address
Street address City Postal code Country
Road Manzel Cheker Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - inflammation - oxidative stress - muscle damage - cardiovascular function - aerobic capacity - psychological state (anxiety, depression, fatigue) - complete blood count Before and after exercise
Secondary Outcome - body mass index - temperature - Heart rate - Systolic and diastolic arterial pressure - lipid profile Before and after exercise
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of General Surgery Habib Bourguiba University Hospital of Sfax Road Ain km 1.5, SFAX El Ferdaouss street Sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Habib Bourguiba University Hospital El Ferdaouss street Sfax 3029 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Research Laboratory molecular bases of human pathology LR19ES13 Faculty of medicine of Sfax Majida BOULILA street, 3029 Sfax, Tunisie Sfax 3029 Tunisia University
Secondary Sponsor Department of physical medicine and functional rehabilitation Habib Bourguiba University Hospital Road El Ain km 1,5 El Ferdaouss street Sfax 3029 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Omar Hammouda Road sidi mansour Sfax Tunisia
Mouna Turki Road Al Afran Sfax Tunisia
Sameh Ghroubi Road Airport Sfax Tunisia
Habib Elleuch Road Afran Sfax Tunisia
Imen Ben Dhia Salah eddine ayoubi street Monastir Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omar Hammouda Omar_hammouda86@yahoo.fr +21652785747 Road sidi mansour
City Postal code Country Position/Affiliation
Sfax Tunisia Research Laboratory molecular bases of human pathology LR19ES13 Faculty of medicine of Sfax Sfax University Tunisia
Role Name Email Phone Street address
Public Enquiries Mouna Turki mouna.turki@gmail.com +21698338230 Road el Ain
City Postal code Country Position/Affiliation
Sfax Tunisia Research Laboratory molecular bases of human pathology LR19ES13 Faculty of medicine of Sfax Sfax University Tunisia
Role Name Email Phone Street address
Scientific Enquiries Sameh Ghroubi sghroubi@yahoo.fr +21698289209 Road Airport
City Postal code Country Position/Affiliation
Sfax Tunisia The Research Unit of the assessment of musculoskeletal disorders UR12ES18 University of Sfax Tunisia.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Inflammatory responses, muscle damage and biomarkers of oxidative stress have been assessed before and after HIIE. MLT ingestion attenuated the increase of inflammation in Leucocytes (-6.63%; p<0.01), Neutrophils (-8.14%; p<0.01), and C-reactive protein (-9.1%; p<0.001)), hepatic and muscle damage in ASAT (-3.52%; p<0.001), ALAT (-3.47%; p<0.001) and Creatine kinase (-3.94%; p<0.05) and the lipid and protein peroxidation (malondialdehyde (-11.01%; p<0.05), AOPP (-16.86%; p<0.001)). Additionally, the enzymatic antioxidant biomarkers were enhanced (Thiol (+23.81%; p<0.01), Catalase (+20.17%; p<0.01)) in the MLT session compared to the placebo session after HIIE. 08/06/2020 08/06/2020
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