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.: PACTR202306614083752 Date of Approval: 15/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of melatonin administration and physical exercise during Ramadan diurnal intermittent Fasting on overweight/obesity management
Official scientific title Concomittant effects of melatonin supplementation combined with concurrent training during Ramadan diurnal intermittent fasting on sleep quality, quality of life, postural balance and biological responses in Women With Overweight/Obesity
Brief summary describing the background and objectives of the trial Several strategies including physical activity and intermittent fasting (IF) were prescribed in the management of obesity and its associated complications. Ramadan diurnal intermittent fasting is a distinctive model of intermittent fasting; however, it is associated with decreased melatonin levels, disturbances in nocturnal sleep time, physical activity and energy intake. Exogenous melatonin (MLT) administration has been shown to improve circadian rhythm misalignment, postural balance and quality of life and to mitigate cholesterol metabolism, inflammatory markers and hyperglycemia as well as to promote sleep and improve its quality. This study aimed to examine to evaluate the safety and the efficiency of exogenous MLT administration combined with a concurrent training program performed throughout Ramadan diurnal intermittent fasting on body composition, biomarkers of metabolic heath and sleep quality, quality of life and postural balance in overweight/ obese sedentary women.
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 22/04/2020
Actual trial start date 23/04/2020
Anticipated date of last follow up 25/04/2020
Actual Last follow-up date 25/04/2020
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants) 32
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group no exercise 4 weeks Participants in this group performed Ramadan diurnal intermittent fasting Ramadan without physical training program 9 Uncontrolled
Experimental Group Melatonin plus concurrent training Daily intake of 3 mg of melatonin and 3 sessions of concurrent training/week 4 weeks Participants ingested 3 mg/day of melatonin one hour before bedtime and performed Concurrent training (moderate-intensity interval training combined with resistance training) for 3 sessions/week 12
Experimental Group Placebo plus concurrent training Placebo one hour before bedtime/ day and concurrent training 3 sessions/week 4 weeks Participants ingested placebo one hour before bedtime/ day and performed concurrent training (moderate-intensity interval training combined with resistance training) for 3 sessions/week 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: 18-45 years old Sedentarity Body mass index≥ 25 kg/m² or body fat≥ 30% of the total body weight Regular and normal length menstrual cycles Smoking Musculoskeletal, metabolic, cardiovascular and cardiopulmonary disorders Engagement in dietary or physical activity program for the las six months Use of medications that could interact with melatonin or affecting body weight Use of hormonal contraceptives Pregnancy and breastfeeding Adult: 19 Year-44 Year 21 Year(s) 44 Year(s) Female
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 25/05/2019 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 Body composition, Biochemical reponses, immune responses, cardiovascular function - functional capacity - sleep quality, postural balance and quality of life Before and after intervention
Secondary Outcome Heart rate variability Before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of endocrinology 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
Research Laboratory molecular bases of human pathology LR19ES13 Faculty of medicine of Sfax Majida BOULILA street, 3029 Sfax, Tunisie 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 Hospital
COLLABORATORS
Name Street address City Postal code Country
Omar Hammouda Road sidi mansour Sfax Tunisia
Mouna Turki Road Al Afran Sfax Tunisia
Houssem Marzougui Ibn khaldoun street Sidi Bouzid Tunisia
Rami Maaloul Road Al Afran Sfax Tunisia
Faten Hadj Kacem Road Airport Sfax Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Imen Ben Dhia b.dimene@yahoo.com +21626594592 Salah Eddine Alayoubi Street
City Postal code Country Position/Affiliation
Monastir Tunisia Research Laboratory of Evaluation and Management of Musculoskeletal System Pathologies LR20ES09 University of Sfax 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 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
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years after article publication Researchers who provide a methodologically sound proposal. They have to send their proposals to b.dimene@yahoo.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 09/06/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 13/06/2023 Result - 13/06/2023 Result - 13/06/2023 Result - 13/06/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information