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.: PACTR202203475387226 Date of Approval: 03/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ramadan intermittent fasting and physical training in management of obesity and overweight
Official scientific title Combined effects of different exercise modalities and Ramadan intermittent fasting on body composition and biochemical, immune and metabolic responses in people with obesity
Brief summary describing the background and objectives of the trial Interval exercise has been shown to be an effective modality for improving health and an efficient alternative in time management compared to traditional continuous exercise in the management of overweight and obesity. Moroever, several studies have highlighted the importance of Ramadan fasting on health due to its convenience and benefits for improving body composition, insulin sensitivity, fat oxidation and many other biochemical, cardiovascular and metabolic adaptations in people with obesity . The first objective of this study was to examine the effect of high-intensity (HIIT) and moderate-intensity (MIIT) interval training in Ramadan intermittent fasting on body composition and metabolic ,immune and biochemical responses in people with obesity. The second objective was to assess the best time of training in Ramadan intermittent fasting.
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 24/04/2020
Actual trial start date 24/04/2020
Anticipated date of last follow up 23/05/2020
Actual Last follow-up date 23/05/2020
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants) 40
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group no exercise 4 weeks the group fasted Ramadan and were not involved in a physical training program 10 Uncontrolled
Experimental Group HIIT feeding state 4 days/week 4 weeks the group fasted Ramadan and performed a high intensity interval training after breaking the fast 10
Experimental Group MIIT feeding state 4 days/week 4 weeks the group fasted Ramadan and performed a moderate intensity interval training after breaking the fast 10
Experimental Group MIIT fasting state 4 days/week 4 weeks the group fasted Ramadan and performed a moderate intensity interval training before breaking the fast 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age 20-44 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 20 Year(s) 44 Year(s) Male
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 (inflammation, muscle damage, glucose, lipid profile, oxidative stress) - immune responses - cardiovascular function - aerobic capacity - psychological state (pain, anxiety, depression, fatigue) Before and after intervention
Secondary Outcome - sleep quality - temperature - Energy intake - Heart rate variability Before and after intervention
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 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
Imen Ben Dhia Salah eddine ayoubi street Monastir Tunisia
Houssem Marzougui ib khaldoun, sidi bouzid sidi bouzid 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
Yes IPD that will be generated from this study will be shared on request after deidentification (text, tables, figures, and appendices) Statistical Analysis Plan,Study Protocol 2 years controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information