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.: PACTR202301527879754 Date of Approval: 17/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Beneficial effects of concurrent training associated with melatonin on postmenopausal women.
Official scientific title Effect of concurrent training associated with melatonin on physical capacities, cognitives and biochimicals responses
Brief summary describing the background and objectives of the trial concurrent training has been shown to be an effective modality for improving health and mitigate age-related deteriorations in health and quality of life. Moroever, several studies have highlighted the beneficial effect of melatonin in regulating biological circadian rhythms . The objective of this study was to determine the effect of melatonin ingestion associated with concurrent training on anthropometry (weight, height, fat mass, muscle mass), postural balance, muscle strength, sleep quality and biochimicals responses on postmenopausal womens.
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 Prevention
Anticipated trial start date 01/11/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 31/01/2022
Actual Last follow-up date 31/01/2022
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 38
Recruitment status Recruiting
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 exercice 3 months The group were not involved in a physical training program or supplementation 12 Uncontrolled
Experimental Group concurrent training with melatonin ingestion 3 days/week 3 months The group performed concurrent training with melatonin ingestion 13
Experimental Group concurrent training with placebo 3 days/week 3 months the group performed concurrent training with placebo ingestion 13
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aged 45-65 years old Able to engage in physical activity Had not followed a structured training program in the previous 6 months and had been weight stable for 3 months prior to the study Lower limb orthopedic surgery Medications that may affect posture and/or gait, cognitive impairmentor falling from the previous month having cardiovascular disease Having a diagnosis of diabetes, using regular medications, smokers, Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 65 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 29/07/2020 CPP Sud
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) - cardiovascular function - psychological state (pain, anxiety, depression, fatigue) Before and after intervention
Secondary Outcome Sleep quality, cognitives respenses and postural stability Before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lady Fitness Jamal abd enaser Ksour Essef Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Tahar Sfar University Hospital Taher Sfar Mahdia 5100 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Research Laboratory molecular bases of human pathology tahar sfar of Mahdia Tahar Sfar Mahdia 5100 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Omar Hammouda Road sidi mansour Sfax Tunisia
Hassan Bouzidi Mahdia Mahdia 5100 Tunisia
Henda Chahed Mahdia Mahdia 5100 Tunisia
Anis Kammoun Sfax Sfax 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 Hassan Bouzidi Bouzidihassan@yahoo.fr +21698914204 Mahdia
City Postal code Country Position/Affiliation
Mahdia Tunisia Biochimical Laboratory AHU Tahar Sfar Mahdia
Role Name Email Phone Street address
Scientific Enquiries Henda Chahed hendchahed05@gmail.com +21697590643 Mahdia
City Postal code Country Position/Affiliation
Mahdia Tunisia Biochimical Lboratory AHU Tahar Sfar Mahdia
Role Name Email Phone Street address
Scientific Enquiries Anis Kamoun aniskamoun02@yahoo.fr +21697358768 Sfax
City Postal code Country Position/Affiliation
Sfax Tunisia Biochimical laboratory of Habib Bourgiba hospital
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