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.: PACTR202310697767824 Date of Approval: 25/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact pf physical activity associated with time restricted eating on biochemical parameters, cardiac parameters, body composition, physical performance in obese women
Official scientific title Impact of walking program at two different time associated with time restricted eating diet on biochemical parameters, cardiac parameters, body composition, physical performance in obese women
Brief summary describing the background and objectives of the trial Time Restricted Eating (TRE) is a strategy that alternate between daily cycle of eating and fasting to support robust circadian rhythms. Some recent studies have shown that TRE alone could be not sufficient to improve metabolic status in obese population. Walking Practice (WP) was used as strategy to decrease body weight and cardiometabolic risk factors. The aim of this study was to investigate the effect of 12 weeks of TRE in two different period diurnal and nocturnal combined with daily WP in two periods on biochemical parameters, cardiac parameters, body composition, physical performance in women living with obesity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TWO
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 01/02/2023
Actual trial start date 01/02/2023
Anticipated date of last follow up 30/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 28
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
CPP SUD
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 Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Time restricted eating and walking program TREWP 8h Time restricted eating : 16h feeding windows (16h/ 8h ) Physical Activity :walking practice 12 weeks Participants in the Time restricted eating - Walking practice group were asked to perform a daily aerobic exercise with pedometer ( 10 000 steps per day ) in fasted state, for 12 weeks combinate with time restricted eating (8 hours of eating /16 hours of fasting) . 1800 kcal /day divided into 3 meals In the fasted state, only calorie-free drinks were allowed during 8 weeks. During the last 4 weeks of the study, participants were asked to fast between 3 a.m. to 7 p.m. instead of 10 a.m. to 6 p.m. and the hours of fed and fast cycle were kept the same (8h and 16h, respectively), since Ramadan coincided with the last month of the study. No food or drinks were allowed during the fasting period. 14
Control Group Time restricted eating group TRE 16 hours fasting 8 hours eating 12 weeks All participants were instructed to limit their food consumption to 8 hours and to fast for the remaining 16 hours each day during 12 weeks. The eating period was from 10 a.m. to 6 p.m. with 1800 kcal /day divided into 3 meals: During the last 4 weeks of the study, participants were asked to fast between 3 a.m. to 7 p.m. instead of 10 a.m. to 6 p.m. and the hours of fed and fast cycle were kept the same , since Ramadan coincided with the last month of the study. They consumed the same daily energy intake divided into two meals: 14 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age >18 years old Body mass index (BMI) >25 kg / m2 Sedentary (<4000 step/day) Accept the fasting modalities and participation in a physical activity program Be currently engaged in any type of practice supervised Severe cardiomyopathy Lung disease Severe neuropathy Cancer Uncontrolled hypertension or diabetes mellitus Liver or kidney disease Chronic corticosteroid use Severe mental illness Orthopedic problems Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 23 Year(s) 55 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 29/09/2023 comite de protection des personnes sud
Ethics Committee Address
Street address City Postal code Country
Avenue Majida BOULILA sfax 3029 Sfax Tunisia
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 29/09/2023 personal protection committee SUD
Ethics Committee Address
Street address City Postal code Country
Avenue Majida BOULILLA sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- Body composition (weight, Body Fat Mass, Lean mass, Bone Mass, Muscle mass and Body Water) will be measured with impedancemetre . 2- Change in Physical parameters : static and dynamic balance measurements will be performed throw Y balance test with both legs (write and left.) Aerobic capacity will be measured using 6 minutes walking test and spirometry. Pulsed" oxygen saturation using Pulse oximeter - SpO2 saturometer. 3- Change in biochemical parameters: change in lipid profile(i.e. Total Cholesterol (TC), High-density lipoprotein (HDL), Lowdensity lipoprotein (LDL) and Triglycerides (TG)) will be measured enzymatically. Change in hepatic profile : dosage of transaminases, alkaline phosphatase, gamma glutamyl transpeptidase and bilirubin. Change in thyroidien profile: FT4 and TSH CRP will be measured with Latex particle immunoturbidimetric test. Change in hormones:Cortisol and Insulin concentrations Change in Glucose metabolism included fasting glycemia, and HOMA-IR levels 1 week before and after intervention
Secondary Outcome Change in eating behavior parameters will be measured using differents Questionnaires 2- change in sleep quality will be evaluated using Sleep Diary * Epworth sleepiness scal. 3- Change in Quality of life will be evaluated by The Short Form Health Survey (SF12) which includes 12 items (physical activity, life and relationships with others, physical pain, perceived health, vitality, limitations due to mental state, limitations due to physical condition and mental health) 6-Physiological response: change in Cardiac variability, resting heart rate will be assessed using (Polar V 800). 1 weeks before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
the endocrinology department of hospital Hedi Chaker hospital sfax Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Higher Institute of Sport and Physical Education of Sfax Airport Road, Km 3 sfax 3000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Biochimy University Hospital Hbib borguiba road manzel chaker sfax 3000 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Hammouda Omar 200 Republic Avenue nanterre cedex 92000 France
Driss Tarak 200 Republic avenue Nanterre Cedex 92000 France
Mouna Turki sfax sfax 3000 Tunisia
Faten Haj Kacem sfax sfax 3000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bardiaa Yasmine yasminebardiaa@gmail.com +21624601819 Airport Road, Km 3
City Postal code Country Position/Affiliation
sfax 3000 Tunisia High Institute of Sport and Physical Education
Role Name Email Phone Street address
Public Enquiries Hammouda Omar omar.hammouda@parisnanterre.fr 0782931995 sfax
City Postal code Country Position/Affiliation
200 Republic Avenue 920000 Tunisia High Institute of Sport and Physical Education of Sfax University of Sfax
Role Name Email Phone Street address
Scientific Enquiries Ben Dhia Imen b.dimene@yahoo.com +21626594592 ksar hlell
City Postal code Country Position/Affiliation
moknine 3000 Tunisia molecular basis of human pathology
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 controlle
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