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.: PACTR202301473691345 Date of Approval: 26/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of self-regulated physical activity and time restriction of food intake at different times of the day on biological, psycho-cognitive and physiological adaptations in overweight and obese women.
Official scientific title Effect of self-regulated physical activity (strength and endurance) and time restriction of food intake (16/8) at different times of the day on biological, psycho-cognitive and physiological adaptations in overweight and obese women.
Brief summary describing the background and objectives of the trial Obesity is a chronic disease that affects the quality of life physiologically, economically and psychologically, regardless of the cultural, financial or ethnic background. Globally, the WHO estimates the prevalence of overweight and obesity respectively at 39% and 13% in adults (WHO, 2016). This high prevalence seems to depend on several factors: change in the lifestyle of individuals, junk food, sedentary lifestyle, endocrine disruptors, light exposure at night and reduction in the duration and quality of sleep. Various types of calorie restriction, intermittent fasting and alternate day fasting, are useful in combating obesity since not only quantity but also time of food intake can affect weight loss and improve cardiometabolic health. Timed restricted eating (TRE) may improve body compositions and cardiometabolic health in obese subjects (Patterson and al., 2015 Morales-Suarez-Varela and al., 2021).Previous studies showed contradictory results. Overall, some of these showed more beneficial effects for shorter feeding windows (Manoogian et al., 2022) and others have failed to show the effectiveness of TRE on weight loss and metabolic pattern (Lowe and al.,2020 ; Liu and al., 2022). However, nutritional strategies do not seem to be sufficient to have a significant reduction in weight if they are not combined with the practice of appropriate physical activity. It is established that this association could induce several beneficial effects. (Haganes and al., 2022). Our study aim to investigate the effect of TRE at two differents times of the day combined with aerobic and muscle strength training on body composition, cardiometabolic health, autonomic cardiac function, physical performance and respiratory function in overweight and obese women.Finally this project aims to determine the effect of 8 h of TRE and adapted physical activity on eating behavior, quality of life and quality of sleep in overweight and obese 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 22/02/2023
Actual trial start date
Anticipated date of last follow up 22/05/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
0460 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 Training and Early Timed restricted eating 1- Early timed restricted eating : 16h feeding windows (16 pm - 8 am) and 8 h for consuming foods (8 am-16pm) 2 - Training sessions : Endurance and Resistance Training 12 weeks The protocol consisted on two blood samples, 10 subjective psycho-cognitive evaluations and 8 physiological and physical evaluations, 48 hours pre and post intervention , pre and post concurrent training (three sessions/week) for 12 weeks associated with a daily early timed restricted eating (16/8). Sleep/wake cycles will be evaluated via actimetry. The blood samples will be conducted 48 hours pre and post intervention, approximately 10 ml of venous blood will be taken from the arteriovenous fistule after supine rest in the morning at the laboratory of biochemistry.Samples will be immediately centrifuged at 300 rpm and 40 for 10 min Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. For physiological evaluation: autonomic heart function will be investigated using a heart rate monitor (v 800) For physical evaluation: static and dynamic balance measurements will be performed throw Y balance test with both legs (write and left) Aerobic capacity and respiratory volumes will be measured using 6 minutes walking test and spirometry. The abalakov jump test will be used to measure leg power. Maximum muscle strength will be determined using a maximum repetition test (1RM), women will attempt to familiarize themselves with each of the resistance machines (leg press) (weight bench with loaded bars) by performing 8-10 reps of a light load (~50% of expected 1RM), followed by (80 % of estimated 1RM). After each successful performance, the weight would increase until an unsuccessful attempt occurred. Psycho-cognitive assessment will be performed using questionnaires. 15
Experimental Group Training and late timed restricted eating 1- Late timed restricted eating : 16h feeding windows (16 pm - 8 am) and 8 h for consuming foods (8 am-16 pm) 2 - Training sessions : Endurance and Resistance Training 12 weeks The protocol consisted on two blood samples, 10 subjective psycho-cognitive evaluations and 8 physiological and physical evaluations,48 hours pre and post intervention , pre and post concurrent training (three sessions/week) for 12 weeks associated with a daily early timed restricted eating (16/8). Sleep/wake cycles will be evaluated via actimetry. The blood samples will be conducted 48 hours pre and post intervention, approximately 10 ml of venous blood will be taken from the arteriovenous fistule after supine rest in the morning at the laboratory of biochemistry.Samples will be immediately centrifuged at 300 rpm and 40 for 10 min Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. For physiological evaluation: autonomic heart function will be investigated using a heart rate monitor (v 800) For physical evaluation: static and dynamic balance measurements will be performed throw Y balance test with both legs (write and left) Aerobic capacity and respiratory volumes will be measured using 6 minutes walking test and spirometry. The abalakov jump test will be used to measure leg power. Maximum muscle strength will be determined using a maximum repetition test (1RM), women will attempt to familiarize themselves with each of the resistance machines (leg press) (weight bench with loaded bars) by performing 8-10 reps of a light load (~50% of expected 1RM), followed by (80 % of estimated 1RM). After each successful performance, the weight would increase until an unsuccessful attempt occurred. Psycho-cognitive assessment will be performed using questionnaires. 15
Experimental Group Late Timed restricted eating Late timed restricted eating : 16h feeding windows (16 pm - 8 am) and 8 h for consuming foods (8 am-16pm) 12 weeks The protocol consisted on two blood samples, 10 subjective psycho-cognitive evaluations and 8 physiological and physical evaluations, 48 hours pre and post intervention , pre and post concurrent training (three sessions/week) for 12 weeks associated with a daily early timed restricted eating (16/8). Sleep/wake cycles will be evaluated via actimetry. The blood samples will be conducted 48 hours pre and post intervention, approximately 10 ml of venous blood will be taken from the arteriovenous fistule after supine rest in the morning at the laboratory of biochemistry.Samples will be immediately centrifuged at 300 rpm and 40 for 10 min Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. For physiological evaluation: autonomic heart function will be investigated using a heart rate monitor (v 800) For physical evaluation: static and dynamic balance measurements will be performed throw Y balance test with both legs (write and left) Aerobic capacity and respiratory volumes will be measured using 6 minutes walking test and spirometry. The abalakov jump test will be used to measure leg power. Maximum muscle strength will be determined using a maximum repetition test (1RM), women will attempt to familiarize themselves with each of the resistance machines (leg press) (weight bench with loaded bars) by performing 8-10 reps of a light load (~50% of expected 1RM), followed by (80 % of estimated 1RM). After each successful performance, the weight would increase until an unsuccessful attempt occurred. Psycho-cognitive assessment will be performed using questionnaires. 15
Control Group Evaluation without physical training and TRE 1- Without feeding restriction 2 - Without training sessions 12 Weeks This group will not be subjected to any physical activity or feeding restriction throughout the period of the experimentation and will undergo only the evaluation tests.The protocol consisted on two blood samples, 10 subjective psycho-cognitive evaluations and 8 physiological and physical evaluations, 48 hours pre and post intervention , pre and post concurrent training (three sessions/week) for 12 weeks associated with a daily early timed restricted eating (16/8). Sleep/wake cycles will be evaluated via actimetry. The blood samples will be conducted 48 hours pre and post intervention, approximately 10 ml of venous blood will be taken from the arteriovenous fistule after supine rest in the morning at the laboratory of biochemistry.Samples will be immediately centrifuged at 300 rpm and 40 for 10 min Aliquots of the resulting plasma will be stored at -70°C until analyzed. All samples will be analyzed in the same assay run to eliminate inter-assay variance. For physiological evaluation: autonomic heart function will be investigated using a heart rate monitor (v 800) For physical evaluation: static and dynamic balance measurements will be performed throw Y balance test with both legs (write and left) Aerobic capacity and respiratory volumes will be measured using 6 minutes walking test and spirometry. The abalakov jump test will be used to measure leg power. Maximum muscle strength will be determined using a maximum repetition test (1RM), women will attempt to familiarize themselves with each of the resistance machines (leg press) (weight bench with loaded bars) by performing 8-10 reps of a light load (~50% of expected 1RM), followed by (80 % of estimated 1RM). After each successful performance, the weight would increase until an unsuccessful attempt occurred. Psycho-cognitive assessment will be performed using questionnaires. 16 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
*Overweight and obese patients under 60 years old *BMI >=25 kg /m² *Sedentary and able to practice physical exercise * Stable Weight for the last 6 months * Agree to eat meals during given times of the day * 6 months before the study: Taking any type of antioxidant substances, vitamins or anti-inflammatory drugs. * No hormonal treatments or sleeping pills (hypnotics and anxiolytics) two weeks before the study * Patients who have undergone a rehabilitation protocol * Smoking, alcoholism, drugs * Other chronic or autoimmune neurodegenerative comorbidities. * Diabetes, osteoporosis, other neurological, vestibular, cognitive, orthopedic, and psychiatric disorders. *Any contraindication to the practice of a physical activity (serious cardiovascular or pulmonary diseases). * Pregnant or lactating women in the last six months. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 16/12/2022 The Committee of Protection of persons in south
Ethics Committee Address
Street address City Postal code Country
Avenue Majida BOULILA 3029 Sfax, Tunisie 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 throw impedancemetr . 2- Cardio-respiraotry capacity will be measured during 6 minutes walking test with using spirometry one time: pre intervention.Systolic blood pressure and diastolic blood pressure using blood pressure monitor. 3- Change in Physical parameters : static and dynamic balance measurements will be performed throw Y balance test with both legs (write and left.) Aerobic capacity and respiratory volumes will be measured using 6 minutes walking test and spirometry. Pulsed" oxygen saturation using Pulse oximeter - SpO2 saturometer. The abalakov jump test will be used to measure leg power.Maximum muscle strength will be determined using a maximum repetition test (1RM), women will attempt to familiarize themselves with each of the resistance machines (leg press) (weight bench with loaded bars) by performing 8-10 reps of a light load (~50% of expected 1RM), followed by (80 % of estimated 1RM). After each successful performance, the weight would increase until an unsuccessful attempt occurred. 4- 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 48 hours before and after intervention
Secondary Outcome 1-Change in eating behavior parameters will be measured using differents Questionnaires ( TFEQ : Three factor eating Questionnaire, EDE-Q : Eating disorders diagnosis and EDRSQ-F : Eating disorder.) 2- change in cognitive function will be assessed using the Mini Mental State (MMSE) and Barrage numbers tests which assesses different cognitive domains: attention and concentration, executive functions, memory, language, Visuoconstructional skills, conceptual thinking, calculations and orientation, 3- Change in Psychological parameters will be measured using SEPOB questionnaire that assesses the feeling of self-efficacy specific to obesity. 4- change in sleep quality will be evaluated using Sleep Diary * Epworth sleepiness scale: include eight questions, and its total score varies between 0 and 10 and whose score equal to or more 10 corresponds to sleep disorders. * Actimetry. 5- Change in Quality of life will be evaluated by The Short Form Health Survey (SF36) which includes 36 items divided into 8 dimensions (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). 48 hours before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lady Fitness Bia street Mahdia road Mahdia 5100 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Biochimy University Hospital Fatouma Borgiba Farahad Hachad Avenue Monastir 5000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Research laboratory LINP2 200 republic avenue Nanterre 92000 France University
Secondary Sponsor Biochemistry and Toxicology laboratory Avenue Farhat Hached Monastir 5000 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
de Marco Giovanni 200 Republic Avenue Nanterre 92000 France
Driss Tarak 200 Republic avenue Nanterre Cedex 92000 France
Hammouda Omar 200 Republic Avenue Nanterre Cedex 92000 France
Naffati Fadwa Farahad Hachad Avenue Monastir 5000 Tunisia
Amer Ranya Bia street road Mahdia Mahdia 5100 Tunisia
Miladi Samar 9 Street Algeria Monastir Ksar hellal 5070 Tunisia
Miladi Sirine 9 Street Algeria Monastir ksar hellal 5070 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sarra Miladi miledi_sarra@hotmail.fr 0749556769 6 Boulevard Friedberg
City Postal code Country Position/Affiliation
Villiers Sur Marne 94350 France Research laboratory LINP2
Role Name Email Phone Street address
Scientific Enquiries Tarak Driss tarak.driss@parisnanterre.fr 0636414400 200 Republic Avenue
City Postal code Country Position/Affiliation
Nanterre Cedex 92000 France Research Laboratory LINP2
Role Name Email Phone Street address
Scientific Enquiries Omar Hammouda omar.hammouda@parisnanterre.fr 0782931995 200 Republic Avenue
City Postal code Country Position/Affiliation
Nanterre Cedex 92000 France Research Laboratory LINP2
Role Name Email Phone Street address
Public Enquiries ranya amer ranyaamer@gmail.com +21629541709 Bia street road Mahdia
City Postal code Country Position/Affiliation
mahdia 5000 Tunisia The Research Unit of ISSEPS sfax
Role Name Email Phone Street address
Public Enquiries Samar Miladi miledisamar.7@gmail.com +21655770530 9 Street Algeria
City Postal code Country Position/Affiliation
Monastir Ksar Hellal 5070 Tunisia The Research Unit of Isseps Sfax
Role Name Email Phone Street address
Public Enquiries Sirine Miladi sirinemiledi376@gmail.com +21650192500 9 Street Algeria
City Postal code Country Position/Affiliation
Monastir ksar hellal 5070 Tunisia The Research Unit of Isseps Sfax
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data will be collected during the trial, after identification Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 years key for all participant
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not yet 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