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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202301473691345
Enrollment
80
Registered
2023-01-26
Start date
2023-02-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine

Interventions

Training and Early Timed restricted eating
Training and late timed restricted eating
Late Timed restricted eating
Evaluation without physical training and TRE

Sponsors

Research laboratory LINP2
Lead Sponsor
Biochemistry and Toxicology laboratory
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: *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

Exclusion criteria

Exclusion criteria: * 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.

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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).

Countries

Tunisia

Contacts

Public Contactranya;Samar amer;Miladi

The Research Unit of ISSEPS sfax; The Research Unit of Isseps Sfax

ranyaamer@gmail.com;miledisamar.7@gmail.com+21629541709;+21655770530

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026