Effect of Time-restricted Eating on Cognitive Function and Other Biopsychosocial Factors in Menopausal Women Undertaking a 12-week Exercise Programme
- Conditions
- MenopauseCognitive Deficits, Mild
- Interventions
- Behavioral: Exercise and Time-Restricted EatingBehavioral: Exercise only
- Registration Number
- NCT06138015
- Lead Sponsor
- Poznan University of Physical Education
- Brief Summary
The goal of this quasi-experimental study is to test effect of time-restricted eating on cognitive function and other biopsychosocial factors in menopausal women undertaking a 12-week exercise programme. The main questions to answer are:
1. What is effect of time-restricted eating on cognitive function in menopausal women undertaking a 12-week exercise programme?
2. What is effect of time-restricted eating on menopausal symptoms in menopausal women undertaking a 12-weeks exercise programme?
3. What is effect of time-restricted eating on metabolic health parameters in menopausal women undertaking a 12-weeks exercise programme?
Participants of both groups will have moderate intensity circuit mixed endurance and resistance exercise programme two times per week for 55 minutes for 12 weeks. Participants of one of two groups will not only exercise but also have a time-restricted eating following 16:8 protocol for 12 weeks.
Participants will have pre-tests and post-tests:
* blood samples collection (to measure level of brain-derived neurotrophic factor, glial cell derived neurotrophic factor, insulin, glucose, lipid profile),
* body composition analysis,
* Stroop test and N-back test,
* electroencephalography using Emotiv Epic X devices,
* One-repetition maximum test, Ruffier test,
* Questionnaire assessment (using Menopause Rating Scale and The Menopause-Specific Quality of Life Questionnaire).
Researchers will compare two groups - exercise group and combination group which will do both time-restricted eating and exercise to see if there is a modulating effect of time-restricted eating in participants undertaking exercise.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
- perimenopause, menopause or post-menopause
- lightly physically active or physically inactive
- using hormone replacement therapy or hormonal contraception
- having significant contraindications to physical exercise or time-restricted eating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise and Time-Restricted Eating Exercise and Time-Restricted Eating - Exercise only Exercise only -
- Primary Outcome Measures
Name Time Method LDL-cholesterol Before and after 12-week intervention Level of cholesterol LDL in mg/dl
N-back test Before and after 12-week intervention Cognitive functions assessment with N-back test in points. Higher scores means better outcome.
Glucose Before and after 12-week intervention Level of glucose in mg/dl
Muscle mass Before and after 12-week intervention Bioelectrical impedance analysis for estimating body composition, in particular muscle mass in kg
Brain-derived neurotrophic factor Before and after 12-week intervention Level of brain-derived neurotrophic factor in ng/ml
One-repetition maximum test Before and after 12-week intervention Strength assessment with one-repetition maximum test in kg
Menopause Rating Scale Before and after 12-week intervention Menopausal symptoms assessment with Menopause Rating Scale in points. Minimum value is 0 and maximum value is 44. Higher score means worse outcome.
Glial cell derived neurotrophic factor Before and after 12-week intervention Level of glial cell derived neurotrophic factor in ng/ml
Insulin Before and after 12-week intervention Level of insulin in μIU/ml
Fat mass Before and after 12-week intervention Bioelectrical impedance analysis for estimating body composition, in particular fat mass in kg
Ruffier test Before and after 12-week intervention Cardiorespiratory fitness assessment with Ruffier test in points. Minimum value is 0, maximum value is 10. Higher score means worse outcome.
Stroop test Before and after 12-week intervention Cognitive functions assessment with Stroop test in points. Higher scores means better outcome.
The Menopause-Specific Quality of Life Questionnaire Before and after 12-week intervention Menopausal symptoms assessment with The Menopause-Specific Quality of Life Questionnaire in points. Minimum value is 0 and maximum value is 174. Higher score means worse outcome.
Electroencephalography Before and after 12-week intervention Measurement of brain waves (alpha, beta, gamma, theta) to assess electrical activity of the brain using Emotiv Epoc X device
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Poznan University of Physical Education
🇵🇱Poznań, Wielkopolskie, Poland