Effect of Time-restricted Eating on Cognitive Function and Other Biopsychosocial Factors in Menopausal Women Undertaking a 12-week Exercise Programme

Study Overview
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Brief Summary
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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: What is effect of time-restricted eating on cognitive function in menopausal women undertaking a 12-week exercise programme? What is effect of time-restricted eating on menopausal symptoms in menopausal women undertaking a 12-weeks exercise programme? 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.

Official Title
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Effect of Time-restricted Eating on Cognitive Function and Other Biopsychosocial Factors in Menopausal Women Undertaking a 12-week Exercise Programme

Conditions
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Menopause, Cognitive Deficits, Mild

Intervention / Treatment
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* Behavioral: Exercise and Time-Restricted Eating
* Behavioral: Exercise only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: perimenopause, menopause or post-menopause lightly physically active or physically inactive Exclusion Criteria: using hormone replacement therapy or hormonal contraception having significant contraindications to physical exercise or time-restricted eating

Ages Eligible for Study
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Minimum Age: 41 Years
Maximum Age: 61 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and Time-Restricted Eating<br> | Behavioral: Exercise and Time-Restricted Eating<br>* Moderate intensity circuit mixed endurance and resistance exercise programme two times per week for 55 minutes for 12 weeks and a time-restricted eating following 16:8 protocol for 12 weeks.<br>|
| Active Comparator: Exercise only<br> | Behavioral: Exercise only<br>* Moderate intensity circuit mixed endurance and resistance exercise programme two times per week for 55 minutes for 12 weeks only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain-derived neurotrophic factor | Level of brain-derived neurotrophic factor in ng/ml | Before and after 12-week intervention | 
| Glial cell derived neurotrophic factor | Level of glial cell derived neurotrophic factor in ng/ml | Before and after 12-week intervention | 
| Insulin | Level of insulin in μIU/ml | Before and after 12-week intervention | 
| Glucose | Level of glucose in mg/dl | Before and after 12-week intervention | 
| LDL-cholesterol | Level of cholesterol LDL in mg/dl | Before and after 12-week intervention | 
| Muscle mass | Bioelectrical impedance analysis for estimating body composition, in particular muscle mass in kg | Before and after 12-week intervention | 
| Fat mass | Bioelectrical impedance analysis for estimating body composition, in particular fat mass in kg | Before and after 12-week intervention | 
| Stroop test | Cognitive functions assessment with Stroop test in points. Higher scores means better outcome. | Before and after 12-week intervention | 
| N-back test | Cognitive functions assessment with N-back test in points. Higher scores means better outcome. | Before and after 12-week intervention | 
| Electroencephalography | Measurement of brain waves (alpha, beta, gamma, theta) to assess electrical activity of the brain using Emotiv Epoc X device | Before and after 12-week intervention | 
| One-repetition maximum test | Strength assessment with one-repetition maximum test in kg | Before and after 12-week intervention | 
| Ruffier test | Cardiorespiratory fitness assessment with Ruffier test in points. Minimum value is 0, maximum value is 10. Higher score means worse outcome. | Before and after 12-week intervention | 
| Menopause Rating Scale | Menopausal symptoms assessment with Menopause Rating Scale in points. Minimum value is 0 and maximum value is 44. Higher score means worse outcome. | Before and after 12-week intervention | 
| The Menopause-Specific Quality of Life Questionnaire | 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. | Before and after 12-week intervention |