Clinical trial NCT06138015: Effect of Time-restricted Eating on Cognitive Function and Other Biopsychosocial Factors in Menopausal Women Undertaking a 12-week Exercise Programme
Official title: Effect of Time-restricted Eating on Cognitive Function and Other Biopsychosocial Factors in Menopausal Women Undertaking a 12-week Exercise Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Cognitive Deficits, Mild
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 41
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Brain-derived neurotrophic factor
timeFrame: Before and after 12-week intervention
measure: Glial cell derived neurotrophic factor
timeFrame: Before and after 12-week intervention
measure: Insulin
timeFrame: Before and after 12-week intervention
measure: Glucose
timeFrame: Before and after 12-week intervention
measure: LDL-cholesterol
timeFrame: Before and after 12-week intervention
measure: Muscle mass
timeFrame: Before and after 12-week intervention
measure: Fat mass
timeFrame: Before and after 12-week intervention
measure: Stroop test
timeFrame: Before and after 12-week intervention
measure: N-back test
timeFrame: Before and after 12-week intervention
measure: Electroencephalography
timeFrame: Before and after 12-week intervention
measure: One-repetition maximum test
timeFrame: Before and after 12-week intervention
measure: Ruffier test
timeFrame: Before and after 12-week intervention
measure: Menopause Rating Scale
timeFrame: Before and after 12-week intervention
measure: The Menopause-Specific Quality of Life Questionnaire
timeFrame: Before and after 12-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Physical Education
state: Wielkopolskie
Study officials:
References: