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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06138015
Other study ID # BJozwiak_PhD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date July 1, 2023

Study information

Verified date November 2023
Source Poznan University of Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date July 1, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 41 Years to 61 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise and Time-Restricted Eating
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.
Exercise only
Moderate intensity circuit mixed endurance and resistance exercise programme two times per week for 55 minutes for 12 weeks only.

Locations

Country Name City State
Poland Poznan University of Physical Education Poznan Wielkopolskie

Sponsors (1)

Lead Sponsor Collaborator
Poznan University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brain-derived neurotrophic factor Level of brain-derived neurotrophic factor in ng/ml Before and after 12-week intervention
Primary Glial cell derived neurotrophic factor Level of glial cell derived neurotrophic factor in ng/ml Before and after 12-week intervention
Primary Insulin Level of insulin in µIU/ml Before and after 12-week intervention
Primary Glucose Level of glucose in mg/dl Before and after 12-week intervention
Primary LDL-cholesterol Level of cholesterol LDL in mg/dl Before and after 12-week intervention
Primary Muscle mass Bioelectrical impedance analysis for estimating body composition, in particular muscle mass in kg Before and after 12-week intervention
Primary Fat mass Bioelectrical impedance analysis for estimating body composition, in particular fat mass in kg Before and after 12-week intervention
Primary Stroop test Cognitive functions assessment with Stroop test in points. Higher scores means better outcome. Before and after 12-week intervention
Primary N-back test Cognitive functions assessment with N-back test in points. Higher scores means better outcome. Before and after 12-week intervention
Primary 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
Primary One-repetition maximum test Strength assessment with one-repetition maximum test in kg Before and after 12-week intervention
Primary 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
Primary 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
Primary 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
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