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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06138015
• Other study ID #: BJozwiak_PhD
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Menopause

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