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Clinical Trials/NCT06138015
NCT06138015
Completed
Not Applicable

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

Poznan University of Physical Education1 site in 1 country80 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Menopause
Sponsor
Poznan University of Physical Education
Enrollment
80
Locations
1
Primary Endpoint
LDL-cholesterol
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
July 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Poznan University of Physical Education
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

LDL-cholesterol

Time Frame: Before and after 12-week intervention

Level of cholesterol LDL in mg/dl

N-back test

Time Frame: Before and after 12-week intervention

Cognitive functions assessment with N-back test in points. Higher scores means better outcome.

Glucose

Time Frame: Before and after 12-week intervention

Level of glucose in mg/dl

Muscle mass

Time Frame: Before and after 12-week intervention

Bioelectrical impedance analysis for estimating body composition, in particular muscle mass in kg

Brain-derived neurotrophic factor

Time Frame: Before and after 12-week intervention

Level of brain-derived neurotrophic factor in ng/ml

Glial cell derived neurotrophic factor

Time Frame: Before and after 12-week intervention

Level of glial cell derived neurotrophic factor in ng/ml

Insulin

Time Frame: Before and after 12-week intervention

Level of insulin in μIU/ml

Fat mass

Time Frame: Before and after 12-week intervention

Bioelectrical impedance analysis for estimating body composition, in particular fat mass in kg

One-repetition maximum test

Time Frame: Before and after 12-week intervention

Strength assessment with one-repetition maximum test in kg

Menopause Rating Scale

Time Frame: 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.

Ruffier test

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Study Sites (1)

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