Skip to main content
OpenTrials
Completed

NCT Number: NCT06138015

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Menopause Cognition Disorders Cognitive Deficits, Mild Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Neurocognitive Disorders

Age range

41 year–61 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Physical Education

Poznan, Greater Poland Voivodeship, 61-871, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise and Time-Restricted Eating

Behavioral

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

Behavioral

Moderate intensity circuit mixed endurance and resistance exercise programme two times per week for 55 minutes for 12 weeks only.

Primary outcomes

  1. Brain-derived neurotrophic factor

    Time frame: Before and after 12-week intervention

    Level of brain-derived neurotrophic factor in ng/ml

  2. Glial cell derived neurotrophic factor

    Time frame: Before and after 12-week intervention

    Level of glial cell derived neurotrophic factor in ng/ml

  3. Insulin

    Time frame: Before and after 12-week intervention

    Level of insulin in μIU/ml

  4. Glucose

    Time frame: Before and after 12-week intervention

    Level of glucose in mg/dl

  5. LDL-cholesterol

    Time frame: Before and after 12-week intervention

    Level of cholesterol LDL in mg/dl

  6. Muscle mass

    Time frame: Before and after 12-week intervention

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

  7. Fat mass

    Time frame: Before and after 12-week intervention

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

  8. Stroop test

    Time frame: Before and after 12-week intervention

    Cognitive functions assessment with Stroop test in points. Higher scores means better outcome.

  9. 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.

  10. 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

  11. One-repetition maximum test

    Time frame: Before and after 12-week intervention

    Strength assessment with one-repetition maximum test in kg

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.