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

Sponsor
Poznan University of Physical Education (Other)
Overall Status
Completed
CT.gov ID
NCT06138015
Collaborator
(none)
80
1
2
23
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise and Time-Restricted Eating
  • Behavioral: Exercise only
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of Time-restricted Eating on Cognitive Function and Other Biopsychosocial Factors in Menopausal Women Undertaking a 12-week Exercise Programme
Actual Study Start Date :
Aug 1, 2021
Actual Primary Completion Date :
Jan 31, 2023
Actual Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise and Time-Restricted Eating

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.

Active Comparator: Exercise only

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

Outcome Measures

Primary Outcome Measures

  1. Brain-derived neurotrophic factor [Before and after 12-week intervention]

    Level of brain-derived neurotrophic factor in ng/ml

  2. Glial cell derived neurotrophic factor [Before and after 12-week intervention]

    Level of glial cell derived neurotrophic factor in ng/ml

  3. Insulin [Before and after 12-week intervention]

    Level of insulin in μIU/ml

  4. Glucose [Before and after 12-week intervention]

    Level of glucose in mg/dl

  5. LDL-cholesterol [Before and after 12-week intervention]

    Level of cholesterol LDL in mg/dl

  6. Muscle mass [Before and after 12-week intervention]

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

  7. Fat mass [Before and after 12-week intervention]

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

  8. Stroop test [Before and after 12-week intervention]

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

  9. N-back test [Before and after 12-week intervention]

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

  10. Electroencephalography [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 [Before and after 12-week intervention]

    Strength assessment with one-repetition maximum test in kg

  12. Ruffier test [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
41 Years to 61 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Poznan University of Physical Education Poznań Wielkopolskie Poland 61-871

Sponsors and Collaborators

  • Poznan University of Physical Education

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Poznan University of Physical Education
ClinicalTrials.gov Identifier:
NCT06138015
Other Study ID Numbers:
  • BJozwiak_PhD
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023