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.

Study Overview

• Status: Completed
• Conditions: Menopause; Cognitive Deficits, Mild
• Intervention / Treatment: Behavioral: Exercise and Time-Restricted Eating; Behavioral: Exercise only

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Wielkopolskie
    • Poznań, Wielkopolskie, Poland, 61-871
      • Poznan University of Physical Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Poznan University of Physical Education

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognitive Dysfunction; Cognition Disorders
• Other Study ID Numbers: BJozwiak_PhD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No