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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06138015
Enrollment
80
Registered
2023-11-18
Start date
2021-08-01
Completion date
2023-07-01
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, Cognitive Deficits, Mild

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.

Interventions

BEHAVIORALExercise 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.

BEHAVIORALExercise only

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

Sponsors

Poznan University of Physical Education
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
41 Years to 61 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Brain-derived neurotrophic factorBefore and after 12-week interventionLevel of brain-derived neurotrophic factor in ng/ml
Glial cell derived neurotrophic factorBefore and after 12-week interventionLevel of glial cell derived neurotrophic factor in ng/ml
InsulinBefore and after 12-week interventionLevel of insulin in μIU/ml
GlucoseBefore and after 12-week interventionLevel of glucose in mg/dl
LDL-cholesterolBefore and after 12-week interventionLevel of cholesterol LDL in mg/dl
Muscle massBefore and after 12-week interventionBioelectrical impedance analysis for estimating body composition, in particular muscle mass in kg
Fat massBefore and after 12-week interventionBioelectrical impedance analysis for estimating body composition, in particular fat mass in kg
Stroop testBefore and after 12-week interventionCognitive functions assessment with Stroop test in points. Higher scores means better outcome.
N-back testBefore and after 12-week interventionCognitive functions assessment with N-back test in points. Higher scores means better outcome.
ElectroencephalographyBefore and after 12-week interventionMeasurement of brain waves (alpha, beta, gamma, theta) to assess electrical activity of the brain using Emotiv Epoc X device
One-repetition maximum testBefore and after 12-week interventionStrength assessment with one-repetition maximum test in kg
Ruffier testBefore and after 12-week interventionCardiorespiratory fitness assessment with Ruffier test in points. Minimum value is 0, maximum value is 10. Higher score means worse outcome.
Menopause Rating ScaleBefore and after 12-week interventionMenopausal symptoms assessment with Menopause Rating Scale in points. Minimum value is 0 and maximum value is 44. Higher score means worse outcome.
The Menopause-Specific Quality of Life QuestionnaireBefore and after 12-week interventionMenopausal 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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026