MenopauseNCT06138015
Effect of Time-restricted Eating on Cognitive Function and Other Biopsychosocial Factors in Menopausal Women Undertaking a 12-week Exercise Programme
A study testing Exercise and Time-Restricted Eating and Exercise only in people with Menopause and Cognitive Deficits, Mild, run by Poznan University of Physical Education at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 41 to 61 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Cognitive Deficits, Mild
- What is being tested?
- Exercise and Time-Restricted Eating and Exercise only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 61 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- perimenopause, menopause or post-menopause
- lightly physically active or physically inactive
Who cannot join
- using hormone replacement therapy or hormonal contraception
- having significant contraindications to physical exercise or time-restricted eating
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Physical Education
Poznan, Greater Poland Voivodeship, 61-871
About this study
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:
- What is effect of time-restricted eating on cognitive function in menopausal women undertaking a 12-week exercise programme?
- What is effect of time-restricted eating on menopausal symptoms in menopausal women undertaking a 12-weeks exercise programme?
- What is effect of time-restricted eating on metabolic health parameters in menopausal women undertaking a 12-weeks exercise programme?
Read more
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.
- Conditions
- Menopause, Cognitive Deficits, Mild
- Being tested
- Exercise and Time-Restricted Eating, Exercise only
- Medical subject headings
- Cognition Disorders, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and Time-Restricted EatingBehavioural
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 onlyBehavioural
Moderate intensity circuit mixed endurance and resistance exercise programme two times per week for 55 minutes for 12 weeks only.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Time-Restricted Eating | Experimental | Not described Receives: Behavioral: Exercise and Time-Restricted Eating |
| Exercise only | Active comparator | Not described Receives: Behavioral: Exercise only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain-derived neurotrophic factor
Level of brain-derived neurotrophic factor in ng/ml
Measured: Before and after 12-week intervention
Glial cell derived neurotrophic factor
Level of glial cell derived neurotrophic factor in ng/ml
Measured: Before and after 12-week intervention
Insulin
Level of insulin in μIU/ml
Measured: Before and after 12-week intervention
Glucose
Level of glucose in mg/dl
Measured: Before and after 12-week intervention
LDL-cholesterol
Level of cholesterol LDL in mg/dl
Measured: Before and after 12-week intervention
Muscle mass
Bioelectrical impedance analysis for estimating body composition, in particular muscle mass in kg
Measured: Before and after 12-week intervention
Fat mass
Bioelectrical impedance analysis for estimating body composition, in particular fat mass in kg
Measured: Before and after 12-week intervention
Stroop test
Cognitive functions assessment with Stroop test in points. Higher scores means better outcome.
Measured: Before and after 12-week intervention
N-back test
Cognitive functions assessment with N-back test in points. Higher scores means better outcome.
Measured: 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
Measured: Before and after 12-week intervention
One-repetition maximum test
Strength assessment with one-repetition maximum test in kg
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Aug 2021
- Primary completion31 Jan 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138015
- Sponsor's protocol ID
- BJozwiak_PhD
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jozwiak B, Kleka P, Laudanska-Krzeminska I. Effect of exercise alone and in combination with time-restricted eating on cognitive health in menopausal women. Front Public Health. 2025 Aug 13;13:1640512. doi: 10.3389/fpubh.2025.1640512. eCollection 2025.
PubMed 40880914Jozwiak B, Domin R, Krzywicka M, Laudanska-Krzeminska I. Effect of exercise alone and in combination with time-restricted eating on cardiometabolic health in menopausal women. J Transl Med. 2024 Oct 21;22(1):957. doi: 10.1186/s12967-024-05738-y.
PubMed 39434160
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Time-restricted Eating on Cognitive Function and Other Biopsychosocial Factors in Menopausal Women Undertaking a 12-week Exercise Programme
- ClinicalTrials.gov ID
- NCT06138015
- Acronym / sponsor ID
- BJozwiak_PhD
- Conditions
- Menopause, Cognitive Deficits, Mild
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is effect of time-restricted eating on cognitive function in menopausal women undertaking a 12-week exercise programme?
- What is effect of time-restricted eating on menopausal symptoms in menopausal women undertaking a 12-weeks exercise programme?
- 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and Time-Restricted Eating | Experimental | Behavioral: Exercise and Time-Restricted Eating |
| Exercise only | Active comparator | Behavioral: Exercise only |
Who may qualify
- Ages
- 41 to 61 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- perimenopause, menopause or post-menopause
- lightly physically active or physically inactive
Key exclusion criteria (2 listed)
- using hormone replacement therapy or hormonal contraception
- having significant contraindications to physical exercise or time-restricted eating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and Time-Restricted EatingModerate 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. | Behavioural | Exercise and Time-Restricted Eating |
| Exercise onlyModerate intensity circuit mixed endurance and resistance exercise programme two times per week for 55 minutes for 12 weeks only. | Behavioural | Exercise only |
Primary outcome
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
Glucose
Time frame: Before and after 12-week intervention
Level of glucose in mg/dl
LDL-cholesterol
Time frame: Before and after 12-week intervention
Level of cholesterol LDL 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
Fat mass
Time frame: Before and after 12-week intervention
Bioelectrical impedance analysis for estimating body composition, in particular fat mass in kg
Stroop test
Time frame: Before and after 12-week intervention
Cognitive functions assessment with Stroop test in points. Higher scores means better outcome.
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.
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
One-repetition maximum test
Time frame: Before and after 12-week intervention
Strength assessment with one-repetition maximum test in kg
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 40880914Jozwiak B, Kleka P, Laudanska-Krzeminska I. Effect of exercise alone and in combination with time-restricted eating on cognitive health in menopausal women. Front Public Health. 2025 Aug 13;13:1640512. doi: 10.3389/fpubh.2025.1640512. eCollection 2025.
- Derived from this study: PubMed 39434160Jozwiak B, Domin R, Krzywicka M, Laudanska-Krzeminska I. Effect of exercise alone and in combination with time-restricted eating on cardiometabolic health in menopausal women. J Transl Med. 2024 Oct 21;22(1):957. doi: 10.1186/s12967-024-05738-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Time-Restricted Eating and Exercise only in people with Menopause and Cognitive Deficits, Mild, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain-derived neurotrophic factor (time frame: Before and after 12-week intervention). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06138015, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.