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

NCT ID: NCT06138015

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Menopause Cognitive Deficits, Mild

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise and Time-Restricted Eating

Group Type EXPERIMENTAL

Exercise and Time-Restricted Eating

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Exercise only

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Exercise only

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

41 Years

Maximum Eligible Age

61 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Poznan University of Physical Education

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Poznan University of Physical Education

Poznan, Greater Poland Voivodeship, Poland

Site Status

Countries

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Poland

References

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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.

Reference Type DERIVED
PMID: 40880914 (View on PubMed)

Jozwiak 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.

Reference Type DERIVED
PMID: 39434160 (View on PubMed)

Other Identifiers

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BJozwiak_PhD

Identifier Type: -

Identifier Source: org_study_id

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