NCT06138015

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

Completed NA Last updated 18 November 2023

What this trial tests

NA trial testing Exercise and Time-Restricted Eating in Menopause in 80 participants. Completed in 1 July 2023.

Timeline

1 August 2021

Primary endpoint
31 January 2023

1 July 2023

Quick facts

Lead sponsor	Poznan University of Physical Education
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	80
Start date	1 August 2021
Primary completion	31 January 2023
Estimated completion	1 July 2023
Sites	1 location across Poland

Drugs / interventions tested

• Exercise and Time-Restricted Eating
• Exercise only

Conditions studied

• Menopause — all drugs for Menopause →
• Cognitive Deficits, Mild — all drugs for Cognitive Deficits, Mild →

Sponsor

Poznan University of Physical Education

Who can join

Adults 41 to 61, female only, with Menopause or Cognitive Deficits, Mild. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of exercise alone and in combination with time-restricted eating on cardiometabolic health in menopausal women.
   Jóźwiak B, Domin R, Krzywicka M, Laudańska-Krzemińska I. · · 2024 · cited 5× · PMID 39434160 · DOI 10.1186/s12967-024-05738-y
2. Effect of exercise alone and in combination with time-restricted eating on cognitive health in menopausal women.
   Jóźwiak B, Kleka P, Laudańska-Krzemińska I. · · 2025 · cited 1× · PMID 40880914 · DOI 10.3389/fpubh.2025.1640512
3. Time-Restricted Eating Combined with Exercise Reduces Menopausal Symptoms and Improves Quality of Life More than Exercise Alone in Menopausal Women: A Quasi-Randomized Controlled Trial.
   Jóźwiak B, Szulc A, Laudańska-Krzemińska I. · · 2025 · PMID 41156526 · DOI 10.3390/nu17203274