NCT06138015

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:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

November 7, 2023

Last Update Submit

November 13, 2023

Conditions

MenopauseCognitive Deficits, Mild

Outcome Measures

Primary Outcomes (14)

  • 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

Study Arms (2)

Exercise and Time-Restricted Eating

EXPERIMENTAL
Behavioral: Exercise and Time-Restricted Eating

Exercise only

ACTIVE COMPARATOR
Behavioral: Exercise only

Interventions

Exercise and Time-Restricted EatingBEHAVIORAL

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 and Time-Restricted Eating
Exercise onlyBEHAVIORAL

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

Exercise only

Eligibility Criteria

Age41 Years - 61 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • perimenopause, menopause or post-menopause
  • lightly physically active or physically inactive

You may not qualify if:

  • using hormone replacement therapy or hormonal contraception
  • having significant contraindications to physical exercise or time-restricted eating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Physical Education

Poznan, Greater Poland Voivodeship, 61-871, Poland

Location

Related Publications (2)

  • 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.

    PMID: 40880914DERIVED

  • 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.

    PMID: 39434160DERIVED

MeSH Terms

Conditions

Cognition DisordersLymphoma, Follicular

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 18, 2023

Study Start

August 1, 2021

Primary Completion

January 31, 2023

Study Completion

July 1, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)