AzTrials
AzTrials

Physical ExerciseNCT05229835

Effect of Time-restricted Eating and Endurance Training on Markers of the Health of Women and Men

A study testing Time restricted eating and exercise in people with Physical Exercise and Time Restricted Eating, run by Medical University of Gdansk at 1 site in Poland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The aim of this project is to demonstrate the synergistic effect of TRE and NW training on health indicators for older women. The women will be divided into four groups, i.e. Control group (CG); time-restricted eating group (TRG) which will follow 12 weeks of TRE protocol; Nordic walking training group (NWT) which… Read more about this study

Who is it for?
Ages 20 to 85 yearsHealthy volunteers can take part
What is being tested?
Time restricted eating and exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 sitePoland
Study dates
20 Jan 2022to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 20 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • medical checkup
  • good health status

Who cannot join

  • acute cardiovascular disease
  • acute respiratory disease
  • stable hypertension,
  • blood pressure over 160/100 mmHg
  • pregnancy

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Medical University of Gdańsk Faculty of Health Science

    Gdansk, Pomeranian Voivodeship, 80-211

Other trials in Poland

About this study

Official title: Effect of Time-restricted Eating and Endurance Training on Markers of the Health of Women and Men-role of Dietary Supplements

The aim of this project is to demonstrate the synergistic effect of TRE and NW training on health indicators for older women. The women will be divided into four groups, i.e. Control group (CG); time-restricted eating group (TRG) which will follow 12 weeks of TRE protocol; Nordic walking training group (NWT) which will follow 12 weeks of supervised Nordic walking training and Nordic walking training combined with a time-restricted eating group (NW-TRG). In addition, it is assumed to prove that among young men, TRE will improve adaptation to endurance training and improve the metabolism. The study will be divided into two groups: 1. a group undergoing endurance training and 2. a group combining endurance training with TRE. In all subject's changes in the metabolism of iron, tryptophan, vitamin D and lipids will be evaluated. Endocrine function of skeletal muscles, mental state and cognitive abilities of the subjects will also be examined. The investigators expect that the applied procedure of temporary restriction of food intake will be easy to apply and continue for much longer than the study period. In order to maintain this time window, test subjects will be asked to delay their breakfast and early dinner intake. In addition, it is expected that the improvement in wellbeing, vitality and a significant improvement in performance and biochemical indicators of health, especially in the NWT plus TRE group, will allow to better understand the physiology of exercise, which may result in future specific health recommendations for people of different ages.

Read the detailed description

Studies of recent years prove that one of the important causes of metabolic disorders in people is a disturbed daily cycle, which is significantly influenced by the time of eating. It has been shown that more than 50% of the examined persons consumed food for 15 hours and more during the day. Limiting food consumption to 8-10 hours, without the need to reduce food intake, the so-called time-restricted eating (TRE), resulted in a significant improvement in metabolism, decrease in body weight and cholesterol concentration, increase in insulin sensitivity and many others. A period of hunger is necessary for the body to regenerate cell structures and allows for the separation of opposing metabolic processes. This means that the period of hunger is necessary and its limitation by e.g. snacking can seriously disturb this series of processes in the human body. The results of the investigators preliminary research indicate that TRE increases the vitality of the examined persons and their desire for doing exercise. So far, there are no studies on older people, where the intervention would consist in the use of TRE and endurance training such as Nordic walking (NW). The aim of this project is to demonstrate the synergistic effect of TRE and NW training on health indicators for older women. The women will be divided into four groups, i.e. Control group (CG); time-restricted eating group (TRG) which will follow 12 weeks of TRE protocol; Nordic walking training group (NWT) which will follow 12 weeks of supervised Nordic walking training and Nordic walking training combined with a time-restricted eating group (NW-TRG). In addition, it is assumed to prove that among young men, TRE will improve adaptation to endurance training and improve the metabolism. The study will be divided into two groups: 1. a group undergoing endurance training and 2. a group combining endurance training with TRE. In all subject's changes in the metabolism of iron, tryptophan, vitamin D and lipids will be evaluated. Endocrine function of skeletal muscles, mental state and cognitive abilities of the subjects will also be examined. The investigators expect that the applied procedure of temporary restriction of food intake will be easy to apply and continue for much longer than the study period. In order to maintain this time window, test subjects will be asked to delay their breakfast and early dinner intake. In addition, it is expected that the improvement in wellbeing, vitality and a significant improvement in performance and biochemical indicators of health, especially in the NWT plus TRE group, will allow to better understand the physiology of exercise, which may result in future specific health recommendations for people of different ages.

Being tested
Time restricted eating and exercise
Keywords
time restricted eating, exercise, supplementation, iron, oxidative stress
Medical subject headings
Motor Activity, Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time restricted eating and exerciseOther

    We apply time restricted eating, exercise alone and combined

Study groups in NCT05229835
Study groupRoleWhat they receive
Time restricted eatingExperimentalTasks for participants are to fast for 14 h during the day and eat 10h during 12 weeks period
Receives: Other: Time restricted eating and exercise
Time restricted eating combined with exerciseExperimentalTasks for participants are to fast for 14 h during the day and eat 10h during 12 weeks period combined with aerobic exercise 3 times a week.
Receives: Other: Time restricted eating and exercise
ExerciseExperimentalTasks for participants are to perform aerobic exercise 3 times a week.
Receives: Other: Time restricted eating and exercise
ControlNo interventionTasks for participants are keeping their daily habits

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time restricted eating and physical performance

    The impact of this procedure on physical performance

    Measured: 12 weeks

  2. Time restricted eating and mental performance

    The impact of this procedure on mental performance

    Measured: 12 weeks

  3. Time restricted eating and iron metabolism

    The impact of this procedure on iron metabolism

    Measured: 12 weeks

  4. Time restricted eating and myokines concentration

    The impact of this procedure on myokinins concentration

    Measured: 12 weeks

  5. Time restricted eating and lipid metabolism

    The impact of this procedure on lipid metabolism

    Measured: 12 weeks

  6. Time restricted eating and glucose metabolism

    The impact of this procedure on glucose metabolism

    Measured: 12 weeks

  7. Time restricted eating and tryptophan metabolism

    The impact of this procedure on tryptophan metabolism

    Measured: 12 weeks

  8. Time restricted eating and vitamin D metabolism

    The impact of this procedure on vitamin D metabolism

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start20 Jan 2022
  3. Primary completion6 Mar 2023
  4. Study completionDec 2027 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intervention studies
Masking
Single blind
Who is masked
Investigator
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05229835
Sponsor's protocol ID
04-0246/09/306
Status last verified
Jul 2023
First submitted
14 Jan 2022
Last updated
24 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Juhas U, Budnik-Przybylska D, Borkowska A, Kortas JA, Reczkowicz J, Ziemann E, Prusik K, Flis D, Galezowska G, Kowalski K, Zychowska M, Kaczorowska-Hac B, Antosiewicz J. Changes in Mood and Tryptophan Metabolism Following a 12-Week Endurance Exercise Combined with Time-Restricted Eating in Healthy Adults. Nutrients. 2026 Sep 22;18(19):3116. doi: 10.3390/nu18193116.

    PubMed 42884568

  • Kortas JA, Reczkowicz J, Juhas U, Ziemann E, Swiatczak A, Prusik K, Olszewski S, Soltani N, Rodziewicz-Flis E, Flis D, Zychowska M, Galezowska G, Antosiewicz J. Iron status determined changes in health measures induced by nordic walking with time-restricted eating in older adults- a randomised trial. BMC Geriatr. 2024 Mar 29;24(1):300. doi: 10.1186/s12877-024-04876-8.

    PubMed 38553690

Questions about this trial

What is this clinical trial studying?

A study testing Time restricted eating and exercise in people with Physical Exercise and Time Restricted Eating, run by Medical University of Gdansk 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 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 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?

This study is still under way. Results are not available in the source record yet.

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?

Time restricted eating and physical performance (time frame: 12 weeks). The study lists 8 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 NCT05229835, 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 24 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in