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

July 21, 2023 updated by: Medical University of Gdansk

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-211
        • Medical University of Gdańsk Faculty of Health Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • medical checkup
  • good health status

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Time restricted eating
Tasks for participants are to fast for 14 h during the day and eat 10h during 12 weeks period
Other: Time restricted eating and exercise
We apply time restricted eating, exercise alone and combined
Experimental: Time restricted eating combined with exercise
Tasks 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.
Other: Time restricted eating and exercise
We apply time restricted eating, exercise alone and combined
Experimental: Exercise
Tasks for participants are to perform aerobic exercise 3 times a week.
Other: Time restricted eating and exercise
We apply time restricted eating, exercise alone and combined
No Intervention: Control
Tasks for participants are keeping their daily habits

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time restricted eating and physical performance
Time Frame: 12 weeks
The impact of this procedure on physical performance
12 weeks
Time restricted eating and mental performance
Time Frame: 12 weeks
The impact of this procedure on mental performance
12 weeks
Time restricted eating and iron metabolism
Time Frame: 12 weeks
The impact of this procedure on iron metabolism
12 weeks
Time restricted eating and myokines concentration
Time Frame: 12 weeks
The impact of this procedure on myokinins concentration
12 weeks
Time restricted eating and lipid metabolism
Time Frame: 12 weeks
The impact of this procedure on lipid metabolism
12 weeks
Time restricted eating and glucose metabolism
Time Frame: 12 weeks
The impact of this procedure on glucose metabolism
12 weeks
Time restricted eating and tryptophan metabolism
Time Frame: 12 weeks
The impact of this procedure on tryptophan metabolism
12 weeks
Time restricted eating and vitamin D metabolism
Time Frame: 12 weeks
The impact of this procedure on vitamin D metabolism
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Gdansk

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jędrzej Antosiewicz, Ph.D., Medical University of Gdansk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 04-0246/09/306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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