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Active, not recruitingNCT05229835Updated Jul 24, 2023

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

An interventional study of Time restricted eating and exercise in Physical Exercise, Time Restricted Eating and Mental Health Wellness 1, sponsored by Medical University of Gdansk. Active, not recruiting at 1 site in Poland. Open to participants aged 20 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by Medical University of Gdansk · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Physical Exercise
  • Time Restricted Eating
  • Mental Health Wellness 1
  • Wellbeing
  • Biochemical Markers

Keywords

  • time restricted eating
  • exercise
  • supplementation
  • iron
  • oxidative stress
03

In context

Lead sponsor

Medical University of Gdansk is the lead sponsor of 130 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • medical checkup
  • good health status

Exclusion criteria

Exclusion Criteria:

  • acute cardiovascular disease
  • acute respiratory disease
  • stable hypertension,
  • blood pressure over 160/100 mmHg
  • pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
300 participants (estimated)

Study arms

  • 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

  • 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

  • Experimental
    Exercise

    Tasks for participants are to perform aerobic exercise 3 times a week.

    Other: Time restricted eating and exercise

  • No intervention
    Control

    Tasks for participants are keeping their daily habits

Interventions

  • OtherTime restricted eating and exercise

    We apply time restricted eating, exercise alone and combined

06

What researchers measure

Primary outcomes

  1. Time restricted eating and physical performance

    The impact of this procedure on physical performance

    Time frame: 12 weeks

  2. Time restricted eating and mental performance

    The impact of this procedure on mental performance

    Time frame: 12 weeks

  3. Time restricted eating and iron metabolism

    The impact of this procedure on iron metabolism

    Time frame: 12 weeks

  4. Time restricted eating and myokines concentration

    The impact of this procedure on myokinins concentration

    Time frame: 12 weeks

  5. Time restricted eating and lipid metabolism

    The impact of this procedure on lipid metabolism

    Time frame: 12 weeks

  6. Time restricted eating and glucose metabolism

    The impact of this procedure on glucose metabolism

    Time frame: 12 weeks

  7. Time restricted eating and tryptophan metabolism

    The impact of this procedure on tryptophan metabolism

    Time frame: 12 weeks

  8. Time restricted eating and vitamin D metabolism

    The impact of this procedure on vitamin D metabolism

    Time frame: 12 weeks

07

Study locations

1 site
  • Medical University of Gdańsk Faculty of Health Science
    Gdańsk, Pomorskie 80-211, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05229835
Lead sponsor
Medical University of Gdansk
Responsible party
Sponsor
First posted
Feb 8, 2022
Start date
Jan 20, 2022
Primary completion
Mar 6, 2023
Completion
Dec 2027 (estimated)
Last update
Jul 24, 2023

Study contacts

Jędrzej Antosiewicz, Ph.D.
principal investigator · Medical University of Gdansk

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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