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NCT Number: NCT05229835

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Physical Exercise Behavior Biochemical Markers Fasting Feeding Behavior Intermittent Fasting Mental Health Wellness 1 Motor Activity Time Restricted Eating Wellbeing

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Gdańsk Faculty of Health Science

Gdansk, Pomeranian Voivodeship, 80-211, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • medical checkup
  • good health status

Exclusion criteria

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

Treatment and study plan

Time restricted eating and exercise

Other

We apply time restricted eating, exercise alone and combined

Primary outcomes

  1. Time restricted eating and physical performance

    Time frame: 12 weeks

    The impact of this procedure on physical performance

  2. Time restricted eating and mental performance

    Time frame: 12 weeks

    The impact of this procedure on mental performance

  3. Time restricted eating and iron metabolism

    Time frame: 12 weeks

    The impact of this procedure on iron metabolism

  4. Time restricted eating and myokines concentration

    Time frame: 12 weeks

    The impact of this procedure on myokinins concentration

  5. Time restricted eating and lipid metabolism

    Time frame: 12 weeks

    The impact of this procedure on lipid metabolism

  6. Time restricted eating and glucose metabolism

    Time frame: 12 weeks

    The impact of this procedure on glucose metabolism

  7. Time restricted eating and tryptophan metabolism

    Time frame: 12 weeks

    The impact of this procedure on tryptophan metabolism

  8. Time restricted eating and vitamin D metabolism

    Time frame: 12 weeks

    The impact of this procedure on vitamin D metabolism

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
Feb 8, 2022
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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