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

NCT ID: NCT05229835

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2027-12-31

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Time restricted eating

Tasks for participants are to fast for 14 h during the day and eat 10h during 12 weeks period

Group Type: EXPERIMENTAL

Time restricted eating and exercise

Intervention Type: OTHER

We apply time restricted eating, exercise alone and combined

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.

Group Type: EXPERIMENTAL

Time restricted eating and exercise

Intervention Type: OTHER

We apply time restricted eating, exercise alone and combined

Exercise

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

Group Type: EXPERIMENTAL

Time restricted eating and exercise

Intervention Type: OTHER

We apply time restricted eating, exercise alone and combined

Control

Tasks for participants are keeping their daily habits

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Time restricted eating and exercise

We apply time restricted eating, exercise alone and combined

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• medical checkup
• good health status

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Gdansk

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jędrzej Antosiewicz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Gdansk

Locations

Medical University of Gdańsk Faculty of Health Science

Gdansk, Pomeranian Voivodeship, Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 38553690 (View on PubMed)

Other Identifiers

04-0246/09/306

Identifier Type: -

Identifier Source: org_study_id