The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05229835
Recruitment Status : Active, not recruiting
First Posted : February 8, 2022
Last Update Posted : July 24, 2023
Sponsor:
Information provided by (Responsible Party):
Medical University of Gdansk

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Physical Exercise Time Restricted Eating Mental Health Wellness 1 Wellbeing Biochemical Markers Other: Time restricted eating and exercise Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention studies
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Time-restricted Eating and Endurance Training on Markers of the Health of Women and Men-role of Dietary Supplements
Actual Study Start Date : January 20, 2022
Actual Primary Completion Date : March 6, 2023
Estimated Study Completion Date : December 2027
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05229835


Locations
Layout table for location information
Poland
Medical University of Gdańsk Faculty of Health Science
Gdańsk, Pomorskie, Poland, 80-211
Sponsors and Collaborators
Medical University of Gdansk
Investigators
Layout table for investigator information
Principal Investigator: Jędrzej Antosiewicz, Ph.D. Medical University of Gdansk
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT05229835    
Other Study ID Numbers: 04-0246/09/306
First Posted: February 8, 2022    Key Record Dates
Last Update Posted: July 24, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Gdansk:
time restricted eating
exercise
supplementation
iron
oxidative stress