Effect of Time-restricted Eating and Endurance Training on Markers of the Health of Women and Men
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2022
CompletedStudy Start
First participant enrolled
January 20, 2022
CompletedFirst Posted
Study publicly available on registry
February 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedJuly 24, 2023
July 1, 2023
1.1 years
January 14, 2022
July 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Time restricted eating and physical performance
The impact of this procedure on physical performance
12 weeks
Time restricted eating and mental performance
The impact of this procedure on mental performance
12 weeks
Time restricted eating and iron metabolism
The impact of this procedure on iron metabolism
12 weeks
Time restricted eating and myokines concentration
The impact of this procedure on myokinins concentration
12 weeks
Time restricted eating and lipid metabolism
The impact of this procedure on lipid metabolism
12 weeks
Time restricted eating and glucose metabolism
The impact of this procedure on glucose metabolism
12 weeks
Time restricted eating and tryptophan metabolism
The impact of this procedure on tryptophan metabolism
12 weeks
Time restricted eating and vitamin D metabolism
The impact of this procedure on vitamin D metabolism
12 weeks
Study Arms (4)
Time restricted eating
EXPERIMENTALTasks for participants are to fast for 14 h during the day and eat 10h during 12 weeks period
Time restricted eating combined with exercise
EXPERIMENTALTasks 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.
Exercise
EXPERIMENTALTasks for participants are to perform aerobic exercise 3 times a week.
Control
NO INTERVENTIONTasks for participants are keeping their daily habits
Interventions
We apply time restricted eating, exercise alone and combined
Eligibility Criteria
You may qualify if:
- medical checkup
- good health status
You may not qualify if:
- acute cardiovascular disease
- acute respiratory disease
- stable hypertension,
- blood pressure over 160/100 mmHg
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Gdańsk Faculty of Health Science
Gdansk, Pomeranian Voivodeship, 80-211, Poland
Related Publications (1)
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.
PMID: 38553690DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jędrzej Antosiewicz, Ph.D.
Medical University of Gdansk
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2022
First Posted
February 8, 2022
Study Start
January 20, 2022
Primary Completion
March 6, 2023
Study Completion (Estimated)
December 1, 2027
Last Updated
July 24, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share