Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05229835 |
| Other study ID # |
04-0246/09/306 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2022 |
| Est. completion date |
December 2027 |
Study information
| Verified date |
July 2023 |
| Source |
Medical University of Gdansk |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
