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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Wellbeing; Mental Health Wellness 1; Biochemical Markers; Physical Exercise; Time Restricted Eating
• Intervention / Treatment: Other: Time restricted eating and exercise

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Pomorskie
    • Gdańsk, Pomorskie, Poland, 80-211
      • Medical University of Gdańsk Faculty of Health Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• medical checkup
• good health status

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Principal Investigator: Jędrzej Antosiewicz, Ph.D., Medical University of Gdańsk

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): March 6, 2023
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: exercise; supplementation; oxidative stress; time restricted eating; iron
• Other Study ID Numbers: 04-0246/09/306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No