The effect of different intensities of exercise on intestinal and immune function in healthy young men in the age of 18-35 years old

ISRCTN ISRCTN13656034
DOI https://doi.org/10.1186/ISRCTN13656034
Secondary identifying numbers NL 49412.081.14
Submission date
20/03/2017
Registration date
03/11/2017
Last edited
03/01/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Current nutrition research aims to improve the health state and prevent or delay disease. It is widely accepted that individual’s health and well-being are strongly related to increased intestinal permeability. Improving intestinal permeability by means of food products could thus be a promising step in prevention and successful treatment of diseases related to Gastro-Intestinal (GI) permeability. However well-defined ‘stress’ models – in healthy subjects - with relevant biomarkers for GI permeability and intestinal function to evaluate nutritional effects, are not yet available. It is known that moderate to intense continuous exercise increases intestinal permeability and leads to inflammatory responses. Which intensity is necessary to induce these effects is, however, unknown. In order to develop a commonly accepted and standardized physical stress model that can be applied to a broad population, the current study will compare three exercise protocols of different intensity. Furthermore, the role of proper hydration is not well documented to date. Therefore we also investigate the effect of hydration on intestinal permeability.

Who can participate?
Healthy moderately trained young men in the age of 18-35 years and a body mass of 20-25 kg/m2.

What does the study involve?
During preliminary testing the maximal aerobic capacity and maximal capacity (VO2max/Wmax) are determined. Subjects will start the study period in the rest condition and will cycle randomly allocated 4 exercise protocols: 1h at 70% Wmax; 1h at 70% Wmax in dehydrated condition; 1h at 50% Wmax and 1h alternating 55%/85% Wmax. Both 70% Wmax protocols, hydrated and dehydrated were allocated as a block. At the end of rest and the exercise subjects are asked to drink a multisugar and an amino acid solution. Before and after rest and exercise at several time point up to 24h, blood, urine and saliva samples are taken for intestinal function and immune markers. Blood samples are also taken halfway exercise. Subjects are asked to keep logs on training, illness and dietary.

What are the possible benefits and risks of participating?
The intensity is well-tolerated in this group of moderately trained cyclists and they can benefit from the measurement of the Wmax and VO2max to improve and optimize their training program and progress. The health risks associated for the subjects are minor. They will have to perform moderately to intense exercise which may result in fatigue, and can give some muscle soreness afterwards.

Where is the study run from?
The GRINTA! study takes place at the exercise lab of Wageningen University & Research Centre in Wageningen.

When is the study starting and how long is it expected to run for?
September 2014 to December 2014

Who is funding the study?
Netherlands Organisation for Scientific Research (Netherlands)

Who is the main contact?
1. Shirley Kartaram MSc shirley.kartaram@hu.nl
2. Raymond Pieters PhD raymond.pieters@hu.nl

Contact information

Ms Shirley Kartaram
Public

Utrecht University of Applied Sciences
Heidelberglaan 7
Utrecht
3584 CS
Netherlands

Study information

Study designSingle-centre randomized coss over design
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Home
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effect of different intensities of exercise on biomarkers of GastRo-INTestinal Activity and immune function in healthy young men
Study acronymGRINTA!
Study objectivesThe aims of this study are:
1. To compare the effect of different exercise protocols on intestinal permeability and on plasma levels of glutamine and glutamine-derived amino acids, in healthy young men
2. To assess the effect of different exercise protocols on immune - and gut barrier function markers and inflammation in plasma, urine and saliva
3. To establish the effect of proper hydration on gastro-intestinal permeability during intense exercise
Ethics approval(s)Ethical Committee Wageningen University, 17/06/2014, ref:14/16
Health condition(s) or problem(s) studiedGastro-intestinal function and immune response
InterventionFifteen healthy young men (20-35 yrs, VO2 max 56.9 ± 3.9 ml. kg-1 min-1 ) performed in a cross-over design five experimental protocols of one hour with different intensity and/or hydration status: 1) rest (group 1), 2) and 3) 70% Wmax respectively euhydrated (group 2) and dehydrated (group 3), 4) 50% Wmax (group 4) and, 5) intermittent 85/55% Wmax in blocks of 2 min (group 5). The wash out period between two experimental protocols was one week. Each subject started with rest (group 1). After one week wash out each subject performed on individual base a randomly assigned exercise protocol (groups 2-5). The 70% Wmax hydrated and dehydrated conditions were randomized as a block.

At the end of rest and the exercise subjects are asked to drink a multisugar and an amino acid solution. Before and after rest and exercise at several time point up to 24h, blood, urine and saliva samples are taken for intestinal function and immune markers. Blood samples are also taken halfway exercise. Subjects are asked to keep logs on training, illness and dietary.
Intervention typeMixed
Primary outcome measure1. Intestinal permeability (lactulose/rhamnose ratio) is measured using HPAEC (with pulsed electrochemical detection) at baseline, and each hour after rest and exercise up to 5 hours
2. Plasma levels of glutamine is measured using the UFLC (ultra fast liquid chromatography) at baseline, during (30 min) and after rest and exercise (60, 90, 120, 180, 360 min) up to 24 hours
3. Glutamine-derived amino acids are measured using the UFLC (ultra-fast liquid chromatography) at baseline, during (30 min) and after rest and exercise (60, 90, 120, 180, 360 min) up to 24 hours
Secondary outcome measuresGastro-intestinal integrity and inflammation markers are measured using ELISA at baseline, during (30 min) and after rest and exercise (60, 90, 120, 180, 360 min) up to 24 hours.
Overall study start date31/01/2014
Completion date05/12/2014

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit35 Years
SexMale
Target number of participants15
Total final enrolment15
Key inclusion criteria1. Male
2. Generally healthy
3. Recreational athlete with at least two years of cycling experience of at least twice a week
4. 18-35 years old
5. Meeting criteria of valid max-test
6. Body mass index (BMI) 20-25 kg/m2
7. Veins suitable for blood sampling at inspection
Key exclusion criteria1. Known symptoms of immune diseases such as diabetes, celiac disease, gastric disease or cystic fibrosis
2. Known symptoms of intestinal diseases such as Crohn’s disease, ulcerosis, irritable bowel syndrome or cystic fibrosis
3. Smoking
4. Use of hard drugs
5. Use of specific medicines:
6. Chronic use of NSAIDs: aspirin, ibuprofen, etc.
7. Drugs for gastric and/or intestinal function
8. Participation in other scientific studies
9. Blood donation during the last six weeks prior to the start of the study
Date of first enrolment01/09/2014
Date of final enrolment01/11/2014

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Wageningen University, Division Human Nutrition
Bomenweg 2
6307 HD Wageningen
6307 HD
Netherlands

Sponsor information

Utrecht University of Applied Sciences
University/education

Heidelberglaan 7
Utrecht
3584 CS
Netherlands

Website http://www.innovativetesting.nl/
ROR logo "ROR" https://ror.org/028z9kw20

Funders

Funder type

Research organisation

The Netherlands Organisation for Scientific Research -Foundation Innovation Alliance

No information available

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe current data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2019 26/11/2020 Yes No
Other publications 04/09/2020 03/01/2023 Yes No

Editorial Notes

03/01/2023: Publication reference added.
26/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.