Primary Objective: Can the chance at and/or intensity of gastrointestinal symptoms during exercise be influenced by probiotics supplementation in recreationally trained endurance athletes who experience these symptoms and can performance be enhanced…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
veranderingen in samenstelling darmmicrobioom/metabolieten en voorkomen maagdarmklachten bij gezonde personen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study objective is to study whether fourteen weeks of supplementation
with a probiotics supplement can influence the occurrence and severity of
gastrointestinal symptoms during and directly after endurance exercise and the
running performance in recreationally trained endurance athletes. Performance
is: distance in km (on a 30 minute running time trial, preceded by two times 30
minutes submaximal running) and maximum speed in km/h and VO2max (on a maximal
incremental running exercise test).
Secondary outcome
Secundary study parameters are the possible differences in changes in
composition of the microbiota and possible differences in changes in the
metabolites in the stool sample before and after the supplementation period in
the experimental and control group. Changes in the microbiota can be changes in
the occurrence of different bacterial strains and the percentual contribution
to the total amount of all the strains together. Changes in metabolites can be
changes in the occurrence of different metabolites and their percentual change.
Other study parameters that will be taken into account are:
1) Body temperature, calculated by core temperature and skin temperature, and
hydration status during the performance tests;
2) Training modality, training volume, training intensity and a subjective
measure of training intensity perception (RPE) during the supplementation
period;
3) The occurrence of gastrointestinal symptoms during the supplementation
period;
4) Outcome scores of the weekly completed POMS questionnaire during the
supplementation period;
5) Habitual food pattern before and after the supplementation period;
6) Height and body mass.
Background summary
Endurance exercise, such as running a marathon, is becoming increasingly
popular. In addition to the many positive health effects of endurance exercise,
it can also be accompanied by gastrointestinal symptoms. For example, around
30-90% of runners suffer from gastrointestinal symptoms during or in the hours
after intensive/endurance running. The occurrence of gastrointestinal symptoms
is probably due to the redistribution of blood volume, resulting in less blood
supply to the digestive tract and a less functioning intestinal barrier.
Because the intestinal barrier functions less, endotoxins can enter the
bloodstream and cause inflammatory reactions. Running in the heat causes extra
redistribution of the blood volume, because extra blood is needed for cooling
of the body. It is known that the gut microbiota affect food digestion, but
also the functioning of the cells that line the intestinal wall and the
connections between these cells. It is possible that runners with
gastrointestinal symptoms face a different composition of the gut microbiota
and / or metabolites during endurance exercise compared to runners without any
complaints, as a result of which the gut barrier functions less well and
problems may occur. Many positive effects have been attributed to the use of
probiotics, including the reduction of gastrointestinal symptoms during
endurance exercise, probably due to improvement in intestinal permeability.
Hence, the main goal of our research project is to investigate whether the
chance of and/or intensity of gastrointestinal symptoms during endurance
exercise and the exercise performance can be influenced by probiotics
supplementation in recreationally trained endurance athletes. This will be
studied in relation to the composition of the gut microbiota and / or
metabolites.
Study objective
Primary Objective:
Can the chance at and/or intensity of gastrointestinal symptoms during exercise
be influenced by probiotics supplementation in recreationally trained endurance
athletes who experience these symptoms and can performance be enhanced?
Secondairy Objective: Can the composition and function of the gut microbiota of
recreationally trained athletes that experience gastrointestinal symptoms
during exercise be positively influenced by probiotics supplementation?
Study design
A double-blind randomized placebo-controlled trial will be performed with
experienced endurance runners to investigate the effect of probiotics
supplementation on occurrence and intensity of gastrointestinal symptoms during
exercise and on performance. The effect on the composition and function of the
gut microbiota will also be studied. The duration of the supplementation
period, with Ecologic® PERFORMANCE supplements, is fourteen weeks. Standardized
maximal incremental exercise tests will be performed before and after the
supplementation period, as well as two performance tests (before) and one
performance test (after). One performance test before will be used to
familiarize the participant. During the performance tests submaximal exercise
will be performed for 1h after which a 30 minute time trial will be performed.
The measurements before and after the supplementation period will be performed
on separate days with at least 48 hours of relative rest in between. During the
supplementation period training diaries, a POMS questionnaire and some
questionnaires about food habits will be completed.
Intervention
Fourteen weeks of supplementation with Ecologic® PERFORMANCE probiotics
supplements (or placebo). The probiotics supplement consists of a matrix with 6
bacterial strains: Bifidobacterium bifidum W23, Bifidobacterium lactis W51,
Enterococcus faecium W54, Lactobacillus acidophilus W22, Lactobacillus brevis
W63, Lactococcus lactis W58. They will be used within recommended dosage,
1*1010 CFU/daily dose, and not in combination with other products.
Study burden and risks
The maximal incremental exercise test (2 times) consists of a warming-up
followed by incremental increase in running velocity until voluntary
exhaustion. The performance tests (3 times) consists of 60 minutes of
submaximal running followed by a time trial of 30 minutes in which participants
need to accomplish as much distance as possible. Only participants that are
healthy (low risk based on anamnesis form) and endurance trained, and thus used
to the same intensity of exercise several times a week, will be included.
During exercise tests in warm conditions, the injury risk is not higher
compared to their normal training and races in the same conditions. In case
participants might not feel well or experience unbearable discomfort, they can
stop the test at all times. Participants will fill in a food frequency twice
(start and end of suppletion period) questionnaire which will be sended by the
Wageningen University. Participants will also fill in a questionnaire about
gastrointestinal symptoms directly after and 24 hours after the performance
tests. They hand in a stool sample before and after the supplementation period.
Part of the stool sample will be sended by mail to MyMicroZoo. Participants
will be asked to complete a food dairy prior to the tests and to maintain a
training dairy during the fourteen weeks of supplementation and also fill in
the POMS questionnaire weekly.
In the Human Performance Laboratory of the Faculty of Behavioural and Human
Movement Sciences of the Vrije Universiteit Amsterdam, where the tests will be
executed, performance tests in warm conditions are executed regularly (e.g.
VCWE FGB-VU-2018-050) and health risks related to the experimental protocol are
minor for the participant since they are already well-trained and the exercise
intensity will be relatively well-tolerated, since they are used to similar
efforts. Relative humidity will be lower compared to average Dutch relative
humidity at the same temperature.
Probiotics supplements are freely available at the market, also the Ecologic®
PERFORMANCE supplements are available via internet and can be bought at several
farmacies. Check
https://www.winbiotic.nl/consument/Verkrijgbaarheid/via-onze-partners.html.,
therefore it is very likely that some athletes will already know the
supplements or know people that use the supplements. The same supplement has
already been used in another study (Lamprecht et al, 2012) in the same dosage
and no adverse effects were reported.
Participants will receive a small financial compensation, ¤50,00 + travel
expenses. Benefits might the chance on a reduced risk of occurrence of
gastrointestinal symptoms might be of value for potential participants.
Darwinweg 24
Leiden 2333CR
NL
Darwinweg 24
Leiden 2333CR
NL
Listed location countries
Age
Inclusion criteria
healthy male (No females because: menstrual cycle of women is an additional
confounder of the possible relationship between intestinal microbiota and the
development of gastrointestinal symptoms during endurance exertion. And to
exclude possible gender-related effects of probiotics on exercise-induced
gastrointestinal symptoms, because females show less effect on the incidence
and severity of upper respiratory tract infections, this might also be the case
for probiotics and the GI symptoms).
18-45 years old;
Dutch descent; Only men of Dutch descent (which is both parents from Dutch
descent) are included, because ethnicity influences the gut microbiota;
maximal oxygen uptake (VO2max) * 45 mL*kg-1*min-1 (based on an incremental
exercise test you are considered recreationally trained);
an average training frequency of at least three times per week;
a low risk profile based on a health-history form;
regular occurrence of exercise-induced gastrointestinal symptoms.
Exclusion criteria
smoking;
a diagnosis of gastrointestinal disorders (e.g. Crohn*s disease, celiac
disease, diagnosed with irritable bowel syndrome);
use of antidepressants in the 6 months prior to the start of the study;
use of antibiotics, antivirals, antifungals, antiparasitic agents,
prebiotics/probiotics supplements in the 6 months prior to the start of the
study.
use of probiotic food products like probiotic yoghurt and/or probiotic (dairy)
drinks in the two weeks prior to the start of the study and during the study.
Examples of these products are: Actimel, Activia, Kefir, Yakult. Prebiotic
supplements and probiotic supplements are also not allowed.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03959722 |
| CCMO | NL69974.081.19 |