The primary objective of this study is to investigate the effect of a six-week period personalized food intervention with prebiotic supplementation on intense exercise performance in healthy, recreationally active adults. Further, this study has…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
spierfunctie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The most important parameter is the outcome of the exercise test until
exhaustion.
Secondary outcome
- the fecal microbiota
- biomarkers of metabolic health; fasting glucose, insulin and SCFA
- SCFA concentration in the droppings
- permeability of the intestines after a single exercise test
- permeability of the intestines after intervention
Background summary
Nutritional advice for athletes before, during and after exercise has been well
established. In practice an athlete's diet consists mainly of simple and easily
digestible carbohydrates and relatively few fibers. This is associated with a
reduced diversity of the gut microbiota. The role of the composition of the gut
microbiota has long been underestimated, but in recent years it is brought to
the attention that the possible influence exerted by gut microbiota composition
on skeletal muscle metabolism and function works through the gut-muscle axis.
Previous animal studies have shown that a change in gut microbiota directly
affects the composition and functioning of skeletal muscle. through the
production of SCFA. These, once included in circulation, could potentially act
as endocrine mediators with a significant impact on metabolism and skeletal
muscle function. Therefore, we will investigate if the intake of prebiotics can
result in increased SCFA production which may lead to enhanced exercise
performance.
Study objective
The primary objective of this study is to investigate the effect of a six-week
period personalized food intervention with prebiotic supplementation on intense
exercise performance in healthy, recreationally active adults.
Further, this study has five secondary objectives:
- First to compare the effect of six weeks daily prebiotic supplementation on
intestinal microbiota.
- Second, to compare the effect of six weeks daily prebiotic supplementation on
biomarkers of metabolic health.
- Third, to compare the effect of six weeks daily prebiotic supplementation on
faecal SCFA concentration.
- Fourth, to determine to what extend a single bout of intense endurance
exercise affects intestinal permeability.
- Fifth, to assess whether six weeks of daily prebiotic
Study design
This study has a single blinded, randomized, placebo-controlled, parallel
design
Intervention
The intervention will be carried out with 5 different prebiotics supplements
suitable for human consumption. Thefollowing prebiotics are selected
(commercially available):
1. Dietary intake or galacto-oligosaccharides (GOS).
2. Dietary intake or resistant starch from potatoes (RPS).
3. Dietary intake or Fructo-oligosaccharides (FOS)
4. Dietary intake or arabinoxylo-oligosaccharides (AXOS)
5. Dietary intake or inulin.
The placebo product contains only maltodextrin.
The products are given to the participants during an intervention period of 6
weeks. Participants must take test products twice a day.
Study burden and risks
There are small burdens volunteers can experience during this study. After the
screening visit, participants will have to visit the Metabolic Research Unit
Maastricht five times. In total, a participant will spend approximately 2 hours
at the university facility. They will have to take prebiotic supplementation
two times daily for a time period of six weeks; the supplements used have been
proven to be safe for human use. During three visits spread over 7 weeks, a
total of 54 mL blood will be sampled by venepuncture via an evacuated tube
system, which may lead to minor discomfort and/or a small hematoma at the site
of puncture. During two of these visits an intense exercise test will be
performed. Before the start of the study, a VO2max test will be performed. The
performance tests can possibly lead to muscle soreness for up to two days.
Subjects will bring faecal samples which is collected at home. Moreover,
questionnaires will have to be filled out at several occasions during this
study. Except general information about their health status during the
screening visit, subjects may not perceive direct benefits as a result of
participating in this trial, since effects may be small and of temporary
nature. An indirect effect of this study will be the insights which will be
gathered about the effectiveness of the study product, and this may contribute
to development in new food products for healthy and diseased humans.
Nassaustraat 36
Venlo 5911AA
NL
Nassaustraat 36
Venlo 5911AA
NL
Listed location countries
Age
Inclusion criteria
1. Aged from 18- 40 years
2. 18.5 < BMI < 25 kg*m-2
3. Weight-stable for at least 90 days prior to participation (no change in
bodyweight, i.e. < 3kg).
4. Recreational active (performing non-competitive physical endurance exercise
at least two times per week with a minimum duration of 60 minutes per exercise
bout)
Exclusion criteria
1. Smoking
2. Performing regular resistance training (3+ times per week, carrying out
progressive training)
3. Subject following an overly imbalanced or restrictive diet as per
nutritional advice
4. Concurrent systemic disease and/or laboratory abnormalities considered by
investigators to be detrimental for the participants safety or potentially
interfering with the study procedures and/or study outcome
5. Hypertension (according to WHO criteria) and/or cardiovascular disease
6. Abdominal surgery interfering with gastrointestinal function, upon judgement
of the medical doctor, who will decide in-or exclusion based on the surgery
applied
7. Participants who received antibiotics in the previous 90 days to the start
of study
8. Use of other medication will be reviewed by a medical doctor, who will
decide on in- or exclusion based on the drug(s) used
9. Use of laxatives within 14 days prior to the study
10. Using medications for gastric or intestinal complaints
11. Drug use, interfering with any of the outcome parameters of this study; to
be decided by the person who is medically responsible for this study
12. Self-admitted lactose intolerance
13. Having donated blood in the 3 months prior to the study
14. Administration of probiotic or prebiotic supplements, investigational drugs
or participation in any scientific intervention study, which may interfere with
this study (to be decided by the principle investigator), in the 14 days prior
to the study
15. History of side effects towards intake of prebiotic supplements
16. Use of proton pump inhibitors
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 |
|---|---|
| CCMO | NL73083.068.20 |