Dietary prebiotic interventions for athlete health
| ISRCTN | ISRCTN17050527 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17050527 |
- Submission date
- 11/08/2022
- Registration date
- 16/08/2022
- Last edited
- 16/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Elite rugby union players follow physiologically and psychologically demanding training schedules, with frequent competitive matches, limited recovery time, and regular international travel. Collectively, these stressors may impair immunity and increase the risk of acute upper respiratory symptoms (URS) (e.g. cough, sneezing, sore throat, and nasal congestion) and gastrointestinal symptoms (GIS) (e.g. bloating, belching, flatulence, nausea, and diarrhoea). The profile, genetic material, and functional activity of the gut microbial community (the gut microbiome) has a substantial influence on immune function. Manipulation of the gut microbiome is possible through dietary intervention, most commonly through pro- or prebiotic dietary supplements. This may provide a potential strategy to help reduce URS and GIS in team sport athletes.
Therefore, the aim of this study is to assess the effects of a 24-week prebiotic supplementation on the severity, duration and incidence of URS and GIS, and immune parameters in male elite rugby union players.
Who can participate?
Elite rugby union players playing in the English Premiership
What does the study involve?
Participants will be allocated to one of two groups, with an equal chance of participants being in either group (like tossing a coin) but with an even distribution based on body mass and playing position between the two groups. For 24 weeks, one group of participants will receive a daily prebiotic powder, in single-dose sachets, and the participants in the other group will receive a daily identical-looking and tasting powder, but with no active medicine. Participants and researchers will not know which treatment the participant has received during the study.
What are the possible benefits and risks of participating?
Participants taking part in the study may benefit from the provision of information pertaining to their gut microbiota. Participants may also benefit from reduced illness rates throughout the season, increasing training and match day availability. Advice will also be provided on nutrition for enhancing the gut microflora and immunity.
Some discomfort may be experienced during venepuncture. Following the removal of the needle, pressure will be applied to the punctured area for approximately 10 minutes to avoid the development of a local haematoma. The venepuncture procedure has been risk assessed, and, in relation to current experience at NTU, it is safe. Staff who perform the procedure are appropriately trained and sterile procedures are used at all times. Safe laboratory working practices are followed and all staff have current Hepatitis B vaccination. Only two attempts at venepuncture will be made.
Although rare, prebiotics may cause dose-dependent gastrointestinal side effects such as bloating. Participants who present with symptoms will be monitored by the Club medic and, where considered necessary, removed from the study. Any adverse events will be reported to the Club medic and feedback directly to prebiotic manufacturer Clasado Biosciences.
Where is the study run from?
Nottingham Trent University (UK)
When is the study starting and how long is it expected to run for?
From April 2019 to February 2020
Who is funding the study?
Nottingham Trent University (UK) with the dietary supplements supplied by Clasado Biosciences Ltd (UK)
Who is the main contact?
Dr Neil Williams, neil.williams@ntu.ac.uk
Contact information
Principal Investigator
Nottingham Trent University
SHAPE Research Centre
School of Science and Technology
Clifton Campus
Nottingham
NG11 8NS
United Kingdom
 ORCID ID |
0000-0002-2607-4572 |
|---|---|
| Phone | +44 (0)1158485535 |
| neil.williams@ntu.ac.uk |
Study information
| Study design | Single centre, interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effects of 24-week prebiotic intervention on self-reported upper respiratory symptoms, gastrointestinal symptoms, and markers of immunity in elite rugby union players. |
| Study objectives | The 24-week prebiotic (B-GOS) supplementation will reduce the severity, duration, and incidence of upper respiratory and gastrointestinal illness symptoms, and enhance immune parameters (sIgA, and plasma concentrations of C-reactive protein and TNF-α) in elite rugby union players during a competitive season. |
| Ethics approval(s) | Approved 19/06/2019, Nottingham Trent University Human Ethics Committee (Nottingham Trent University, School of Science and Technology, Clifton Campus, NG11 8NS; +44 115 84 83461; Dianne.Levey@ntu.ac.uk), ref: 612 |
| Health condition(s) or problem(s) studied | Prevention of upper respiratory and gastrointestinal illness symptoms in elite rugby union players |
| Intervention | Players will be randomised to consume either 2.9 g/day of the commercially available B-GOS (Bimuno, Clasado Biosciences Ltd, Reading, UK) or 2.9 g/day placebo (maltodextrin) provided as a powder in single dose sachets (Clasado Biosciences Ltd, Reading, UK). Both supplements were identical in taste and colour and blinded at the site of manufacture (Clasado Biosciences Ltd). Participants were matched based on age, body mass, and playing position. Block randomisation was used to randomise players to either the prebiotic group, or placebo group. |
| Intervention type | Supplement |
| Primary outcome measure | Daily upper respiratory symptoms measured using the Jackson questionnaire daily over the 24-week intervention |
| Secondary outcome measures | 1. Gut symptoms measured using a modified visual analog scale assessment tool (Gaskell et al., 2019) weekly over the 24-week intervention 2. Plasma TNFa concentrations measured using ELISA from samples taken at baseline, 12, and 24 weeks 3. Plasma CRP concentrations measured using ELISA from samples taken at baseline, 12, and 24 weeks 4. Salivary IgA concentrations measured using ELISA from samples taken at baseline, 12, and 24 weeks |
| Overall study start date | 24/04/2019 |
| Completion date | 24/02/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 40 |
| Total final enrolment | 33 |
| Key inclusion criteria | 1. Elite rugby union players playing in the English Premiership 2. Non-smokers 3. No history of gastrointestinal illness 4. Not regularly consuming foods enriched with probiotics, prebiotics, or vitamins |
| Key exclusion criteria | 1. Routine consumption of prebiotic, and/or probiotic supplements 2. Take a daily dose of aspirin or other NSAIDs 3. Intake of drugs that affect gastrointestinal mobility, laxatives in the 4 weeks before the study 4. Vegetarian or vegan diet 5. Previously diagnosed with COPD, emphysema, chronic bronchitis, or similar respiratory illness 6. Asthma exacerbation within the last 12 months (course of steroids, or hospital visit) 7. History of heart failure, pulmonary hypertension, embolism, or other pulmonary heart diseases 8. History of recurrent chest infections 9. Acute infection within the last four weeks 10. Major operation within the past four months 11. History of gastrointestinal drug reaction 12. Use of antibiotics in the past 3 months 13. History or current evidence of gastrointestinal disease e.g. chronic constipation, diarrhoea, irritable bowel syndrome, Crohn’s Disease 14. Milk allergy |
| Date of first enrolment | 01/09/2019 |
| Date of final enrolment | 01/10/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
School of Science and Technology
Clifton Campus
Nottingham
NG11 8NS
United Kingdom
Sunbury-on-Thames
TW16 6QU
United Kingdom
Sponsor information
University/education
50 Shakespeare Street
Nottingham
NG1 4FQ
England
United Kingdom
| Phone | No telephone contact available |
|---|---|
| neil.williams@ntu.ac.uk | |
| Website | http://www.ntu.ac.uk/ |
"ROR" |
https://ror.org/04xyxjd90 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- NTU
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as due to the sensitivity behind the data in a competitive environment, it is felt by the participating rugby union club that the sharing of individual data beyond a manuscript publication would not be appropriate. |
Editorial Notes
16/08/2022: Trial’s existence confirmed by Nottingham Trent University Human Ethics Committee.
