Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000771954
Ethics application status
Approved
Date submitted
17/11/2008
Date registered
22/07/2011
Date last updated
22/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutrition supplementation and immunity in athletes
Scientific title
Effects of butyrylated high amylose maize starch compared to low amylose maize starch on faecal microbiology and immunity in athletes.
Secondary ID [1] 262422 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal illness 3988 0
Upper respiratory tract illness 268387 0
Condition category
Condition code
Alternative and Complementary Medicine 4187 4187 0 0
Other alternative and complementary medicine
Inflammatory and Immune System 268527 268527 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To examine the effect of butyrylated high amylose maize starch on immune and microbiological parameters in 40 well trained athletes in a double blind placebo controlled parallel trial over 28 days. Butyrylated high amylose maize starch is non-digestible starch that promotes the growth of beneficial microbes in the gastrointestinal tract. In this case the starch has had butyric acid incorporated into its structure. Butyric acid is the primary fuel for colonocytes and promotes normal functioning of these cells. The supplement is in a powder form and will be mixed and consumed with a protein drink (musashi protein powder) twice daily for 28 days. A total of 40 grams per day of the butyrylated high amylose maize starch will be consumed per day. The expected outcomes are an increase in faecal short chain fatty acids (butyrate, acetate and propionate), an increase in total faecal bacteria and increases in salivary antimicrobial proteins and serum cytokines.
Intervention code [1] 3710 0
Lifestyle
Intervention code [2] 266795 0
Prevention
Comparator / control treatment
The control is low amylose maize starch. Using low amylose maize starch as a control ensures that participants allocated to the control group receive the same amount of resistant starch as the intervention group. The low amylose maize starch is a powder that will be incorporated into a protein drink (musashi). 40 grams per day will be consumed for 28 days.
Control group
Active

Outcomes
Primary outcome [1] 5076 0
Faecal short chain fatty acids (butyrate, acetate and propionate) were determined by gas liquid chromatography
Timepoint [1] 5076 0
Day 0, day 12 (mid-study) and day 28
Primary outcome [2] 268980 0
Serum cytokines including interleukin (IL) 1RA, 6, 8, 10, granulocyte colony stimulating factor, interferon gamma, tumor necrosis factor alpha. All cytokines are measured by microarray
Timepoint [2] 268980 0
Day 0 (baseline), day 12 (mid-study) and day 28.
Primary outcome [3] 268981 0
Quantitation of total faecal bacteria by microarray and quantitative polymerase chain reaction.
Timepoint [3] 268981 0
Day 0 (baseline), day 12 (mid-study) and day 28.
Secondary outcome [1] 8528 0
Gastrointestinal and upper respiratory symptoms will be determined by the self reported questionnaire. Symptoms of gastrointestinal illness include flatulance, stomach rumbles, diarrhoea, bloating. Symptoms of respiratory illness include scratchy throat, sore throat, coughing, sneezing, runny nose, blocked nose and headache. An episode will include two or more symptoms for 3 or more days.
Timepoint [1] 8528 0
Daily throughout the course of supplementation
Secondary outcome [2] 279261 0
Salivary antimicrobial proteins and antibodies including immunoglobulin A (SIgA), lactoferrin (Lf) and lysozyme (Ly). All salivary measures will be analysed by commercial enzyme linked immunoassay (SIgA - Stratech Scientific, Lf- Calbiochem and Ly - Saphhire Bioscience)
Timepoint [2] 279261 0
Day 0, day 12 (mid-study) and day 28

Eligibility
Key inclusion criteria
Normal biochemistry and haematology, athletic training background of 3 years, a minimal maximal oxygen uptake (VO2max) of 45 ml/kg/min for women and 50 ml/kg/min for men, no use of immunomodulatory medicines.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No history of irritable bowel syndrome/disease, crohn's disease, autoimmune conditions.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects were recruited from the local cycling community in the ACT. Subjects were pair matched on maximal oxygen uptake and allocated by an independent statistician off-site using a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random computer generated numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4110 0
2600
Recruitment postcode(s) [2] 4111 0
2601
Recruitment postcode(s) [3] 4112 0
2602
Recruitment postcode(s) [4] 4113 0
2914
Recruitment postcode(s) [5] 4114 0
2614
Recruitment postcode(s) [6] 4115 0
2906
Recruitment postcode(s) [7] 4116 0
2617
Recruitment postcode(s) [8] 4117 0
2616
Recruitment postcode(s) [9] 4118 0
2905

Funding & Sponsors
Funding source category [1] 4178 0
Government body
Name [1] 4178 0
Commonwealth Scientific and Industrial Research Organisation
Country [1] 4178 0
Australia
Primary sponsor type
Government body
Name
Australian Institute of Sport
Address
C/- Nicholas West
Department of Physiology
Australian Institute of Sport
PO BOx 176
Belconnen ACT 2617
Country
Australia
Secondary sponsor category [1] 3750 0
None
Name [1] 3750 0
Address [1] 3750 0
Country [1] 3750 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study will investigate 28 days of butyrylated resistant starch supplementation on faecal short chain fatty acids, faecal microbiology and immunity in well trained athletes. Well trained athletes undertaking prolonged endurance exercise suffer gastrointestinal dysfunction and suppression of immunity from heavy exercise training. This supplement is being investigated to examine whether it may reverse these issues.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29137 0
Address 29137 0
Country 29137 0
Phone 29137 0
Fax 29137 0
Email 29137 0
Contact person for public queries
Name 12294 0
Mr Nicholas West
Address 12294 0
C/- Nicholas West
Department of Physiology
Australian Institute of Sport
PO BOx 176
Belconnen ACT 2617
Country 12294 0
Australia
Phone 12294 0
+6126214 7340
Fax 12294 0
Email 12294 0
Nicholas.west@ausport.gov.au
Contact person for scientific queries
Name 3222 0
Mr Nicholas West
Address 3222 0
C/- Nicholas West
Department of Physiology
Australian Institute of Sport
PO BOx 176
Belconnen ACT 2617
Country 3222 0
Australia
Phone 3222 0
+6126214 7340
Fax 3222 0
Email 3222 0
Nicholas.west@ausport.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.