Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000168651
Ethics application status
Approved
Date submitted
11/08/2005
Date registered
17/08/2005
Date last updated
17/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Post-exercise Nutrition Recovery and Immune Response Study
Scientific title
An investgation of the blood glucose and insulin responses and changes in immune function markers of elite rowers after consuming recovery beverages with differing glycaemic indices and protein content after a two-hour endurance training session.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood glucose and insulin and immune responses. 263 0
Condition category
Condition code
Blood 295 295 0 0
Normal development and function of platelets and erythrocytes
Inflammatory and Immune System 296 296 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After consuming a standardised snack, participants will complete their usual 2 hour endurance based training session. After training each participant will consume one of 4 different beverages on 4 separate occasions in random order. Blood glucose and insulin reponses to each beverage will be monitored. At 2 time points post-conumption blood samples will be drawn to measure immune function.
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 348 0
Blood glucose and insulin and immune responses to each beverage.
Timepoint [1] 348 0
Secondary outcome [1] 787 0
Feelings of satiety and recovery to each beverage.
Timepoint [1] 787 0

Eligibility
Key inclusion criteria
Healthy elite rowers underatking mulitple workouts on the same day and continous through out the week.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of diabetes mellitus.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment outside Australia
Country [1] 136 0
New Zealand
State/province [1] 136 0

Funding & Sponsors
Funding source category [1] 354 0
Other
Name [1] 354 0
Country [1] 354 0
Primary sponsor type
Individual
Name
Dr Tracy Perry
Address
Country
Secondary sponsor category [1] 280 0
None
Name [1] 280 0
nil
Address [1] 280 0
Country [1] 280 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36094 0
Address 36094 0
Country 36094 0
Phone 36094 0
Fax 36094 0
Email 36094 0
Contact person for public queries
Name 9355 0
Sara Macdonald
Address 9355 0
C/- Department of Human Nutrition
University of Otago
PO Box 56
Union St
Dunedin 9007
Country 9355 0
New Zealand
Phone 9355 0
+64 3 4797940
Fax 9355 0
Email 9355 0
[email protected]
Contact person for scientific queries
Name 283 0
Dr Tracy Perry
Address 283 0
C/- Department of Human Nutrition
University of Otago
PO Box 56
Union St
Dunedin 9007
Country 283 0
New Zealand
Phone 283 0
+64 3 4797508
Fax 283 0
Email 283 0
[email protected]

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.