Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001092482
Ethics application status
Approved
Date submitted
8/08/2016
Date registered
12/08/2016
Date last updated
19/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gelatin supplementation around exercise and type 1 collagen synthesis
Scientific title
Vitamin C-enriched gelatin supplementation prior to intermittent activity in healthy active males augments collagen synthesis
Secondary ID [1] 289885 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Collagen Synthesis 299831 0
Condition category
Condition code
Musculoskeletal 299750 299750 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy male subjects will complete a randomized double-blinded cross-over design. Subjects will randomly consume either 5, or 15 grams of gelatin or an isocaloric placebo control. Subjects will consume each treatment orally mixing the treatment from an opaque sachet in a Vitamin C enriched (48mg) flavoured beverage (400ml). Subjects will be instructed to mix the beverage in a opaque bottle and consume as quickly as possible. Each treatment will be consumed 1 hour prior to the completion of 6 minutes of self paced skipping. Subjects will complete each treatment of the investigation and have a 4 day wash out period between crossing over to an alternate treatment.
In Lab acute ingestion and exercise phase
At baseline and 1 hour after the ingestion of the initial treatment (single dose prior to skipping) a large blood sample (50ml) will be taken, Sterile serum from these blood samples will be used for the treatment of engineered ligaments. Measurements of collagen content and mechanical properties of the engineered ligaments will be undertaken. Blood samples will be taken at 0, 30min, 1, 1.5, 2 and 3hours post ingestion of each treatment for the analysis of serum amino acids concentrations. Four hours post exercise a final blood sample will be collected for post exercise serum amino-terminal propeptide of collagen I (PINP) analysis before the subject will be allowed to leave the lab.

Supplementation and exercise phase
Immediately following the above acute ingestion investigation phase subject will be required to repeat the intervention (treatment ingestion 1 hour prior to 6 minutes of self paced rope-skipping) 3 times a day with at least 6 hours between exercise bouts for 3 days. Subjects will return to the lab at 24, 48, and 72 hours post initial exercise and ingestion of treatment for determination of serum PINP concentrations. Subjects adherence to treatment ingestion and exercise will be completed at daily blood collection time points through verbal feedback and recorded by the researcher. As above subjects will have a 4 day wash out period before crossing over to on of the other randomly assigned treatments.
Intervention code [1] 295559 0
Treatment: Other
Comparator / control treatment
Gelatin ingestion of 5 and 15g will be compared to placebo control group of 15g of isocaloric maltodextrin. All treatments will be consumed in a vitamin-c enriched (48mg) beverage (400ml)
All subjects will complete identical exercise protocols with the only difference being the amount of gelatin consumed
Control group
Placebo

Outcomes
Primary outcome [1] 299204 0
Change in engineered ligament collagen content and mechanics. Engineered ligaments will be grown in serum taken a each time point for each treatment
Timepoint [1] 299204 0
Baseline and 1 hour post ingestion of treatment. This is assessed in arm 1 only.
Primary outcome [2] 299205 0
Change in serum amino-terminal propeptide of collagen I (PINP) content over time in response to treatment and exercise
Timepoint [2] 299205 0
Pre treatment ingestion (baseline), 4, 24, 48, and 72 hours. This outcome is assessed in arm 2 only
Secondary outcome [1] 326501 0
Change in serum amino acid availability after the ingestion of the treatment
Timepoint [1] 326501 0
Pre treatment (basleline), 30 minutes, 1, 1.5, 2 and 3 hours post ingestion of treatment. This outcome is in relation to arm 1.

Eligibility
Key inclusion criteria
Active individuals exercising 2-3x per week.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of recurrent connective tissue, tendon or ligament injury or current injury which prevents the exercise task being completed.
Known allergy to animal gelatin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be controlled by a central researcher.
Subjects will receive numerically identified treatments in sealed opaque envelops and told to mix treatments in opaque bottles stirring and consuming treatments as quickly as possible.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations
Arm 1
To detect a 2.4 ug change in engineered ligament collagen content assuming a SD of 1ug with 80% power at the 0.05 level a required sample size of 8 subjects was estimated.
Arm 2
To detect a 25 ng/mL change in the pre-post treatment serum PINP assuming a SD of the difference of 13 ng/mL with 80% power at the 0.05 level, a required sample size of 8 subjects was estimated.

Statistical analysis
Amino acid content and PINP levels will be analyzed by two-way analysis of variance with one factor being time and the other being gelatin in the supplement.
Post-hoc test using Tukey's multiple comparisons test will be utilised to determine the effect of the treatments.
Engineered ligament data will be analyzed by one-way ANOVA with Tukey’s post hoc for the different gelatin levels in the supplement.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/07/2015
Date of last participant enrolment
Anticipated
Actual
5/10/2015
Date of last data collection
Anticipated
18/09/2015
Actual
23/10/2015
Sample size
Target
8
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 294249 0
Government body
Name [1] 294249 0
National Institute on Aging
Country [1] 294249 0
United States of America
Funding source category [2] 294250 0
University
Name [2] 294250 0
University of California Davis
Country [2] 294250 0
United States of America
Funding source category [3] 294251 0
Government body
Name [3] 294251 0
Australian Institute of Sport - Nutrition
Country [3] 294251 0
Australia
Primary sponsor type
Government body
Name
Australian Institute of Sport
Address
AIS Nutrition
Building 19
Leverrier St
Bruce, 2616, Canberra, ACT.
Country
Australia
Secondary sponsor category [1] 293082 0
None
Name [1] 293082 0
Address [1] 293082 0
Country [1] 293082 0
Other collaborator category [1] 279151 0
University
Name [1] 279151 0
University of California Davis
Address [1] 279151 0
Hutchison Dr,
Davis, CA 95616, United States
Country [1] 279151 0
United States of America
Other collaborator category [2] 279152 0
University
Name [2] 279152 0
Monash University
Address [2] 279152 0
Centre of Cardiovascular Research & Education in Therapeutics, School of Public Health and Preventive Medicine,
Wellington Rd & Blackburn Rd, Clayton VIC 3800
Country [2] 279152 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295673 0
Australian Institute of Sport Ethics Comittee
Ethics committee address [1] 295673 0
Ethics committee country [1] 295673 0
Australia
Date submitted for ethics approval [1] 295673 0
17/03/2015
Approval date [1] 295673 0
14/04/2015
Ethics approval number [1] 295673 0
20150401

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

Contacts
Principal investigator
Name 68098 0
Mr Gregory Shaw
Address 68098 0
Australian Institute of Sport
Sport Nutrition
PO Box 176
Belconnen, 2617, ACT,
Country 68098 0
Australia
Phone 68098 0
+61 412881541
Fax 68098 0
Email 68098 0
[email protected]
Contact person for public queries
Name 68099 0
Gregory Shaw
Address 68099 0
Australian Institute of Sport
Sport Nutrition
PO Box 176
Belconnen, 2617, ACT,
Country 68099 0
Australia
Phone 68099 0
+61 412881541
Fax 68099 0
Email 68099 0
[email protected]
Contact person for scientific queries
Name 68100 0
Gregory Shaw
Address 68100 0
Australian Institute of Sport
Sport Nutrition
PO Box 176
Belconnen, 2617, ACT,
Country 68100 0
Australia
Phone 68100 0
+61412881541
Fax 68100 0
Email 68100 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
SourceTitleYear of PublicationDOI
EmbaseVitamin C-enriched gelatin supplementation before intermittent activity augments collagen synthesis.2017https://dx.doi.org/10.3945/ajcn.116.138594
EmbaseEffects of different Vitamin C-enriched collagen derivatives on collagen synthesis.2019https://dx.doi.org/10.1123/ijsnem.2018-0385
N.B. These documents automatically identified may not have been verified by the study sponsor.