Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000354583p
Ethics application status
Submitted, not yet approved
Date submitted
27/02/2024
Date registered
27/03/2024
Date last updated
27/03/2024
Date data sharing statement initially provided
27/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Collagen Digestion Study: An investigation of products of digestion following consumption of Collagen Hydrolysate in women over 50
Scientific title
Investigation of products of digestion following consumption of Collagen Hydrolysate in healthy women over 50
Secondary ID [1] 311580 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12622000779774p

Health condition
Health condition(s) or problem(s) studied:
Joint health 332959 0
Osteoarthritis 332960 0
Inflammation 332961 0
Condition category
Condition code
Musculoskeletal 329673 329673 0 0
Osteoarthritis
Metabolic and Endocrine 329674 329674 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fasted participants will attend one visit to the Human Nutrition Research Unit at Massey University. After arrival at the research unit they will have 10mL venous blood drawn to determine baseline. The participant will then consume a drink of 15g collagen protein suspended in 200mL water. Two hours later, a second blood sample of 10mL will be collected. Blood samples will be drawn by a trained and experienced phlebotomist and participants monitored throughout their visit by one of the research team. Adherence will be determined by consumption of the full 200mL drink.
Intervention code [1] 328033 0
Treatment: Other
Comparator / control treatment
Participants will act as their own comparator with a baseline blood sample.
Control group
Active

Outcomes
Primary outcome [1] 337457 0
Absorption of the collagen supplement will be assessed through measurement of di- and tri-peptides in the blood.
Timepoint [1] 337457 0
Baseline (0 hours) and 2 hours after ingestion of the collagen drink.
Secondary outcome [1] 431949 0
Nil
Timepoint [1] 431949 0
Nil

Eligibility
Key inclusion criteria
Healthy women over 50 years old
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
BMI>26m/kg2, vegan/vegetarian (unwilling to consume gelatin or collagen), known osteoarthritis or probable OA-related pain in knee, hip etc., known connective tissue disorder (e.g., Rheumatoid arthritis, Scleroderma, Lupus, Polymyositis, Marfan’s Syndrome, Ehlers Danlos Syndrome).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/04/2024
Actual
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 26157 0
New Zealand
State/province [1] 26157 0
Manawatu
Country [2] 26158 0
New Zealand
State/province [2] 26158 0
Horowhenua

Funding & Sponsors
Funding source category [1] 315882 0
Government body
Name [1] 315882 0
National Science Challenge High Value Nutrition
Country [1] 315882 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Country
New Zealand
Secondary sponsor category [1] 318025 0
Commercial sector/Industry
Name [1] 318025 0
Southern Pastures Investments
Address [1] 318025 0
Country [1] 318025 0
New Zealand
Secondary sponsor category [2] 318027 0
Commercial sector/Industry
Name [2] 318027 0
Ovation Ltd
Address [2] 318027 0
Country [2] 318027 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314728 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 314728 0
Ethics committee country [1] 314728 0
New Zealand
Date submitted for ethics approval [1] 314728 0
11/03/2024
Approval date [1] 314728 0
Ethics approval number [1] 314728 0

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

Contacts
Principal investigator
Name 132542 0
Dr Katie Schraders
Address 132542 0
Private Bag 11222, School of Food and Advanced Technology, Massey University, Palmerston North, 4442
Country 132542 0
New Zealand
Phone 132542 0
+64 6 951 6228
Fax 132542 0
Email 132542 0
[email protected]
Contact person for public queries
Name 132543 0
Katie Schraders
Address 132543 0
Private Bag 11222, School of Food and Advanced Technology, Massey University, Palmerston North, 4442
Country 132543 0
New Zealand
Phone 132543 0
+64 6 951 6228
Fax 132543 0
Email 132543 0
[email protected]
Contact person for scientific queries
Name 132544 0
Katie Schraders
Address 132544 0
Private Bag 11222, School of Food and Advanced Technology, Massey University, Palmerston North, 4442
Country 132544 0
New Zealand
Phone 132544 0
+64 6 951 6228
Fax 132544 0
Email 132544 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For ethical reasons no individual data will be reported. Data will be presented as group means and standard deviations.


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.