Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12622000779774
Ethics application status
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Approved
Date submitted
Help: Date submitted
26/05/2022
Date registered
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31/05/2022
Date last updated
Help: Date last updated
18/11/2025
Date data sharing statement initially provided
Help: Data sharing statement date
31/05/2022
Type of registration
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Prospectively registered

Titles & IDs
Public title
Effects of collagen and milk protein on joint comfort and skin appearance in women with knee pain, aged 50 and over.
Scientific title
Effects of bovine collagen hydrolysate and hydrolysed milk protein on joint pain, osteoarthritis symptoms, biomarkers of collagen synthesis/degradation and inflammation and skin elasticity, hydration and dermal thickness in women aged 50 and over with knee pain related to osteoarthritis. A double-blind randomised placebo-controlled parallel study.
Additional trial identifiers [1] 307194 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CHAMP (Collagen Hydrolysate And Milk Protein) Study
Related trial records

Health condition
Health condition(s) studied:
Joint health 326420 0
Osteoarthritis 326421 0
Inflammation 326422 0
Condition category
Condition code
Musculoskeletal 323703 323703 0 0
Osteoarthritis
Metabolic and Endocrine 323704 323704 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants will consume 15g of protein as collagen hydrolysate or milk protein or placebo per day for a total of 17 weeks (4 months). The supplements will be provided as powder in plain vacuum-sealed sachets; the powder will be added to drinks or cereal (normal components of the participant's daily diet). Once enrolled in the trial, participants will be randomly allocated to either one of the two active intervention groups or to the placebo comparator group.
All participants will also be provided with a low-dose multivitamin preparation (daily tablet to be taken concurrently with the supplement) to ensure micronutrients essential for collagen synthesis are not rate-limiting. The multivitamin will contain 100mg ascorbic acid, 5mg iron, 10mg zinc, 2mg manganese and 600[micro]g copper and will be supplied from Blackmores Ltd, Australia.
Participants will be monitored for compliance with the protocol by email or phone communication and a compliance diary (to assess study compliance, nutrient intake and medication use; they will return unused sachets of supplement at the end of the trial.
Intervention code [1] 323643 0
Treatment: Other
Description of the comparator or control
The placebo will be isocaloric maltodextrin powder (19.2g) in identical sachets
Control group
Placebo

Outcomes
Primary outcome [1] 331452 0
Osteoarthritis pain as measured by Knee injury and Osteoarthritis Outcome Score (KOOS) domain for pain
Timepoint [1] 331452 0
Baseline (week 0) and 4, 8, 12 and 17 weeks after starting to take supplement.
Primary outcome [2] 331453 0
Knee injury and Osteoarthritis Outcome Score (KOOS) for the following domains: Symptoms, Activities of Daily Living, Sport & Recreation Function, Quality of Life
Timepoint [2] 331453 0
Baseline (week 0) and 4, 8, 12 and 17 weeks after starting to take supplement.
Primary outcome [3] 331454 0
Biomarker of collagen synthesis: serum/plasma N-propeptide of collagen IIA (PIIANP) as measured by blood test
Timepoint [3] 331454 0
Baseline (week 0) and 17 weeks after starting to take supplement.
Secondary outcome [1] 409942 0
Primary Outcome. Biomarkers of collagen degradation: urinary C-terminal telopeptide of type II collagen (CTX-II) and plasma/serum cartilage oligomeric matrix protein precursor (COMP).
Timepoint [1] 409942 0
Baseline (week 0) and 17 weeks after starting to take supplement.
Secondary outcome [2] 409943 0
Primary Outcome. Skin changes; viscoelasticity, hydration and dermal thickness as assessed by DermaLab Combo.
Timepoint [2] 409943 0
Baseline (week 0) and 17 weeks after starting to take supplement.
Secondary outcome [3] 409946 0
Self-reported change in pain medication use as measured by diary
Timepoint [3] 409946 0
Baseline (week 0) and 4, 8, 12 and 17 weeks after starting to take supplement.
Secondary outcome [4] 409947 0
Inflammatory markers (cytokines IL-1[beta], TNF[alpha]; high-sensitivity C-reactive protein (hsCRP)) as measured by fasting blood test
Timepoint [4] 409947 0
Baseline (week 0) and 17 weeks after starting to take supplement.
Secondary outcome [5] 409948 0
Composite outcome of: Body composition (lean:fat ratio) as assessed by whole-body Dual-energy X-ray absorptiometry (DXA) scan, air displacement plethysomography (BodPod) and bioelectrical impedance analysis (BIA); body mass index (BMI; height assessed by stadiometer, weight assessed by digital scales); waist:hip ratio (assessed by tape measure).
Timepoint [5] 409948 0
Baseline (week 0) and 17 weeks after starting to take supplement.
Secondary outcome [6] 409950 0
Lipid profile (serum total, high-density lipoprotein and low-density lipoprotein cholesterol; triglycerides) as measured by blood test
Timepoint [6] 409950 0
Baseline (week 0) and 17 weeks after starting to take supplement.
Secondary outcome [7] 409951 0
Fasting blood glucose and glycated hemoglobin (HbA1c) as measured by blood test
Timepoint [7] 409951 0
Baseline (week 0) and 17 weeks after starting to take supplement.
Secondary outcome [8] 409952 0
Change in resting blood pressure as measured by Omron automatic blood pressure monitor.
Timepoint [8] 409952 0
Baseline (week 0) and 17 weeks after starting to take supplement.
Secondary outcome [9] 410150 0
Knee function and mobility as measured by Timed Up and Go (TUG) test.
Timepoint [9] 410150 0
Baseline (week 0) and 17 weeks after starting to take supplement.
Secondary outcome [10] 410151 0
Knee function and mobility as measured by 2-minute walk test.
Timepoint [10] 410151 0
Baseline (week 0) and 17 weeks after starting to take supplement.
Secondary outcome [11] 454845 0
Knee function and mobility as measured by 40m-fast paced walk test
Timepoint [11] 454845 0
Baseline (week 0) and 17 weeks after starting to take supplement.
Secondary outcome [12] 454846 0
Knee function and mobility as measured by 30-second chair stand test
Timepoint [12] 454846 0
Baseline (week 0) and 17 weeks after starting to take supplement.
Secondary outcome [13] 454847 0
Knee function and mobility as measured by stair climb test
Timepoint [13] 454847 0
Baseline (week 0) and 17 weeks after starting to take supplement.

Eligibility
Key inclusion criteria
Healthy women aged 50 and over.
BMI 20-40
Presence of self-reported knee pain ("Yes" response to "During the past 6 months, have you had any knee pain for more than half the days in the month?") and KOOS pain score indicating mild osteoarthritis.
Willing to stop taking dietary supplements from 4 weeks before and during trial.
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Healthy volunteers
No
Key exclusion criteria
Vegetarian (unless willing to consume a collagen/gelatine supplement)
Lactose intolerance
Taking medication (other than over the counter pain relief for osteoarthritis or prescribed medication known not to affect outcomes)
Known heart/renal/hepatic disease, rheumatoid arthritis or other autoimmune inflammatory disorders
History of trauma (or surgery) affecting knees within 6 months
Heavy smoker
Heavy alcohol consumer (more than 2 units of alcohol per day)
High weekly intake of meat
Conditions with altered ability to digest and absorb dietary protein (e.g. bariatric surgery)
Already consuming (or consumed within 6 months) oral nutrition supplements containing any amount of chondroitin, glucosamine, or collagen.
Starting hormone replacement therapy (HRT) within 6 months.

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)
The supplements will be presented in sealed, coded, plain packaged sachets.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be assigned to the study groups with a 1:1:1 allocation using a computer-generated blocked randomisation schedule.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated using G*Power software version 3.0.10 and determined that 27 participants will be required for each group at a 90% power and an alpha level of 5%. To allow for attrition over the 119/120-day intervention period, the group size is increased to 33.
If necessary, data will be log transformed to achieve normal distributions and homogeneity of variance. SPSS (version 29, IBM SPSS statistics) will be used for statistical analysis.
Baseline descriptive statistics will be presented as means with standard deviations (overall and by supplement group).
The assumption of normal distribution in variance within groups will be examined through visual inspection of histograms and Q-Q plots before being checked with the Shapiro-Wilk test. Homogeneity of variance between-groups will be checked with Levene’s test.
Post intervention data will be analysed as difference from baseline
Repeated measures will be analysed with linear mixed models (LMM)
Analysis will carried out on the intention to treat basis (ITT). Per-protocol analysis will be performed in the instance of dropouts (i.e. follow up data is unavailable) or the exclusion of participants with adherence to intervention rates <75%.
Adherence will be estimated by counting the number of returned supplement sachets unopened vs opened in relation to the number of days involved in the trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/07/2022
Actual
2/02/2023
Date of last participant enrolment
Anticipated
28/02/2023
Actual
11/10/2023
Date of last data collection
Anticipated
31/07/2023
Actual
5/02/2024
Sample size
Target
100
Accrual to date
Final
82
Recruitment outside Australia
Country [1] 24787 0
New Zealand
State/province [1] 24787 0
Manawatu
Country [2] 24788 0
New Zealand
State/province [2] 24788 0
Horowhenua

Funding & Sponsors
Funding source category [1] 311499 0
Government body
Name [1] 311499 0
National Science Challenge High Value Nutrition
Country [1] 311499 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Private Bag 11-222
Tennant Drive
Palmerston North 4444
Country
New Zealand
Secondary sponsor category [1] 312899 0
Commercial sector/Industry
Name [1] 312899 0
Southern Pastures Investments
Address [1] 312899 0
Baker Tilly Staples Rodway Waikato LP Level 4, BNZ Building 354 Victoria Street Hamilton 3204
Country [1] 312899 0
New Zealand
Secondary sponsor category [2] 312907 0
Commercial sector/Industry
Name [2] 312907 0
Ovation Ltd
Address [2] 312907 0
PO Box 2646 1st Floor, 210 Maraekakaho Hastings 4154
Country [2] 312907 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310959 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310959 0
Ethics committee country [1] 310959 0
New Zealand
Date submitted for ethics approval [1] 310959 0
07/06/2022
Approval date [1] 310959 0
29/08/2022
Ethics approval number [1] 310959 0
NZ HDEC Ref: 2022 exp 12925

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

Contacts
Principal investigator
Name 119502 0
Prof Jane Coad
Address 119502 0
School of Food Technology & Natural Sciences, College of Sciences, Massey University, Palmerston North 4444
Country 119502 0
New Zealand
Phone 119502 0
+64 21970084
Fax 119502 0
Email 119502 0
[email protected]
Contact person for public queries
Name 119503 0
Jane Coad
Address 119503 0
School of Food Technology & Natural Sciences, College of Sciences, Massey University, Palmerston North 4444
Country 119503 0
New Zealand
Phone 119503 0
+64 21970084
Fax 119503 0
Email 119503 0
[email protected]
Contact person for scientific queries
Name 119504 0
Jane Coad
Address 119504 0
School of Food Technology & Natural Sciences, College of Sciences, Massey University, Palmerston North 4444
Country 119504 0
New Zealand
Phone 119504 0
+64 21970084
Fax 119504 0
Email 119504 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No 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.