Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000980730
Ethics application status
Approved
Date submitted
8/07/2022
Date registered
12/07/2022
Date last updated
2/11/2023
Date data sharing statement initially provided
12/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of an omega-3 rich food on markers of inflammation in people with Achilles tendinopathy.
Scientific title
Effects of an omega-3 rich food on markers of inflammation in people with Achilles tendinopathy.
Secondary ID [1] 307518 0
Nil
Universal Trial Number (UTN)
U1111-1275-6031
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammation 326945 0
Achilles tendinopathy 326946 0
Condition category
Condition code
Musculoskeletal 324133 324133 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 324134 324134 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to treatment or control group.

Participants in each group will receive a food product in the form of a pump which dispenses a citrus flavoured sauce. In the treatment group the food product will contain the active omega-3 ingredient derived from algal and NZ Hoki oil.

Participants will consume 9g of the food product a day for 12 weeks (equivalent to 9 pumps of the dispenser), which will equate to ~2.5g omega-3/serve in the treatment group.

Adherence will be self-reported through weekly emails and phone calls.
Intervention code [1] 323979 0
Treatment: Other
Comparator / control treatment
The comparator will be placebo product that does not contain omega 3.

The placebo product will be made specifcally for use in the clinical trials. For this product, the Algal and Hoki oil will be replaced with a vegetable oil. All other ingredients will remain the same and the taste, texture and appearance will be the same as the main product.
Control group
Placebo

Outcomes
Primary outcome [1] 331946 0
Circulating Il-6 concentration from blood samples
Timepoint [1] 331946 0
Baseline, 6 weeks and 12 weeks (primary endpoint) post-intervention commencement
Secondary outcome [1] 411686 0
Circulating TNF from blood samples
Timepoint [1] 411686 0
Baseline, 6 weeks and 12 weeks post-intervention commencement
Secondary outcome [2] 411687 0
Achilles tendon structure determined by ultrasound imaging, grading tendinopathy and the stage of tendinopathy (i.e. reactive-early dysrepair or late-dysrepair-degenerative) (Matthews et al., Staging achilles tendinopathy using ultrasound imaging: the development and investigation of a new ultrasound imaging criteria based on the continuum model of tendon pathology. BMJ Open Sport & Exercise Medicine 2020).
Timepoint [2] 411687 0
Baseline, 6 and 12 weeks post-intervention commencement
Secondary outcome [3] 411688 0
Self-reported Achilles function and pain as determined by the Victorian Institute Of Sports Assessment – Achilles (VISA-A) questionnaire
Timepoint [3] 411688 0
Baseline, 6 and 12 weeks post-intervention commencement
Secondary outcome [4] 411689 0
Achilles tendon stiffness determined by shearwave elastography.
Timepoint [4] 411689 0
Baseline, 6 and 12 weeks post-intervention commencement
Secondary outcome [5] 411690 0
Wellbeing determined by the World Health Organisation- Five Well-Being Index (WHO-5) questionnaire
Timepoint [5] 411690 0
Baseline, 6 and 12 weeks post-intervention commencement
Secondary outcome [6] 411740 0
Depression, anxiety and stress determined by the Depression, Anxiety and Stress Scale - 21 Items (DASS-21) questionnaire
Timepoint [6] 411740 0
Baseline, 6 and 12 weeks post-intervention commencement
Secondary outcome [7] 411807 0
Circulating IL-1ß from blood samples
Timepoint [7] 411807 0
Baseline, 6 weeks and 12 weeks post-intervention commencement
Secondary outcome [8] 411808 0
Circulating CRP from blood samples
Timepoint [8] 411808 0
Baseline, 6 weeks and 12 weeks post-intervention commencement

Eligibility
Key inclusion criteria
Diagnosed insertional or mid-portion Achilles tendinopathy by trained physiotherapist with symptoms lasting more than four weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently taking omega 3 supplements, currently taking NSAIDs, previous injectable treatments, tendinopathy caused by high impact trauma, BMI >30, auto-immune disease.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/12/2022
Actual
16/12/2022
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
29/02/2024
Actual
Sample size
Target
60
Accrual to date
35
Final
Recruitment outside Australia
Country [1] 24883 0
New Zealand
State/province [1] 24883 0
Auckland

Funding & Sponsors
Funding source category [1] 311799 0
Government body
Name [1] 311799 0
Ministry of Business, Innovation and Employment - High Value Nutrition Science Challenge
Country [1] 311799 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland Mail Centre
Auckland, 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 313270 0
None
Name [1] 313270 0
Address [1] 313270 0
Country [1] 313270 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311243 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 311243 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 311243 0
New Zealand
Date submitted for ethics approval [1] 311243 0
01/07/2022
Approval date [1] 311243 0
28/07/2022
Ethics approval number [1] 311243 0

Summary
Brief summary
Inflammation is fundamental in maintaining health, and in many healing processes. However, unresolved inflammation has severe health consequences. Unresolved inflammation plays a key role in several chronic diseases, such as cardiovascular disease (CVD), auto-immune diseases such as rheumatoid arthritis, and diabetes and other metabolic-related diseases. Thus, the ability to regulate inflammatory processes is fundamental to maintaining wellbeing. Based on this, the concept of therapeutically targeting systemic inflammation to improve health outcomes is a growing and promising area of research, targeted to improve the wellbeing of people with chronic health disorders.

Supplementation with omega-3 has demonstrable effects on lowering biomarkers of inflammation. This trial builds on existing scientific literature demonstrating a role for omega-3 supplementation in improving inflammation.

This is a a randomised, placebo-controlled clinical trial to explore the effects of a novel, omega-3-rich food product on markers of inflammation in people with Achilles tendinopathy. Sixty participants will be recruited from physiotherapy clinics across the Auckland region who are presenting with chronic Achilles tendinopathy. Participants will be randomised into treatment and control groups (30/group), and prior to intervention will have blood samples taken for analysis of circulating inflammatory cytokines to study systemic inflammation, take a self-reported questionnaire of tendinopathy severity and undergo ultrasound with elastography to assess symptoms, structure and function of the Achilles tendon, and take questionnaires related to mood and wellbeing.
Participants in each group will then receive a food product, with the treatment group product containing the active omega-3 ingredient derived from algal and NZ Hoki oil, and the placebo group product containing a vegetable-derived oil that contains no omega-3. Participants will consume 9g of the food product a day for 12 weeks, which will equate to ~2.5g omega-3/serve in the treatment group. After 6 weeks, and at the end of the study (12 weeks), all outcome measures will be re-assessed.

Overall, this trial has the potential to demonstrate a role for omega-3 rich foods in alleviating systemic inflammation, improving musculoskeletal outcomes and improving wellbeing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120430 0
Dr David Musson
Address 120430 0
Private Bag 92019
Auckland Mail Centre
Auckland, 1142
New Zealand
Country 120430 0
New Zealand
Phone 120430 0
+64 99237514
Fax 120430 0
Email 120430 0
d.musson@auckland.ac.nz
Contact person for public queries
Name 120431 0
Dr David Musson
Address 120431 0
Private Bag 92019
Auckland Mail Centre
Auckland, 1142
New Zealand
Country 120431 0
New Zealand
Phone 120431 0
+64 99237514
Fax 120431 0
Email 120431 0
d.musson@auckland.ac.nz
Contact person for scientific queries
Name 120432 0
Dr David Musson
Address 120432 0
Private Bag 92019
Auckland Mail Centre
Auckland, 1142
New Zealand
Country 120432 0
New Zealand
Phone 120432 0
+64 99237514
Fax 120432 0
Email 120432 0
d.musson@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the de-identified individual participant data collected during the trial
When will data be available (start and end dates)?
Immediately following publication until 10 years post study
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (d.musson@auckland.ac.nz)


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.