RecruitingACTRN12622000980730

Effects of an omega-3 rich food on markers of inflammation in people with Achilles tendinopathy.


Sponsor

University of Auckland

Enrollment

60 participants

Start Date

Dec 16, 2022

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Achilles tendinopathy is a painful condition of the tendon that connects the calf muscles to the heel bone, often causing stiffness and aching that makes walking and exercise difficult. Chronic inflammation plays a key role in why the tendon struggles to heal properly. Omega-3 fatty acids — found in fish oil and certain algal oils — are well known to reduce inflammation throughout the body, but their specific effect on tendon healing has not been well studied in a clinical trial. This study recruits people with Achilles tendinopathy from physiotherapy clinics in Auckland and randomly assigns them to either a food product containing omega-3 (from algal and NZ Hoki fish oil) or a placebo product containing vegetable oil with no omega-3. Participants eat 9 grams of their assigned product daily for 12 weeks. Blood tests for inflammatory markers, ultrasound scans of the tendon, and questionnaires about pain and wellbeing are completed at the start, at 6 weeks, and at 12 weeks. You may be eligible if you have been diagnosed with Achilles tendinopathy by a physiotherapist and have had symptoms for more than four weeks. You would not be eligible if you currently take omega-3 supplements or anti-inflammatory drugs (NSAIDs), have had injections for the condition, have an autoimmune disease, or have a BMI above 30.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 treatme

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.


Locations(1)

Auckland, New Zealand

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