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HVN1964 Metadata Record - A New Zealand origin, omega-3-rich food for reducing markers of inflammation

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posted on 2023-12-12, 22:59 authored by David MussonDavid Musson

This metadata record and it's attached files make statements about the kinds of data collected as part of this research, and set out policies for governance of that data, now and in the future.

Description: 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.

History

Publisher

University of Auckland

Temporal coverage: start

2022-01-01

HVN Project / Programme Name

HVN1964

Data access requirements

All of the de-identified individual participant data collected during the trial will be available immediately following publication until 10 years post study on a case-by-case basis at the discretion of Primary Sponsor for IPD meta-analyses.

Principal investigator organisation

University of Auckland

Collaborating researchers and affiliations

Principal Investigator: Dr David Mussan, Department of Nutrition and Dietetics, University of Auckland, Auckland Investigators: Associate Professor Andrea Braakhuis (University of Auckland) Associate Professor Richard Ellis (Auckland University of Technology) Dr Dorit Naot (University of Auckland)

Data description

Outcomes of the Study and associated data Primary outcome -Circulating concentrations of Interleukin-6 (IL-6) Associated data: IL-6 concentrations from blood samples Secondary outcomes - Circulating concentrations of Tumour necrosis factor alpha (TNF-α), Interleukin-1 beta (IL-1β), C-reactive protein (CRP) - Achilles tendon structure and severity of tendinopathy determined by ultrasound imaging - Achilles tendon stiffness determined by shear wave elastography - Self-reported Achilles function and pain - Wellbeing - Depression, anxiety, and stress - Activity and sleep data Associated data: TNF-α, IL-1β, and CRP concentrations, ultrasound imaging data, shear wave elastography, Victorian Institute of Sports Assessment – Achilles (VISA-A) questionnaire, World Health Organisation- Five Well-Being Index (WHO-5) questionnaire, Depression, Anxiety and Stress Scale - 21 Items (DASS-21) questionnaire. Daily average number of steps, resting heart rate, sleep data (total time, % deep sleep, light sleep, REM sleep, number of times awake) obtained from activity/ fitness trackers.

Principal investigator contact email

d.musson@auckland.ac.nz

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