Krill and Greenshell Mussel (GSM) on joint health and osteoarthritis
Effect of a combined Krill and Greenshell Mussel (GSM) supplement on joint health and osteoarthritis in an older adult population: A double-blind randomized placebo-controlled parallel study.
RDC Global Pty Ltd
80 participants
Nov 6, 2020
Interventional
Conditions
Summary
Effect of a combined Krill and Greenshell Mussel (GSM) supplement on joint health and osteoarthritis in an older adult population: A double-blind randomized placebo-controlled parallel study. The aim of this study is to assess the effectiveness of a phospholipid and omega-3 (from krill and GSM) supplement on joint health and osteoarthritis compared to a placebo (glycerol). We will test the hypothesis that supplementation with omega-3 will enhance joint health and quality of life in older adults.
Eligibility
Inclusion Criteria7
- Males and females aged over 45 years old inclusive
- Diagnosed with osteoarthritis
- Reporting joint pain (not associated with acute injury, long-standing disease or prescription medication use)
- Otherwise healthy, BMI 18.5-34.9 kg/m2
- Able to provide informed consent
- Agree not to change current diet and exercise program
- Access to internet
Exclusion Criteria14
- Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland function malignancy)*
- Malignancy (current) or treatment (chemotherapy and radiotherapy) for malignancy within the previous 2 years
- Clinically significant acute or chronic inflammation, or connective tissue disease including, but not limited to rheumatoid arthritis, bursitis or gout.
- Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy
- Receiving treatment or taking supplements for joint pain/health such as glucosamine and omega-3 containing products#.
- Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse
- Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- Allergic to seafood or any of the ingredients in the active or placebo formula
- Known pregnant or lactating woman
- Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- Participants who have participated in any other related clinical study during the past 1 month
- History of infection in the month prior to the study
- An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
- #Potential participants that are taking supplements that would result in their exclusion must wait a 4-week washout period prior to commencing the study.
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Interventions
The intervention for this study is Krill and Greenshell mussel oil (GSM). Participants will be instructed to take 1 capsule in the morning with food, for a total of 500 mg of krill/GSM oil per day for a total of 8 weeks. Each 500 mg capsule will contain 50 mg of GSM Oil and 450 mg of krill oil. Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group or the active intervention group. Height, weight, waist and hip circumferences, blood pressure and questionnaires regarding joint pain, osteoarthritis symptoms, gastrointestinal tolerance and quality of life will be assessed at enrolment. Within the week pre-treatment, participant’s blood will be collected for analysis of pre-treatment inflammatory blood markers. Prior to starting trial product, participants will complete 1 day of pain recording [(Vas) once morning and once at night] online. Following the completion of the pain recording, the participant will start taking the capsules. Participants will be asked to take the allocated product according to the dose prescribed (500 mg daily). In addition, participants will be asked to complete fortnightly questionnaires regarding their joint pain (Vas and WOMAC). Participants will undertake an additional blood test at week 4 and repeat all baseline measures at the completion of the trial (week 8). At both time point visits (week 4 and 8) and as part of the assessment, participants will be asked to provide details regarding any lifestyle changes (diet, exercise, medication) in addition to subjective changes in exercise, performance and any adverse effects (including change mood/quality of life). Participants will be monitored for compliance with the protocol by a combination of telephone and email communications in addition to each scheduled visit.
Locations(1)
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ACTRN12620001154998