None listed
Conditions
Brief summary
Osteoarthritis (OA) is the most common type of joint disease, contributing to progressive pain and disability in the elderly. In New Zealand, OA is affecting 10.2% of the adult population and the incidence escalating with age, and obesity causing the large health-related quality of life loss in NZ. The prevalence of OA is generally higher in women compared to men, as the incidence tend to consistently increase, particularly following menopause, likely due to losing the protective effect of estrogen on joint tissue. There is no cure for OA and the conventional treatment only used for symptom management. Oil extract from the Greenshell mussel (GSM), a native New Zealand shellfish, has been effective to reduce OA symptoms. A recent animal study showed flash-dried powder from whole GSM meat has preventive effects against the early-stage of metabolic-associated OA. In this study adding GSM powder into the diet of rats actively developing diet-induced OA reduced the cartilage degradation marker. Results from this preliminary study support the potential for an intervention study feeding human subjects with the whole meat GSM powder in order to attenuate the development of OA in a high-risk population. Therefore, this study aims to evaluate the effects of flash-dried whole meat GSM powder (3 g/day) or identical placebo for 12 weeks on cartilage and bone biomarkers, inflammation, body composition, health parameters, knee function and joint pain in healthy overweight/obese postmenopausal women. Data will be collected using questionnaires to assess the demographic detail, dietary intake, knee function, and pain. Blood (20 ml) and spot urine samples will be collected at the beginning, week 6 and week 12 to measure the biomarkers of cartilage, bone, and inflammation. Dual-energy X-ray absorptiometry (DXA) will be used at the beginning and week 12 for body composition (fat/lean ratio) measurement.
Interventions
6 capsules daily, each containing 0.5 gram of flash-dried powder from whole green shell mussel meat (a total of 3 grams per day) for 12 weeks to be taken orally with meals
Subject diaries will be dispensed to each subject at randomization for subjects to record their capsule intake on each day empty containers will be collected. At the week 6 and 12, the subject will return their unused capsule to researcher to assess the rate of the compliance. At week 6, and 12 consumptions record diaries
6 capsules daily, each containing 0.5 gram of flash-dried powder from whole green shell mussel meat (a total of 3 grams per day) for 12 weeks to be taken orally with meals Subject diaries will be dispensed to each subject at randomization for subjects to record their capsule intake on each day empty containers will be collected. At the week 6 and 12, the subject will return their unused capsule to researcher to assess the rate of the compliance. At week 6, and 12 consumptions record diaries will be cross-checked with subject
Sponsors
National Science Challenge, High Value Nutrition (HVN) “Musseling up: high-value Greenshell Mussel Foods”,
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
55 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy postmenopausal women who are at least five years menopausal (based on the natural cessation of menstruation) Aged 55 to 75 years Having body mass index (BMI) 25-35 kg/m2 With no major illness
Exclusion criteria
-Formal diagnosis of osteoarthritis or rheumatoid arthritis -Formal diagnosis of chronic liver or renal function disease (based on medical history or abnormal liver function and kidney function test at screening) -Formal diagnosis of diabetes mellitus (based on medical history or HbA1c level at screening) -Having atherosclerosis and cardiac function impairment or bleeding disorder or taking anticoagulants and antiplatelets e.g. warfarin ,aspirin -A history of allergy to Mussels or seafood. -History of injury or trauma to joint -Taking supplements for joint health e.g. Green Lipped mussel, Glucosamine, chondroitin, or Collagen and unwilling to stop these 4 weeks before beginning of the trial. -Using vitamins or mineral or omega-3 supplements regularly and unwilling to stop these 4 weeks before beginning of the trial. -Currently consuming more than two units of alcohol per day or currently smoking cigarettes. Currently taking hormone replacement therapy or less than 6 months prior beginning the trial Continuously taking (everyday) anti-inflammatory drugs; glucocorticoids, and NSAID drugs e,g aspirin, ibuprofen, naproxen, diclofenac, Celebrex.
Outcome results
None listed