None listed
Conditions
Brief summary
Marine omega-3 oils have a short shelf life and poor bioavailability due to oxidation. This instability limits their effectiveness and increases manufacturing costs due to the need for softgel encapsulation and stabilising aids. There is a clear industry need for a solution that extends shelf life, improves bioavailability, and enables more versatile product formulations. NETech has developed a proprietary technology that converts marine oils into a stable powder form, significantly reducing oxidation and increasing bioavailability. This technology eliminates the need for additional stabilisers and softgel formats, offering a purer and more versatile omega-3 product compared to existing technologies. This project aims to compare the effect of consuming mussel oil and mussel powder on plasma omega-3 polyunsaturated fatty acid levels.
Interventions
This is a randomised cross-over dietary intervention trial. The intervention will compare Greenshell Mussel (GSM) (Perna canaliculus) oil and GSM salts (powder) on plasma fatty acid levels. Each 5gm supplement will contain around 1.5 grams of omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
Each supplement (5g powder, 5g oil) will be incorporated into a beverage: either juice or a diet soft drink by the study staff. The beverage will be mixed thoroughly and consume
This is a randomised cross-over dietary intervention trial. The intervention will compare Greenshell Mussel (GSM) (Perna canaliculus) oil and GSM salts (powder) on plasma fatty acid levels. Each 5gm supplement will contain around 1.5 grams of omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Each supplement (5g powder, 5g oil) will be incorporated into a beverage: either juice or a diet soft drink by the study staff. The beverage will be mixed thoroughly and consumed immediately by the participant. The supplements will be prepared by the study staff by dissolving the powder and mixed thoroughly in the beverage The intervention will be conducted by a dietitian and a nurse with clinical trial expertise and certification in good clinical practice (nurse). The intervention will be delivered face-to-face at the Clinical Trials Facility at Adelaide University. Twenty participants will attend the clinic on two occasions (over three weeks) each for approximately 9-9 1/2 hours. The visits will be separated by a one-two-week washout period. Participants will attend the clinic each occasion after an overnight fast and weight, height, blood pressure, and heart rate will be measured. A cannula will be inserted into participants forearm for the blood tests. One blood sample will be taken, then participants will consume the dietary supplement they have been randomised to start with (oil or powder). Participants will then consumed a low fat breakfast. Nine samples of blood will be taken at the following times after the first blood draw (time 0) : 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours. Participants will be provided with a comfortable recliner chair, access to TV, magazines as well as snacks, lunch and a frozen meal at the end of their visit. One to two weeks later, participants will return to the clinic to repeat the same process with the other supplement (oil or powder).
Sponsors
Adelaide University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18–70 years at screening 2. Able and willing to provide written informed consent 3. In good general health, as determined by a medical history review 4. Body mass index between 20-35kg/m2 5. Fluent in written and spoken English 6. Have access to a General Practitioner (GP) in Australia during the study period 7. Able and willing to comply with all study requirements, including: • Fasting overnight prior to the clinic visit • Completing clinical assessments • Providing blood samples • Consuming the study supplement as directed
Exclusion criteria
1. Have any chronic medical condition (e.g. CVD, diabetes, high blood pressure or cholesterol) or cancer within the last 2 years 2. Taking blood pressure or cholesterol or related heart medications 3. Have gastrointestinal problems 4. Have an allergy to fish or shellfish or marine products 5. Are a smoker 6. Are pregnant or lactating 7. Have high consumption of any omega-3 fatty acid or other lipid supplements 8. Are participating in any other clinical trial or dietary intervention within 90 days prior to screening or during the study period 9. Have donated blood within 7 days prior to screening, or unwillingness to abstain from blood donation for at least 7 days after the clinic visit 10. Have any other condition or circumstance that, in the opinion of the investigator, may make the participant unsafe for the study
Outcome results
None listed