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This is a randomised, double-blind, parallel, placebo-controlled study in healthy subjects to compare the absorption of two microalgal formulations, to a fish oil and a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| life's Omega 1035DS | Active Comparator |
| |
| life'sTM Omega O3020DS | Active Comparator |
| |
| MEG-3TM 1812 TG | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| life's Omega 1035DS | Dietary Supplement | A natural triglyceride derived from microalgae with minimum 365 mg DHA, minimum 100 mg EPA, and minimum 520 mg/g DHA + EPA. Participants receive 600mg/d of omega-3 fatty acids from the microalgal oil. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the bioavailability of 600 mg/day of Omega-3 fatty acids (EPA+DHA) from two microalgal sources to a fish source by comparing the change from baseline in the sum level of EPA and DHA in plasma phospholipids across all treatments. | The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 6 between MEG-3, O1035DS and O3020DS and placebo as determined by Gas Chromatography (GC). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the bioavailability by 600mg/day of Omega-3 fatty acids by comparing the change from baseline in the sum level of EPA and DHA in plasma phospholipids across all treatments at the end of a 2, 4, and 6 week supplementation study. | The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 2, 4, and 6 between MEG-3, O1035DS, O3020DS and placebo as determined by Gas Chromatography (GC). |
| Measure | Description | Time Frame |
|---|---|---|
| Additional endpoint 1 | Change from baseline in plasma phospholipid EPA at weeks 2, 4 and 6 in MEG-3, O3020DS, 1035DS and placebo adjusted for intake level. | 2, 4 and 6 weeks |
| Additional endpoint 2 | Change from baseline in plasma phospholipid DHA at weeks 2, 4 and 6 in MEG-3, O3020DS, 1035DS and placebo adjusted for intake level. |
Inclusion criteria:
Written informed consent obtained before any trial related assessments are performed.
2. Healthy adult females ages 18-64 who are neither pregnant nor breastfeeding or healthy adult males ages 18-64 at the time of consent.
a. Female participants of child-bearing potential (females who are post-menopausal, i.e., when there has been no menstruation for a minimum of 12 months prior to screening, are considered not to be of child-bearing potential), who are not surgically sterilized, must have a negative pregnancy test at screening and be willing to practice one of the following appropriate contraceptive methods until the last visit: i. Sexual abstinence. ii. Oral contraceptives. iii. Trans dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to product administration).
iv. Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration).
Contraceptives must be effective before the randomization visit.
Participant's body mass index (BMI) must be between 18 and 30 kg/m2 (inclusive) and participant must weigh a minimum of 50 kg (110 lbs)
Intakes of EPA+DHA of less than 200mg per day based on the FFQ
Omega-3 Index less than 4%
Agree not to change current diet and exercise frequency or intensity during entire study period
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Birkett | dsm-firmenich Switzerland AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical | Brisbane | Queensland | 4000 | Australia |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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| Fish Oil | Dietary Supplement | Commercially available fish oil product MEG-3 1812 TG with a minimum 100 mg DHA/capsule, minimum 160 mg EPA/capsule, and minimum 300 mg/g DHA+EPA. Participants receive 600mg/d of omega-3 fatty acids from the fish oil. |
|
| Placebo | Other | The placebo capsules will be a mixture of corn and soybean oils. Participants receive 600mg/d of omega-3 fatty acids from the corn/soy placebo. |
|
| life's Omega O3020DS | Dietary Supplement | A natural triglyceride derived from microalgae with minimum 210 mg DHA, minimum 300 mg EPA, and minimum 510 mg/g DHA + EPA. Participants receive 600mg/d of omega-3 fatty acids from the microalgal oil. |
|
| 2, 4 and 6 weeks |
| To compare the bioavailability of 600mg/day of Omega-3 fatty acids by comparing the change from baseline in Omega-3 Index across all treatments at the end of a 6 week supplementation study. | The change in the Omega-3 Index (percent of EPA + DHA in red blood cell membranes) from baseline to week 6 between MEG-3, O1035DS, O3020DS and placebo as determined by Gas Chromatography (GC). | 6 weeks |
| To compare the bioavailability of 600mg/day Omega-3 fatty acids by comparing the change from baseline in the plasma phospholipid levels across all treatments at week 2 and week 4 of supplementation. | The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 2 and baseline to week 4 between MEG-3, O1035DS, O3020DS and placebo as determined by Gas Chromatography (GC). | 2 and 4 weeks |
| To compare the changes from baseline in lipoprotein levels following consumption of the microalgal oils, fish oil or placebo at the end of a 6-week supplementation study. | The change in total cholesterol, HDL- and LDL-cholesterol and triglyceride levels from baseline to week 6 between MEG-3, O1035DS, O3020DS and placebo as determined by a clinical analyser. | 6 weeks |
| 2, 4 and 6 weeks |
| Additional endpoint 3 - Cytokines | Exploratory parameters (Cytokines) at baseline and week 6 will be analysed using ELISA. | Baseline and 6 weeks |
| Additional endpoint 3 - neurotransmitters | Exploratory parameters (neurotransmitters) at baseline and week 6 will be analysed using ELISA. | Baseline and 6 weeks |
| Additional endpoint 3 - specialized pro-resolving mediators | Exploratory parameters (specialized pro-resolving mediators) at baseline and week 6 will be analysed using ELISA. | Baseline and 6 weeks |
| Additional endpoint 3 - PhenoAge Accel Index | Exploratory parameters (PhenoAge Accel Index) at baseline and week 6. This is a metric calculated from phenotypic and chronological age, albumin, creatinine, alkaline phosphatase, glycated haemoglobin, WBC count, lymphocyte percentage, haemoglobin, red cell distribution width, MCV and, glucose). | Baseline and 6 weeks |
| Additional endpoint 3 - Aging clock (iAge) | Exploratory parameters (Aging Clock) at baseline and week 6. This is a metric calculated from CXCL9, CCL11, CCL3, leptin, IL-1beta, IL-5, IFN-alpha, IFN-gamma, IL-4. | Baseline and 6 weeks |
| Additional endpoint 3 - PhenoAge Clock | Exploratory parameters (PhenoAge Clock) at baseline and week 6. An epigenetic clock comprised of DNA methylation (DNAm) algorithms that combine information from measurements across the genome to quantify variations in biological versus chronological aging. | Baseline and 6 weeks |
| Additional endpoint 3 - Brain Health Score | Exploratory parameters (Brain Health Score) at baseline and week 6. Brain health score derived from plasma proteomic and metabolomic biomarkers . | Baseline and 6 weeks |
| Safety Endpoint 1 | Screening and final visit clinical chemistry (electrolytes and liver function tests) and haematology (full blood counts) profiles will be assessed by clinical analyser. | 6 weeks |
| Safety Endpoint 2 | Vital signs: Blood pressure (BP) will be assessed at screening, baseline and final visit. | 6 weeks |
| Safety Endpoint 2 | Vital signs: Heart rate (HR) will be assessed at screening and final visit. | 6 weeks |
| Safety Endpoint 2 | Vital signs: Body temperature will be assessed at screening and final visit. | 6 weeks |
| Safety Endpoint 3 | Anthropometric: Weight (kg) will be assessed at screening, baseline and the final visit. | Baseline to 6 weeks |
| Safety Endpoint 3 | Anthropometric: Waist-hip-ratio (WHR) will be assessed at screening and the final visit. | 6 weeks |
| Safety Endpoint 4 | Adverse event (AE) listing will be collected. | 6 weeks |
| Safety Endpoint 5 | Serious Adverse Event (SAE) will be reported to HREC, United BioSource Corporation (UBC) in Geneva, and the sponsor. | 6 weeks |