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| Name | Class |
|---|---|
| DSM-Firmenich AG | UNKNOWN |
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This is a randomised, double-blind, parallel, placebo-controlled study in healthy adults to compare the absorption of two microalgal formulations, to a fish oil and a placebo. Participant will take their assigned study product for 6 weeks and attend the clinic for 4 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| life'sTM Omega O1035DS nTG | Experimental | life'sTM Omega O1035DS is a nTG derived from microalgae with minimum 365 mg DHA, minimum 100 mg EPA, and minimum 520 mg/g DHA + EPA. All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks. |
|
| life'sTM Omega O3020DS nTG | Experimental | life'sTM Omega O3020DS is a nTG derived from microalgae with minimum 210 mg DHA, minimum 300 mg EPA, and minimum 510 mg/g DHA + EPA. All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks. |
|
| MEG-3TM 3223 rTG | Active Comparator | The fish oil will be MEG-3TM 3223 rTG with minimum 230 mg DHA, minimum 320 mg EPA, and minimum 640 mg/g Omega-3. All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks. |
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| Placebo | Placebo Comparator | The placebo capsules will be a mixture of corn and soybean oils. 515 mg corn oil and 515 mg soybean oil. Each subject will consume three capsules for a day for 6 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| life'sTM omega O1035DS nTG | Dietary Supplement | All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 6 between MEG-3 3223, O1035DS nTG and O3020DS nTG and placebo | The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 6 between MEG-3 3223, O1035DS nTG and O3020DS nTG and placebo as determined by Gas Chromatography (GC). | Baseline to week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the bioavailability of Omega-3 fatty acids after the supplementation of O1035DS nTG, O3020DS nTG, MEG-3 3223rTG to placebo by comparing the changes from baseline in the sum level of plasma phospholipids at 2, 4 and 6 weeks of supplementation. | The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 2, 4, and 6 between MEG-3 3223 rTG, O1035DS nTG, O3020DS nTG and placebo as determined by Gas Chromatography (GC). |
| Measure | Description | Time Frame |
|---|---|---|
| Additional 1: Change from baseline in plasma phospholipid EPA at weeks 2, 4 and 6 across the groups adjusted for intake level | Change from baseline in plasma phospholipid EPA at weeks 2, 4 and 6 in MEG-3 3223, O3020DS nTG, O1035DS nTG and placebo adjusted for intake level. | Baseline, week 2, week 4, week 6 |
| Additional 2: Change from baseline in plasma phospholipid DHA at weeks 2, 4 and 6 across the treatment groups adjusted for intake level. |
Inclusion Criteria:
Written informed consent obtained before any trial related assessments are performed.
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).
v. Contraceptives must be effective before the randomization visit.
3. Participant's body mass index (BMI) must be between 18 and 32 kg/m2 (inclusive), and considered to be of healthy weight in the opinion of the investigator.
Intakes of EPA+DHA of <300 mg per day based on the FFQ
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 | Fortitude Valley | Queensland | 4006 | Australia |
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| Label | URL |
|---|---|
| Study also registered on ISRCTN registry | View source |
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Randomized, double-blind, placebo-controlled, parallel assignment
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| life'sTM omega O3020DS nTG | Dietary Supplement | All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day. |
|
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| MEG-3 3323rTG | Dietary Supplement | All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day. |
|
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| Placebo | Other | The placebo capsules will be a mixture of corn and soybean oils. 515 mg corn oil and 515 mg soybean oil. Each subject will consume three capsules a day. |
|
| Baseline, week 2, week 4, week 6 |
| To compare the bioavailability of Omega-3 fatty acids (EPA+DHA) from MEG-3 3223, O1035DS nTG, O3020DS nTG to placebo by comparing the change from baseline in the Omega-3 Index at the end of 6 weeks supplementation. | The change in the Omega-3 Index from baseline to week 6 between MEG-3 3223, O1035DS nTG, O3020DS nTG and placebo as determined by Gas Chromatography (GC). | Baseline to week 6 |
| To assess the bioavailability of Omega-3 fatty acids after the supplementation of MEG-3 3223, O1035DS nTG, O3020DS nTG and placebo by comparing the changes in the sum level of plasma phospholipids from baseline at 2 and 4 weeks of supplementation. | The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 2 and 4 after supplementation of MEG-3 3223, O1035DS nTG, O3020DS nTG and placebo as determined by Gas Chromatography (GC). | Baseline, week 2, week 4 |
| To compare changes from baseline in lipoprotein levels (total cholesterol, HDL- and LDL-cholesterol and triglyceride levels) after supplementation of MEG-3 3223, O1035DS nTG, O3020DS nTG and placebo at the end of a 6-week study. | The change in total cholesterol, HDL- and LDL-cholesterol and triglyceride levels from baseline to week 6 between MEG-3 3223, O1035DS nTG, O3020DS nTG and placebo as determined by a clinical analyser. | Baseline, week 6 |
Change from baseline in plasma phospholipid DHA at weeks 2, 4 and 6 in MEG-3 3223, O3020DS nTG, O1035DS nTG and placebo adjusted for intake level. |
| Baseline, week 2, week 4, week 6 |
| Additional 3: Cytokines/Inflammatory markers | Exploratory parameters [e.g., Cytokines and inflammatory markers (e.g., TNF-alpha, IL-1alpha, IL1beta, IL-6, IL-10, hs-CRP, HbA1c) will be assessed at baseline and week 6.](streamdown:incomplete-link) | Baseline, week 6 |
| Additional 3: Neurotransmitters | Exploratory parameters: neurotransmitters (e.g., GABA, BDNF, serotonin, cortisol) will be assessed at baseline and week 6., | Baseline, week 6 |
| Additional 3: Oxylipins | Exploratory parameters: oxylipins (e.g. resolvins, maresins, protectins) will be assessed at baseline and week 6. | Baseline, week 6 |
| Additional 3: PhenoAgeAccel 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, week 6 |
| Additional 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, week 6 |
| Additional 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, week 6 |
| Additional 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, week 6 |
| Safety Endpoint 1: Clinical Chemistry | Screening and final visit clinical chemistry profiles will be assessed from a blood sample by a clinical analyser. Tests included in the clinical chemistry profile include sodium, potassium, chloride, bicarbonate, anion gap, calcium (corrected), phosphate, urea, urate, creatinine, eGFR, glucose, total protein, albumin, globulins, total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), GGT, lactate dehydrogenase, iron studies, creatine kinase, magnesium, cholesterol, triglycerides, HDL and LDL. | Screening, week 6 |
| Safety Endpoint 1: Haematology | Screening and final visit haematology profiles will be assessed from a blood sample by a clinical analyser. Tests included in the haematology profile are haemoglobin, MCV, RCC, haematocrit, MCH, MCHC, RDW%, reticulocytes, ESR, platelets, white cell count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. | Screening, week 6 |
| Safety Endpoint 2: BP | Vital signs: Blood pressure (BP) will be assessed at screening/baseline and final visit. | Screening, baseline and week 6 |
| Safety Endpoint 2: HR | Vital signs: Heart rate (HR) will be assessed at screening/baseline and final visit. | Screening, baseline, week 6 |
| Safety Endpoint 2: Body temperature | Vital signs: Body temperature will be assessed at screening/baseline and final visit. | Screening, baseline, week 6 |
| Safety Endpoint 3: Weight | Anthropometric: Weight (kg) will be assessed at screening, baseline and the final visit. | Screening, baseline, week 6 |
| Safety Endpoint 3: WHR | Anthropometric: Waist-hip-ratio (WHR) will be assessed at baseline and the final visit. | Baseline, week 6 |
| Safety Endpoint 4: AEs | Adverse event (AE) listing will be collected. | Screening to week 6 |
| Safety Endpoint 5: SAEs | SAEs will be collected and reported. | Baseline to week 6 |
| ID | Term |
|---|---|
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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