RDC Clinical
Fortitude Valley, Queensland, 4006, Australia
NCT Number: NCT07241377
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–64 year
All sexes
Interventional
Phase 3
Fortitude Valley, Queensland, 4006, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
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.
Other names: Microalgal oil
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.
Other names: Microalgal oil
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.
Other names: Fish oil
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.
Time frame: Baseline to week 6
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).
Time frame: Baseline, week 2, week 4, week 6
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).
Time frame: Baseline to week 6
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).
Time frame: Baseline, week 2, week 4
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).
Time frame: Baseline, week 6
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.
Time frame: Baseline, week 2, week 4, week 6
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.
Time frame: Baseline, week 2, week 4, 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.
Time frame: Baseline, week 6
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.
Time frame: Baseline, week 6
Exploratory parameters: neurotransmitters (e.g., GABA, BDNF, serotonin, cortisol) will be assessed at baseline and week 6.,
Time frame: Baseline, week 6
Exploratory parameters: oxylipins (e.g. resolvins, maresins, protectins) will be assessed at baseline and week 6.
Time frame: Baseline, week 6
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).
Time frame: Baseline, week 6
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.
Time frame: Baseline, week 6
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.
Time frame: Baseline, week 6
Exploratory parameters (Brain Health Score) at baseline and week 6. Brain health score derived from plasma proteomic and metabolomic biomarkers.
Time frame: Screening, week 6
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.
Time frame: Screening, week 6
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.
Time frame: Screening, baseline and week 6
Vital signs: Blood pressure (BP) will be assessed at screening/baseline and final visit.
Time frame: Screening, baseline, week 6
Vital signs: Heart rate (HR) will be assessed at screening/baseline and final visit.
Time frame: Screening, baseline, week 6
Vital signs: Body temperature will be assessed at screening/baseline and final visit.
Time frame: Screening, baseline, week 6
Anthropometric: Weight (kg) will be assessed at screening, baseline and the final visit.
Time frame: Baseline, week 6
Anthropometric: Waist-hip-ratio (WHR) will be assessed at baseline and the final visit.
Time frame: Screening to week 6
Adverse event (AE) listing will be collected.
Time frame: Baseline to week 6
SAEs will be collected and reported.
RDC Clinical Pty Ltd
Industry
A Randomized, Double-blind Placebo-controlled Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources in Natural Triglyceride Form to One Fish Source in Re-esterified Triglyceride Form (GOBO 2 Study)
Acronym: GOBO 2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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