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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06629103




Registration number
NCT06629103
Ethics application status
Date submitted
16/09/2024
Date registered
8/10/2024
Date last updated
16/10/2024

Titles & IDs
Public title
A Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA
Scientific title
A Randomized, Double-blind Placebo-controlled Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA from Two Microalgal Sources to One Fish Source
Secondary ID [1] 0 0
2023-5-12-GOBO
Universal Trial Number (UTN)
Trial acronym
GOBO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Optimal Absorption of Omega-3 0 0
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - life's Omega 1035DS
Treatment: Other - Fish Oil
Other interventions - Placebo
Treatment: Other - life's Omega O3020DS

Active comparator: life's Omega 1035DS -

Active comparator: life'sTM Omega O3020DS -

Active comparator: MEG-3TM 1812 TG -

Placebo comparator: Placebo -


Treatment: Other: life's Omega 1035DS
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.

Treatment: Other: Fish Oil
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.

Other interventions: Placebo
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.

Treatment: Other: life's Omega O3020DS
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.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare the bioavailability of 600mg/d of Omega-3 fatty acids by comparing the change from baseline in sum level EPA and DHA in plasma phospholipids across all treatments at the end of 6 weeks supplementation study.
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
2, 4 and 6 weeks
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
2 and 4 weeks
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
6 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Written informed consent obtained before any trial related assessments are performed.
2. 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.
3. 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)
4. Intakes of EPA+DHA of less than 200mg per day based on the FFQ
5. Omega-3 Index less than 4%
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:

1. Participant has any health conditions that would prevent from fulfilling the study requirements, put the participant at risk or would confound the interpretation of the study results as judged by the Investigator on medical history and routine laboratory test results.
2. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the participant or the validity of the study results.

1. More specifically, history or presence of diabetes, high triglycerides (greater than 150 mg/dL), or high cholesterol (greater than 200 mg/dL).
2. Has a clinically significant abnormal finding on the medical assessment, medical history, vital signs or clinical laboratory results at screening.
3. History or presence of allergic or adverse response to omega-3-acid ethyl esters or triglycerides (EPA or DHA), or related drugs, or sensitivity or allergy to fish or shellfish.
4. History of coagulation disorder or current anticoagulation therapy.
5. Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
6. Has participated in another clinical trial (randomised participants only) within 30 days prior to the first dose of study medication.
7. Has used any over the counter (OTC) medication within 7 days prior to the first dose of study medication. (except for occasional Ibuprofen and Paracetamol use)
8. Has used omega-3 supplements, fish oil, krill oil, or flaxseed within 2 months prior to the first dose of study medication.
9. Has consumed canola oil, walnuts, or any product supplemented with omega-3 fatty acids (e.g., orange juice) or fatty fish more than 2x/week within 14 days prior to the first dose of study medication.
10. Has used any prescription medication within 4 weeks of the screening visit; except hormonal contraceptive, hormonal replacement therapy, or occasional use of ibuprofen or paracetamol.
11. Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
12. History of substance abuse or treatment (including alcohol) within the past 2 years.
13. Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
14. Has increased bleeding from existing pathological conditions or anticipates surgery prior to, throughout, or within 1 week after study participation.
15. Has any dental appointment scheduled throughout or within 1 week after study participation.
16. Has had a transient ischemic attack (TIA) or stroke or is at high risk for recurrent ischemic events.
17. Has had or currently has lesions with a propensity to bleed (such as ulcers).

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical - Brisbane
Recruitment postcode(s) [1] 0 0
4000 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RDC Clinical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Briskey
Address 0 0
RDC Clinical
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bindu Nandanan
Address 0 0
Country 0 0
Phone 0 0
+65 9675 5193
Fax 0 0
Email 0 0
bindu.nandanan@dsm-firmenich.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06629103