Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)

Epax

Status: Unknown

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Fish oil; Dietary Supplement: Ceto 10; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04768595

P2008

Details and patient eligibility

About

The study determines the EPA DHA uptake from different omega-3 supplements against a control.

Full description

The chronic uptake of omega-3 fatty acids EPA and DHA are commonly determined by measurement of EPA and DHA in red bloods cells and presented as a % of total fatty acids, the so-called Omega-3 Index. The index is a validated risk assessment for cardiovascular disease. Different fish oils may influence the Omega-3 Index differently depending on their composition. This study assesses omega-3 commonly found as a supplement vs a fish oil based on north atlantic fish species.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Men or women, ≥18 -65 years of age.
2. Willing to refrain from taking omega-3 supplements for 1 month prior to study start
3. Willing to take study supplement for 2 months

Exclusion criteria

1. Subjects with known allergy to fish products
2. Subjects known to be pregnant or breast feeding

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

1g corn oil capsules

Treatment:

Dietary Supplement: Placebo

Ceto 10

Experimental group

Description:

1g capsules containing oil from north atlantic fish containing broad spectrum marine oil.

Treatment:

Dietary Supplement: Ceto 10

Omega-3

Active Comparator group

Description:

1 g capsules containing traditional, commericially available omega-3 marine oil.

Treatment:

Dietary Supplement: Fish oil