Bioavailability Study of Long Chain Omega-3 Fatty Acids From a Gastric Stable Emulsion

Ayanda

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: Omega-3 oils from tri-glycerides; Dietary Supplement: Omega-3 oils from marine phospholipids

Study type: Interventional

Funder types: Industry

Identifiers

NCT01061554

AYANDA-CC-01

Details and patient eligibility

About

The purpose of this study is to compare the short term absorption of EPA and DHA from triglycerides (TG) released from normal soft gel capsules and from the new patent pending vehicle providing a gastric stable emulsion.

Full description

The present study comprises the design of as well as the effect of pre-emulsification of ω-3 fatty acids on the bioavailability of docosahexaenoic acid and eicosapentaenoic acid. In-vitro studies have shown that long-term steric stabilization of an o/w-emulsion is obtained by arresting the oil droplets in a gelatin continuous gel matrix. The emulsion was also stable upon dissolution of the gel matrix at physiological conditions in-vitro and is hence referred to as a gastric stable emulsion (GSE).

In the bioavailability study, healthy young students were recruited and presented two different single-dose treatments of fish oil containing 5 grams of ω-3 fatty acids; one group receiving the fatty acids in traditional soft gel capsules, whereas the other group received the fatty acids using the GSE technology. Time resolved (2 - 26 hours) blood plasma analysis after intake of this single dose ω-3 fatty acids revealed significantly increased AUC0-26h and Cmax of EPA and EPA + DHA when administered as GSE compared to traditional soft gel capsules.

Enrollment: 27 patients

Sex: All

Ages: 19 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Student at Nord-Trondelag University College
• Healthy (no known condition)
• Males and females aged 19 to 29 years

Exclusion criteria

• Fish allergies
• Ongoing consumption of omega-3 fatty acids
• Subjects receiving anticoagulation or non-steroid anti-inflammatory treatment
• Subjects with a known metabolic syndrome; diabetes, hypercholesterol, hypertension, obesity

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 3 patient groups

Gastric stable emulsion

Experimental group

Description:

A gastric stable emulsion vehicle for administration of tri-glyceride based omega-3 oils

Treatment:

Dietary Supplement: Omega-3 oils from tri-glycerides

Soft gel capsule (TG)

Active Comparator group

Description:

Soft gel capsule for administration of tri-glyceride based omega-3 oils

Treatment:

Dietary Supplement: Omega-3 oils from tri-glycerides

Soft gel capsules (MPL)

Active Comparator group

Description:

Soft gel capsule for administration of marine phospholipids based omega-3 oils

Treatment:

Dietary Supplement: Omega-3 oils from marine phospholipids