Comparing the Pharmacological Profile of Formulations Containing Omega 3 Fatty Acids

Factors Group of Nutritional Companies

Status: Completed

Conditions: Pharmacokinetics

Treatments: Dietary Supplement: Omega-3 LipoMicel® soft gels; Dietary Supplement: RxOmega-3 soft gels (Enteric); Dietary Supplement: Omega-3 Complete soft gels (Non-Enteric)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05394701

2021-10-002

Details and patient eligibility

About

The primary objective of this study is to investigate the uptake/gastrointestinal absorption of fatty acids in healthy adult volunteers by using enteric coated and non-enteric coated soft capsules containing omega 3 fatty acids. Pharmacokinetic parameters such as AUC and Cmax, as well as any adverse events are recorded.

As secondary objective, the short-term effects of Omega-3 supplementation on blood lipid parameters in healthy volunteers are evaluated using a Cholestech LDX analyzer to measure cholesterol and related lipids.

Enrollment: 12 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 21-65
• healthy, good physical condition

Exclusion criteria

• Pregnancy or breast-feeding
• Gastrointestinal conditions
• Acute or chronic liver disease
• Acute or chronic kidney disease
• Acute or chronic cardiovascular disease
• Allergy or Intolerance to gluten
• Allergy or Intolerance to fish or shellfish
• Use of medications (e.g., anticoagulants/ blood thinners such as warfarin; blood lipid-lowering agents such as statins)
• Use of Fish oil supplements
• Use of any form of nicotine or tobacco
• Alcohol and substance abuse history
• Participation in another investigational study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 3 patient groups

RxOmega-3 soft gels (Enteric)

Experimental group

Description:

Each participant receives their treatment of RxOmega-3 soft gel (Enteric) capsules at a total dose of 1260 mg Omega-3 Fatty Acids. Treatments are consumed with a glass of water (approx. 200 mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours. Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 14 days between each treatment will be used. Adverse events are recorded throughout the study by direct questioning.

Treatment:

Dietary Supplement: RxOmega-3 soft gels (Enteric)

Omega-3 Complete soft gels (Non-Enteric)

Experimental group

Description:

Each participant receives their treatment of Omega-3 Complete soft gel (Non-Enteric) capsules at a total dose of 1260 mg Omega-3 Fatty Acids. Treatments are consumed with a glass of water (approx. 200 mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours. Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 14 days between each treatment will be used. Adverse events are recorded throughout the study by direct questioning.

Treatment:

Dietary Supplement: Omega-3 Complete soft gels (Non-Enteric)

Omega-3 LipoMicel® soft gels

Experimental group

Description:

Each participant receives their treatment of Omega-3 LipoMicel® soft gel capsules at a total dose of 1260 mg Omega-3 Fatty Acids. Treatments are consumed with a glass of water (approx. 200 mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours. Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 14 days between each treatment will be used. Adverse events are recorded throughout the study by direct questioning.

Treatment:

Dietary Supplement: Omega-3 LipoMicel® soft gels