Pharmacokinetics of Omega-3 Monoglycerides

NCT04382027 | Completed DMC

• 1 other identifier: PK1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

North American diets have insufficient omega-3 fatty acid (n-3 FA) content. Consequently, they display low plasma concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the two main long chain n-3 FA. A quick and easy way to increase the level of dietary n-3 FA is to take supplements. However, people report side effects in using the currently available supplements, such as gastrointestinal discomfort, nausea and gastric reflux; especially those where EPA and DHA are esterified as ethyl esters (EE). Moreover, EE supplements are less absorbed compared to other esterification forms, such as mono-, di- or triglycerides. The objective of this study was to test the pharmacokinetics of a new n-3 FA supplementation formulation rich in FAs esterified as monoacylglyceride (MAG).

Conditions

Healthy

Keywords

Omega-3 fatty acids; Vitamin K2; Bioavailability; Monoacylglycerol; Pharmacokinetic

Outcome Measures

Primary Outcomes (2)

• The absorption of EPA and DHA in the plasma

  Define by the area under the curve between 0-5h

  0-5 hours

• The bioavailability of EPA and DHA in the plasma

  Define by the area under the curve between 0-24h

  0-24 hours

Secondary Outcomes (1)

• The maximum concentration of EPA and DHA in the plasma

  0-24 hours

Study Arms (2)

Monoacylglycerol

EXPERIMENTAL

The participant will arrive fasted at Diex Recherche Sherbrooke. After installing a catheter and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive the omega-3 fatty acids as a unique dose of 3 g EPA + DHA in monoacylglycerol form + 45 mg vitamin K2. The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of omega-3 fatty acids in the plasma.

Dietary Supplement: Omega-3 + vitamin K2 (monoacylglycerol form)

Ethyl ester

ACTIVE COMPARATOR

The participant will arrive fasted at Diex Recherche Sherbrooke. After installing a catheter and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive the omega-3 fatty acids as a unique dose of 3 g EPA + DHA in ethyl ester form + 45 mg vitamin K2. The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of omega-3 fatty acids in the plasma.

Dietary Supplement: Omega-3 + vitamin K2 (ethyl ester)

Interventions

Omega-3 + vitamin K2 (monoacylglycerol form) DIETARY_SUPPLEMENT

The intervention is a randomized double bond cross over design testing the pharmacokinetics of a monoglyceride formulation compared to an ethyl ester form. Treatments are randomly assigned on days 0 and 7 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform the two treatments, with a minimum of 6 days between treatments.

Monoacylglycerol

Omega-3 + vitamin K2 (ethyl ester) DIETARY_SUPPLEMENT

The intervention is a randomized double bond cross over design testing the pharmacokinetics of a monoglyceride formulation compared to an ethyl ester form. Treatments are randomly assigned on days 0 and 7 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform the two treatments, with a minimum of 6 days between treatments.

Ethyl ester

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged 18-60 years (inclusive Body mass index between 19 and 30 kg / m² (inclusive) at the pre-selection visit Individuals had to refrain from participating to other clinical studies involving experimental drugs for at least 30 days.
• Female of childbearing potential must have an adequate contraception

You may not qualify if:

• Person who consumed natural health products containing n-3 FAs in the last 6 months Allergy to fish or seafood Moderate-to-severe lipidemia (total cholesterol ≤ 240 mg/dl; LDL ≤ 160 mg/dl; Triglyceride ≤ 199 mg/dl) Tobacco or drug use Regular use of alcohol (females \> 10 drinks, males \> 14 drinks per week) Person who donated blood or had significant blood loss in the 56 days prior to study start Individuals with systolic blood pressure above 160 mmHg and diastolic blood pressure above 95 mmHg, or cardiac output at rest of less than 40 beats per minute or greater than 100 beats per minute.
• People presenting any cardiovascular, pulmonary, haematological, neurological, psychiatric, endocrine or immunological problems as well as any gastrointestinal tract, liver, kidney disease or other conditions that could affect the absorption of lipids Hypothyroidism Positive human chorionic gonadotropin, a hormone secreted during pregnancy

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de Recherche sur le Vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

Location

MeSH Terms

Interventions

Docosahexaenoic Acids; Vitamin K 2

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Study Officials

• Melanie Plourde, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the participant nor the research nurse will know the administration order of the different treatments administered. All plasma samples collected during the research project will be anonymized i.e. it will not be possible to identify the participant by his name since a number will be assigned to him. The code key linking the participant's name to his number will be stored, with access restricted to those designated by the principal investigator. The data file is also protected by a password.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Department of medicine, Geriatric service

Model Details: Double-blind controlled-randomized pharmacokinetic (PK) pilot study with crossover design (10 men and 10 women), with a minimum of 6 days between treatments

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: November 11, 2010
• Primary Completion: March 31, 2011
• Study Completion: May 5, 2020
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)