HealthyNCT04382027
Pharmacokinetics of Omega-3 Monoglycerides
A study testing Omega-3 + vitamin K2 (monoacylglycerol form) and Omega-3 + vitamin K2 (ethyl ester) in people with Healthy, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Omega-3 + vitamin K2 (monoacylglycerol form) and Omega-3 + vitamin K2 (ethyl ester)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 11 Nov 2010to 5 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de Recherche sur le Vieillissement
Sherbrooke, Quebec, J1H 4C4
About this study
Official title: Comparison of Pharmacokinetics of Omega-3 Fatty Acid Supplements in Monoacylglycerol or Ethyl Ester in Humans: a Randomized Controlled Trial.
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).
Read the detailed description
The growing presence on the North American as well as European market of food products enriched with fish oil as a source of polyunsaturated fatty acids (PUFA) omega-3 in the diet requires evaluation and comment. Research exploring health influence of the consumption of fish oil started in 1990 years. It was established that long-chain omega-3 PUFA (EPA C20:5 and DHA C22:6) has beneficial effect on human health. Fish oil is the main dietary source of long-chain omega-3 PUFA. Dietary recommendations suggest that the consumption of omega-3 PUFA should increase. The European Academy of Nutritional Sciences (EANS) and the United Kingdom dietary guidelines recommend a daily average intake of 0.2g of EPA plus DHA. In 2000, the Food and Drug Administration stated that the daily intake of EPA and DHA should increase up to 3.0 g per person in the form of fish oil, from food and dietary supplements. According to the World Health Organization recommendations for preventing cardiovascular diseases, one portion of fish should provide an equivalent of 200-500 mg of EPA and DHA. Due to the low fish consumption in developed societies, it seems reasonable to introduce fish oil in capsule supplement dosage forms and several food products enriched with fish oil that can be an additional source of the desirable long-chain omega-3 PUFA in the diet. For this purpose, reaching the recommended daily intake may require taking several capsules of fish oil per day.
Several studies have been performed to evaluate the potential health benefits brought by the consumption of food enriched with fish oil. Some studies suggest that different amounts of long-chain omega-3 - DHA and EPA, provided in a supplement form or added to food products, result in the same effect in changes in the blood lipid profile. The development of fish oil enriched food must be based on the scientific knowledge of the target function in the body and show that the effects are relevant for improved health or reduction of disease risk. The physiological effects of the intake of omega-3 fatty acids added to foods may differ depending on the quality of the fish oil used and the type of product.
Fish oil benefits range from decreasing risk of the so-called life-style diseases, particularly cardiovascular diseases, to combating depression, bipolar disorder and schizophrenia. Fish oil has also prophylaxis effects and treatment effects on inflammation, arthritis, anti-aging, age-related macular degeneration and mental health. Most of dietary lipids ingested from food consist of triacyglycerols. Prior to passive diffusion into the enterocytes, lipid digestion and emulsification are initiated by the action of different lipases resulting in the release of 2 free fatty acids and one monoglyceride-linked fatty acid. They are incorporated into mixed micelles to facilitate absorption into the bloodstream. The process of manufacturing the fish oil determines the quality which also depends on the type of fish used and the purity standards followed when refining the oil. Emulsified forms of fish oil have led to improved digestion and absorption of EPA and DHA in human healthy volunteers.
Flavored emulsified liquid preparations provide a simplified approach to fish oil delivery; emulsion as new approach seems to have advantages in the digestion and absorption of fatty acids which will increase the bioavailability. Using a novel approach of fish oil emulsification, preliminary results have indicated that both the rate and the extent of absorption of the fatty acids, particularly EPA and DHA, may be increased when digested. The present study was designed to establish that fish oil pre-emulsified using a novel approach will lead to increased absorption of EPA and DHA compared with the non-emulsified form of the fish oil.
- Conditions
- Healthy
- Being tested
- Omega-3 + vitamin K2 (monoacylglycerol form), Omega-3 + vitamin K2 (ethyl ester)
- Keywords
- Omega-3 fatty acids, Vitamin K2, Bioavailability, Monoacylglycerol, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Omega-3 + vitamin K2 (ethyl ester) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absorption of EPA and DHA in the plasma
Define by the area under the curve between 0-5h
Measured: 0-5 hours
The bioavailability of EPA and DHA in the plasma
Define by the area under the curve between 0-24h
Measured: 0-24 hours
Secondary outcomes (1)
The maximum concentration of EPA and DHA in the plasma
Define by the highest concentration achieved by the participants
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start11 Nov 2010
- Primary completion31 Mar 2011
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind controlled-randomized pharmacokinetic (PK) pilot study with crossover design (10 men and 10 women), with a minimum of 6 days between treatments
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mélanie Plourde, Université de Sherbrooke
- Investigators
- Melanie Plourde, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382027
- Sponsor's protocol ID
- PK1
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pharmacokinetics of Omega-3 Fatty Acid Supplements in Monoacylglycerol or Ethyl Ester in Humans: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04382027
- Acronym / sponsor ID
- PK1
- Conditions
- Healthy
- Keywords
- Omega-3 fatty acids, Vitamin K2, Bioavailability, Monoacylglycerol, Pharmacokinetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 11 Nov 2010 (actual)
- Primary completion
- 31 Mar 2011 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The growing presence on the North American as well as European market of food products enriched with fish oil as a source of polyunsaturated fatty acids (PUFA) omega-3 in the diet requires evaluation and comment. Research exploring health influence of the consumption of fish oil started in 1990 years. It was established that long-chain omega-3 PUFA (EPA C20:5 and DHA C22:6) has beneficial effect on human health. Fish oil is the main dietary source of long-chain omega-3 PUFA. Dietary recommendations suggest that the consumption of omega-3 PUFA should increase. The European Academy of Nutritional Sciences (EANS) and the United Kingdom dietary guidelines recommend a daily average intake of 0.2g of EPA plus DHA. In 2000, the Food and Drug Administration stated that the daily intake of EPA and DHA should increase up to 3.0 g per person in the form of fish oil, from food and dietary supplements. According to the World Health Organization recommendations for preventing cardiovascular diseases, one portion of fish should provide an equivalent of 200-500 mg of EPA and DHA. Due to the low fish consumption in developed societies, it seems reasonable to introduce fish oil in capsule supplement dosage forms and several food products enriched with fish oil that can be an additional source of the desirable long-chain omega-3 PUFA in the diet. For this purpose, reaching the recommended daily intake may require taking several capsules of fish oil per day.
Several studies have been performed to evaluate the potential health benefits brought by the consumption of food enriched with fish oil. Some studies suggest that different amounts of long-chain omega-3 - DHA and EPA, provided in a supplement form or added to food products, result in the same effect in changes in the blood lipid profile. The development of fish oil enriched food must be based on the scientific knowledge of the target function in the body and show that the effects are relevant for improved health or reduction of disease risk. The physiological effects of the intake of omega-3 fatty acids added to foods may differ depending on the quality of the fish oil used and the type of product.
Fish oil benefits range from decreasing risk of the so-called life-style diseases, particularly cardiovascular diseases, to combating depression, bipolar disorder and schizophrenia. Fish oil has also prophylaxis effects and treatment effects on inflammation, arthritis, anti-aging, age-related macular degeneration and mental health. Most of dietary lipids ingested from food consist of triacyglycerols. Prior to passive diffusion into the enterocytes, lipid digestion and emulsification are initiated by the action of different lipases resulting in the release of 2 free fatty acids and one monoglyceride-linked fatty acid. They are incorporated into mixed micelles to facilitate absorption into the bloodstream. The process of manufacturing the fish oil determines the quality which also depends on the type of fish used and the purity standards followed when refining the oil. Emulsified forms of fish oil have led to improved digestion and absorption of EPA and DHA in human healthy volunteers.
Flavored emulsified liquid preparations provide a simplified approach to fish oil delivery; emulsion as new approach seems to have advantages in the digestion and absorption of fatty acids which will increase the bioavailability. Using a novel approach of fish oil emulsification, preliminary results have indicated that both the rate and the extent of absorption of the fatty acids, particularly EPA and DHA, may be increased when digested. The present study was designed to establish that fish oil pre-emulsified using a novel approach will lead to increased absorption of EPA and DHA compared with the non-emulsified form of the fish oil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind controlled-randomized pharmacokinetic (PK) pilot study with crossover design (10 men and 10 women), with a minimum of 6 days between treatments
| Arm | Type | Receives |
|---|---|---|
| Monoacylglycerol | Experimental | Dietary Supplement: Omega-3 + vitamin K2 (monoacylglycerol form)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. |
| Ethyl ester | Active comparator | Dietary Supplement: Omega-3 + vitamin K2 (ethyl ester)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 + vitamin K2 (monoacylglycerol form)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. | Dietary supplement | Monoacylglycerol |
| Omega-3 + vitamin K2 (ethyl ester)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. | Dietary supplement | Ethyl ester |
Primary outcome
The absorption of EPA and DHA in the plasma
Time frame: 0-5 hours
Define by the area under the curve between 0-5h
The bioavailability of EPA and DHA in the plasma
Time frame: 0-24 hours
Define by the area under the curve between 0-24h
1 secondary outcome
The maximum concentration of EPA and DHA in the plasma
Time frame: 0-24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Plourde, PhD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 + vitamin K2 (monoacylglycerol form) and Omega-3 + vitamin K2 (ethyl ester) in people with Healthy, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absorption of EPA and DHA in the plasma (time frame: 0-5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.