An Evaluation of Omega-3 Fatty Acid

May 15, 2017 updated by: Nestlé

An Evaluation of a Proprietary Omega-3 Fatty Acid Incorporated Into a MAG on Blood EPA and DHA Levels: a PK Study

This protocol will determine the pK profile of two different omega-3 fatty acid supplements on plasma EPA and DHA levels.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This protocol is to assess the omega-3 blood levels of DHA and EPA following a single dose administration of study products by means of pharmacokinetics over a 24 hour period of time (post-dose).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33143
        • QPS/Miami Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Male or female subjects between 18 and 65 years old (inclusive)
  2. Body Mass Index (BMI) between 25.0 and 34.9 kg/m2 (inclusive) at Screening.
  3. Subjects with normal or moderately elevated lipidemia (borderline lipids as defined by the AACE - Total cholesterol ≤ 240 mg/dl; LDL ≤ 160 mg/dl; TG ≤ 199 mg/dl).
  4. Subjects with no clinically significant findings in the physical examination, medical history, vital signs, clinical laboratory test (hematology and serum chemistry) results and as deemed by the Investigator.
  5. Subjects must understand and agree to comply with the requirements of the study and they must be willing to sign the informed consent indicating voluntary consent to participate in the study prior to the initiation of Screening or study related activities.
  6. Male and female subjects of childbearing potential must agree to use one of the following medically acceptable contraceptive methods for the duration of the study: same-sex partner; double barrier (condom, diaphragm or cervical cap with spermicidal foam, gel or cream); IUD (with or without hormones) in place or hormonal contraception (oral, injectable, implantable, transdermal or vaginal) used consecutively for at least 3 months prior to study product administration; vasectomized partner or sterilization by bilateral insertion of Essure® or similar product for 6 months minimum prior to study product administration; bilateral tubal ligation, hysterectomy and/or bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to study product administration

Exclusion Criteria:

  1. Currently using fish oil capsules (supplements or prescription products).
  2. Regular use of omega-3 supplements (defined as greater than 500 mg/week) within 4 weeks of study product administration.
  3. Currently using any medications that may impact dietary fat absorption (i.e., Orlistat, Alli, etc.).
  4. Currently using any medications that may interfere with omega-3 uptake (i.e. blood thinning medication or anticoagulants).
  5. Currently using any lipid lowering medications (i.e. any cholesterol or triglyceride lowering agent).
  6. Currently consuming high amounts of EPA & DHA in the diet (as defined by greater than 200 mg/day by FFQ)
  7. Currently following a self-reported no-fat or ultra-restrictive (less than 15%) Low-Fat Diet

  8. Having the following medical conditions:

    i. Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc.

    ii. Hypertriglyceridemia (as defined by the Inclusion and per PI discretion; Total cholesterol > 240 mg/dl; LDL > 160 mg/dl; TG > 199 mg/dl) iii. Type2 Diabetes Mellitus

  9. Currently a smoker or nicotine user or has been nicotine free for less than 6 months
  10. Use of any systemic medications, including OTC medications, herbal products, dietary supplements or vitamins (not previously listed) within 1 week of study product administration (occasional use of OTC analgesics such as acetaminophen may be allowed as judged by the Investigator)
  11. Evidence or history of allergic or adverse responses to either study product, any of the product excipients or any comparable or similar products
  12. Subjects who are not willing and not able to comply with scheduled visits and the requirements of the study protocol.
  13. Female subjects who are breastfeeding, pregnant or plan to become pregnant during this study.
  14. Current employee or immediate family member of the study sponsor or study site personnel.
  15. Currently participating or have participated in another clinical trial within 4 weeks of study product administration
  16. Donated blood, blood components, or significant loss of blood within 30 days of study product administration
  17. History of a clinically-significant illness within 4 weeks of study product administration
  18. History of hospitalization or treatment for clinically-significant drug or alcohol use/abuse within 1 year of dosing.
  19. Subject has poor venous access or difficulty swallowing capsules
  20. Any other issue which, in the judgment of the Investigator, will make the subject ineligible for study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OM3-supplement 1
1 g capsule for OM3-supplement 1 given once
Dietary supplement: OM3-supplement 1
1g of OM3-supplement 1 will be given to subjects to look at DHA/EPA blood absorption
Active Comparator: OM3-supplement 2
1 g capsule for OM3-supplement 2 given once
Dietary supplement: OM3-supplement 2
1g of OM3-supplement 2 will be given to subjects to look at DHA/EPA blood absorption

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC0-t
Time Frame: from 0 to 24 hours
The plasma pharmacokinetics (AUC0-t) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose
from 0 to 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUC0-inf
Time Frame: from 0 to infinity
The plasma pharmacokinetics (AUC0-t) resulting from a single oral dose administration will be estimated from o to infinity
from 0 to infinity
Cmax
Time Frame: between 0 and 24 hours
The plasma pharmacokinetics (Cmax) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose
between 0 and 24 hours
tmax
Time Frame: between 0 and 24 hours
The plasma pharmacokinetics (tmax) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose
between 0 and 24 hours
t½
Time Frame: between 0 and 24 hours
The plasma pharmacokinetics (t1/2) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose
between 0 and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nestlé

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Miami Research Associates

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diane Krieger, MD, QPS-MRA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16.20.CLI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight and Obesity

Clinical Trials on OM3-supplement 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings