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Overweight and ObesityPhase 1NCT03017651

An Evaluation of Omega-3 Fatty Acid

A Phase 1 study testing OM3-supplement 1 and OM3-supplement 2 in people with Overweight and Obesity, run by Société des Produits Nestlé (SPN) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
OM3-supplement 1 and OM3-supplement 2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Nov 2016to May 2017
Phase
Phase 1
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female subjects between 18 and 65 years old (inclusive)
  • Body Mass Index (BMI) between 25.0 and 34.9 kg/m2 (inclusive) at Screening.
  • 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).
  • 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.
  • 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.
  • 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

Who cannot join

  • Currently using fish oil capsules (supplements or prescription products).
  • Regular use of omega-3 supplements (defined as greater than 500 mg/week) within 4 weeks of study product administration.
  • Currently using any medications that may impact dietary fat absorption (i.e., Orlistat, Alli, etc.).
  • Currently using any medications that may interfere with omega-3 uptake (i.e. blood thinning medication or anticoagulants).
  • Currently using any lipid lowering medications (i.e. any cholesterol or triglyceride lowering agent).
  • Currently consuming high amounts of EPA \& DHA in the diet (as defined by greater than 200 mg/day by FFQ)
Show all 22Show fewer
  • Currently following a self-reported no-fat or ultra-restrictive (less than 15%) Low-Fat Diet
  • Having the following medical conditions:
  • Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc.
  • 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
  • Currently a smoker or nicotine user or has been nicotine free for less than 6 months
  • 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)
  • Evidence or history of allergic or adverse responses to either study product, any of the product excipients or any comparable or similar products
  • Subjects who are not willing and not able to comply with scheduled visits and the requirements of the study protocol.
  • Female subjects who are breastfeeding, pregnant or plan to become pregnant during this study.
  • Current employee or immediate family member of the study sponsor or study site personnel.
  • Currently participating or have participated in another clinical trial within 4 weeks of study product administration
  • Donated blood, blood components, or significant loss of blood within 30 days of study product administration
  • History of a clinically-significant illness within 4 weeks of study product administration
  • History of hospitalization or treatment for clinically-significant drug or alcohol use/abuse within 1 year of dosing.
  • Subject has poor venous access or difficulty swallowing capsules
  • Any other issue which, in the judgment of the Investigator, will make the subject ineligible for study participation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • QPS/Miami Research Associates

    Miami, Florida, 33143

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
OM3-supplement 1, OM3-supplement 2
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OM3-supplement 1Dietary supplement

    1g of OM3-supplement 1 will be given to subjects to look at DHA/EPA blood absorption

  • OM3-supplement 2Dietary supplement

    1g of OM3-supplement 2 will be given to subjects to look at DHA/EPA blood absorption

Study groups in NCT03017651
Study groupRoleWhat they receive
OM3-supplement 1Experimental1 g capsule for OM3-supplement 1 given once
Receives: Dietary Supplement: OM3-supplement 1
OM3-supplement 2Active comparator1 g capsule for OM3-supplement 2 given once
Receives: Dietary Supplement: OM3-supplement 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-t

    The plasma pharmacokinetics (AUC0-t) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose

    Measured: from 0 to 24 hours

Secondary outcomes (4)

  1. AUC0-inf

    The plasma pharmacokinetics (AUC0-t) resulting from a single oral dose administration will be estimated from o to infinity

    Measured: from 0 to infinity

  2. Cmax

    The plasma pharmacokinetics (Cmax) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose

    Measured: between 0 and 24 hours

  3. tmax

    The plasma pharmacokinetics (tmax) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose

    Measured: between 0 and 24 hours

  4. t½

    The plasma pharmacokinetics (t1/2) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose

    Measured: between 0 and 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2017 (estimated)
  2. Study startNov 2016
  3. Primary completionDec 2016
  4. Study completionMay 2017

Resources

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 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03017651
Sponsor's protocol ID
16.20.CLI
Status last verified
May 2017
First submitted
10 Jan 2017
Last updated
16 May 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OM3-supplement 1 and OM3-supplement 2 in people with Overweight and Obesity, run by Société des Produits Nestlé (SPN) at 1 site in United States.

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 6 inclusion and 22 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 16 May 2017. 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 United States. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

AUC0-t (time frame: from 0 to 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03017651.

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 16 May 2017.

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