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CompletedNCT03017651Updated May 16, 2017

An Evaluation of Omega-3 Fatty Acid

A Phase 1 interventional study of OM3-supplement 1 and OM3-supplement 2 in Overweight and Obesity, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-16.

Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Overweight and Obesity
03

In context

Overweight

3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's enrollment of 30 is below the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    OM3-supplement 1

    1 g capsule for OM3-supplement 1 given once

    Dietary Supplement: OM3-supplement 1

  • Active comparator
    OM3-supplement 2

    1 g capsule for OM3-supplement 2 given once

    Dietary Supplement: OM3-supplement 2

Interventions

  • Dietary supplementOM3-supplement 1

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

  • Dietary supplementOM3-supplement 2

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

06

What researchers measure

Primary outcomes

  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

    Time frame: from 0 to 24 hours

Secondary outcomes

  1. AUC0-inf

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: between 0 and 24 hours

07

Study locations

1 site
  • QPS/Miami Research Associates
    Miami, Florida 33143, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03017651
Collaborators
Miami Research Associates
Responsible party
Sponsor
First posted
Jan 11, 2017
Start date
Nov 2016
Primary completion
Dec 2016
Completion
May 2017
Last update
May 16, 2017

Study contacts

Diane Krieger, MD
principal investigator · QPS-MRA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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