An Evaluation of Omega-3 Fatty Acid



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:5/17/2017
Start Date:November 2016
End Date:May 2017

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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.

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).

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
We found this trial at
1
site
Miami, Florida 33143
Phone: 305-722-0970
?
mi
from
Miami, FL
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