An Evaluation of Omega-3 Fatty Acid

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017651
• Other study ID #: 16.20.CLI
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2017
• Last updated: May 15, 2017
• Start date: November 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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

Locations

Country	Name	City	State
United States	QPS/Miami Research Associates	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	Miami Research Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t	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	AUC0-inf	The plasma pharmacokinetics (AUC0-t) resulting from a single oral dose administration will be estimated from o to infinity	from 0 to infinity
Secondary	Cmax	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
Secondary	tmax	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
Secondary	t½	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