An Evaluation of Omega-3 Fatty Acid

Phase 1

Completed

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: OM3-supplement 1; Dietary Supplement: OM3-supplement 2

• Registration Number: NCT03017651
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

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 Timeline

• Study Start: 2016-11
• Primary Completion: 2016-12
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-11
• Status Verified: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
OM3-supplement 1	OM3-supplement 1	1 g capsule for OM3-supplement 1 given once
OM3-supplement 2	OM3-supplement 2	1 g capsule for OM3-supplement 2 given once

Primary Outcome Measures

Name	Time	Method
AUC0-t	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

Secondary Outcome Measures

Name	Time	Method
tmax	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
t½	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
Cmax	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
AUC0-inf	from 0 to infinity	The plasma pharmacokinetics (AUC0-t) resulting from a single oral dose administration will be estimated from o to infinity

Trial Locations

Locations (1)

QPS/Miami Research Associates; 🇺🇸 Miami, Florida, United States