An Evaluation of Omega-3 Fatty Acid

NCT03017651 | Completed Phase 1

• 1 other identifier: 16.20.CLI
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight and Obesity

Outcome Measures

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

  from 0 to 24 hours

Secondary Outcomes (4)

• AUC0-inf

  from 0 to infinity

• Cmax

  between 0 and 24 hours

• tmax

  between 0 and 24 hours

• t½

  between 0 and 24 hours

Study Arms (2)

OM3-supplement 1

EXPERIMENTAL

1 g capsule for OM3-supplement 1 given once

Dietary Supplement: OM3-supplement 1

OM3-supplement 2

ACTIVE COMPARATOR

1 g capsule for OM3-supplement 2 given once

Dietary Supplement: OM3-supplement 2

Interventions

OM3-supplement 1 DIETARY_SUPPLEMENT

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

OM3-supplement 1

OM3-supplement 2 DIETARY_SUPPLEMENT

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

OM3-supplement 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Currently following a self-reported no-fat or ultra-restrictive (less than 15%) Low-Fat Diet
• Having the following medical conditions:
• i. Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc.
• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Miami Research Associates: collaborator

Study Sites (1)

QPS/Miami Research Associates

Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Diane Krieger, MD

  QPS-MRA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 11, 2017
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)