NCT02923804

Brief Summary

This study is a prospective, randomized, placebo-controlled, double-blind trial to determine the effect of high concentrate omega-3 capsules on the omega-3 status of patients with non-alcoholic fatty liver.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 30, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 4, 2018

Status Verified

September 1, 2016

Enrollment Period

2.2 years

First QC Date

September 30, 2016

Last Update Submit

April 3, 2018

Conditions

Non Alcoholic Fatty Liver

Keywords

steatosisNAFLNAFLDPolyunsaturated fatty acidsomega-3EPADHAfish oil

Outcome Measures

Primary Outcomes (1)

  • • The primary endpoint is the difference in mean percent changes from baseline (Week 24 each with baseline subtracted) between placebo and omega-3 groups

    6 months

Secondary Outcomes (3)

  • • Difference in mean percent change from baseline to end-of-treatment in RBC EPA and RBC DHA (percentage of lipids and quantitative measurements)

    6 months

  • • Difference in mean percent change from baseline to end of treatment in omega-6: omega-3 ratios.

    6 months

  • To assess the impact of omega-3 on changes in liver fat as determined by MRI-PDFF

    6 months

Study Arms (2)

Omega-3

EXPERIMENTAL

3 capsules of 1g concentrated omega-3 taken daily for 6 months

Dietary Supplement: Omega-3

Olive oil

PLACEBO COMPARATOR

3 capsules of 1g olive oil taken daily for 6 months

Dietary Supplement: Olive oil

Interventions

Omega-3DIETARY_SUPPLEMENT

3x 1g capsules taken daily for 6 months

Omega-3
Olive oilDIETARY_SUPPLEMENT

3x 1g capsules taken daily for 6 months

Olive oil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented history of clinical diagnosis of NAFLD by ultrasound, MRI or biopsy within one (1) year prior to screening (V1). If the diagnostic test date is greater than one (1) year, abdominal ultrasound will be repeated at (V1) and must confirm a diagnosis of NAFLD.
  • Men or women, ≥18 years of age.
  • BMI between 18.0 and 39.9 kg/m2.
  • Non-smokers (\>3 months of non-smoking).
  • If on a statin regimen, history (\> 1 month stable dose) of taking a statin medication (HMG-CoA reductase inhibitor example: Lipitor, Zocor, Crestor, Pravachol, Lescol, Livalo, etc).
  • Able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures.

You may not qualify if:

  • Diagnosis of NASH.
  • Bilirubin \>2x ULN.
  • Other causes of liver inflammation including Hepatitis A, B or C, HIV, confirmed or suspected cirrhosis, Wilson's disease, autoimmune hepatitis, hemochromatosis, alcoholic steatohepatitis, pancreatitis, or prescription medications known to cause liver damage, or known to be hepatotoxic.
  • Subjects with a history of bariatric surgery.
  • Significant weight loss (\> 5% body weight) or rapid weight loss (\>1.6 kg/week), within six months of screening.
  • Current or recent (within six months of screening) history of significant gastrointestinal, renal, pulmonary, hepatic or biliary disease, endocrine diseases or other invasive weight loss treatments (Type II Diabetes permitted, and stable (\> 3 months) thyroid disorders).
  • Individual taking prescription or over-the-counter medications (including dietary supplements, see Appendix 1) known to alter lipid metabolism, within four (4) weeks of randomization. These medications include (but are not limited to) the following: bile acid sequestrants, cholesterol absorption inhibitors, niacin or fibrates,
  • Individuals taking prescription omega-3 fatty acids.
  • Use of supplements including Omega-3s and Omega-6s, other oil-based supplements, phytosterols, Vitamin E, prebiotics and probiotics, or any weight loss supplements within four (4) weeks of randomization (multivitamins and minerals containing Vitamin E are permitted).
  • Use of systemic corticosteroids, androgens (except androgens for hypogonadism to restore normal levels), phenytoin, erythromycin and other macrolides, thiazolidinediones (e.g. pioglitazone), and thyroid hormones (except stable-dose thyroid replacement therapy for four (4) weeks prior to enrollment).
  • Use of the anticoagulants warfarin (Coumadin), dabigatran (Pradaxa), apixaban (Eliquis) or rivaroxaban (Xarelto). NOTE: Anti-platelet agents such as Plavix are allowed.
  • Pregnant or lactating women or women of childbearing potential, who are not using an approved method of contraception. A woman is considered to be of childbearing potential unless she is post-hysterectomy, one or more years postmenopausal, or one or more years post-tubal ligation.
  • History of significant cardiovascular or coronary heart disease (CVD or CHD) as defined by having had a coronary artery bypass procedure, coronary stent or angioplasty, or myocardial infarction in the previous six (6) months.
  • History of cancer, other than non-melanoma skin cancer and basal cell carcinoma, within the previous five years.
  • Poorly controlled or uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥95 mmHg).
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hialeah

Hialeah, Florida, 33012, United States

Location

Lake Worth

Lake Worth, Florida, 33461, United States

Location

Lauderdale Lakes

Lauderdale Lakes, Florida, 33319, United States

Location

Miami

Miami, Florida, 33185, United States

Location

Greenville

Greenville, South Carolina, 29615, United States

Location

Arlington

Arlington, Texas, 76012, United States

Location

Arlington

Arlington, Texas, 76015, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseFatty Liver

Interventions

Docosahexaenoic AcidsOlive Oil

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Derek Tobin, PhD

    BASF

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2016

First Posted

October 5, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 4, 2018

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(7)