Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients
Primary Purpose
Non Alcoholic Fatty Liver
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3
Olive oil
Sponsored by
About this trial
This is an interventional treatment trial for Non Alcoholic Fatty Liver focused on measuring steatosis, NAFL, NAFLD, Polyunsaturated fatty acids, omega-3, EPA, DHA, fish oil
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- Recent history of prolonged alcohol (>3 months) use (within past 6 months) or excessive alcohol use, defined as >14 drinks per week (one drink = 12 oz. beer, 4 oz. wine, 1.5 oz. hard liquor).
- Exposure to any investigational agent within four (4) weeks prior to Visit 1.
- Subjects planning to undergo surgery during the study period or up to 1 month after the study
- Any serious psychiatric disease or disorder, which, in the opinion of the investigator, would preclude the subject from participating in the study.
- Any known intolerance to the investigational ingredients of this medical food.
- Has a condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk during the course of the study, including potentially abnormal lab results, due to a traumatic event.
Sites / Locations
- Hialeah
- Lake Worth
- Lauderdale Lakes
- Miami
- Greenville
- Arlington
- Arlington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omega-3
Olive oil
Arm Description
3 capsules of 1g concentrated omega-3 taken daily for 6 months
3 capsules of 1g olive oil taken daily for 6 months
Outcomes
Primary Outcome Measures
• The primary endpoint is the difference in mean percent changes from baseline (Week 24 each with baseline subtracted) between placebo and omega-3 groups
Secondary Outcome Measures
• Difference in mean percent change from baseline to end-of-treatment in RBC EPA and RBC DHA (percentage of lipids and quantitative measurements)
• Difference in mean percent change from baseline to end of treatment in omega-6: omega-3 ratios.
To assess the impact of omega-3 on changes in liver fat as determined by MRI-PDFF
Full Information
NCT ID
NCT02923804
First Posted
September 30, 2016
Last Updated
April 3, 2018
Sponsor
Pronova BioPharma
Collaborators
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02923804
Brief Title
Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients
Official Title
A Randomized, Double-Blind, Placebo-Controlled Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients When Added to Standard of Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pronova BioPharma
Collaborators
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Subjects with non-alcoholic fatty liver (simple steatosis) confirmed within the last year by ultrasound or other imaging modality will be recruited to the study. Subjects will be randomized to a treatment arm of high concentrate capsules or placebo for a 6 month treatment period.Omega-3 content of red blood cells (omega-3 index) will be measured for primary endpoint assessment. Quantitative MRI will be performed to determine the effect on liver fat content.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Fatty Liver
Keywords
steatosis, NAFL, NAFLD, Polyunsaturated fatty acids, omega-3, EPA, DHA, fish oil
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega-3
Arm Type
Experimental
Arm Description
3 capsules of 1g concentrated omega-3 taken daily for 6 months
Arm Title
Olive oil
Arm Type
Placebo Comparator
Arm Description
3 capsules of 1g olive oil taken daily for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Intervention Description
3x 1g capsules taken daily for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive oil
Intervention Description
3x 1g capsules taken daily for 6 months
Primary Outcome Measure Information:
Title
• The primary endpoint is the difference in mean percent changes from baseline (Week 24 each with baseline subtracted) between placebo and omega-3 groups
Time Frame
6 months
Secondary Outcome Measure Information:
Title
• Difference in mean percent change from baseline to end-of-treatment in RBC EPA and RBC DHA (percentage of lipids and quantitative measurements)
Time Frame
6 months
Title
• Difference in mean percent change from baseline to end of treatment in omega-6: omega-3 ratios.
Time Frame
6 months
Title
To assess the impact of omega-3 on changes in liver fat as determined by MRI-PDFF
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Recent history of prolonged alcohol (>3 months) use (within past 6 months) or excessive alcohol use, defined as >14 drinks per week (one drink = 12 oz. beer, 4 oz. wine, 1.5 oz. hard liquor).
Exposure to any investigational agent within four (4) weeks prior to Visit 1.
Subjects planning to undergo surgery during the study period or up to 1 month after the study
Any serious psychiatric disease or disorder, which, in the opinion of the investigator, would preclude the subject from participating in the study.
Any known intolerance to the investigational ingredients of this medical food.
Has a condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk during the course of the study, including potentially abnormal lab results, due to a traumatic event.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek Tobin, PhD
Organizational Affiliation
BASF
Official's Role
Study Director
Facility Information:
Facility Name
Hialeah
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Lake Worth
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Lauderdale Lakes
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients
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