Non Alcoholic Fatty LiverNCT02923804
Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients
A study testing Omega-3 and Olive oil in people with Non Alcoholic Fatty Liver, run by Pronova BioPharma at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Alcoholic Fatty Liver
- What is being tested?
- Omega-3 and Olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2015to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 21Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Arlington
Arlington, Texas, 76012
Arlington
Arlington, Texas, 76015
Greenville
Greenville, South Carolina, 29615
Hialeah
Hialeah, Florida, 33012
Lake Worth
Lake Worth, Florida, 33461
Lauderdale Lakes
Lauderdale Lakes, Florida, 33319
Miami
Miami, Florida, 33185
About this study
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
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.
Read the 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.
- Conditions
- Non Alcoholic Fatty Liver
- Being tested
- Omega-3, Olive oil
- Keywords
- steatosis, NAFL, NAFLD, Polyunsaturated fatty acids, omega-3, EPA, DHA, fish oil
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
3x 1g capsules taken daily for 6 months
Olive oilDietary supplement
3x 1g capsules taken daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Experimental | 3 capsules of 1g concentrated omega-3 taken daily for 6 months Receives: Dietary Supplement: Omega-3 |
| Olive oil | Placebo comparator | 3 capsules of 1g olive oil taken daily for 6 months Receives: Dietary Supplement: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
• The primary endpoint is the difference in mean percent changes from baseline (Week 24 each with baseline subtracted) between placebo and omega-3 groups
Measured: 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)
Measured: 6 months
• Difference in mean percent change from baseline to end of treatment in omega-6: omega-3 ratios.
Measured: 6 months
To assess the impact of omega-3 on changes in liver fat as determined by MRI-PDFF
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startOct 2015
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pronova BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Derek Tobin, PhD, Study director, BASF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923804
- Sponsor's protocol ID
- 1051-001-PRO-19012015
- Status last verified
- Sep 2016
- First submitted
- 30 Sep 2016
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02923804
- Acronym / sponsor ID
- 1051-001-PRO-19012015
- Conditions
- Non Alcoholic Fatty Liver
- Keywords
- steatosis, NAFL, NAFLD, Polyunsaturated fatty acids, omega-3, EPA, DHA, fish oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Pronova BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- Oct 2015
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Experimental | Dietary Supplement: Omega-33 capsules of 1g concentrated omega-3 taken daily for 6 months |
| Olive oil | Placebo comparator | Dietary Supplement: Olive oil3 capsules of 1g olive oil taken daily for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-33x 1g capsules taken daily for 6 months | Dietary supplement | Omega-3 |
| Olive oil3x 1g capsules taken daily for 6 months | Dietary supplement | Olive oil |
Primary outcome
• 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
3 secondary outcomes
• 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
• Difference in mean percent change from baseline to end of treatment in omega-6: omega-3 ratios.
Time frame: 6 months
To assess the impact of omega-3 on changes in liver fat as determined by MRI-PDFF
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Non Alcoholic Fatty Liver
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Tobin, PhD study director
BASF
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 and Olive oil in people with Non Alcoholic Fatty Liver, run by Pronova BioPharma at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.