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Trial Outcomes & Findings for Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study (NCT NCT01285362)

NCT ID: NCT01285362

Last Updated: 2022-05-05

Results Overview

To evaluate the number of participants (young adults with obesity related NAFLD) that will normalize their elevated liver enzyme levels (normalized defined as having liver enzyme levels within a normal laboratory range) with supplements of fish oil (n-3 FA containing eicosapentanoic acid and docosahexaenoic acid).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

Up to 12 months from entry into the study

Results posted on

2022-05-05

Participant Flow

Participant milestones

Participant milestones
Measure
Fish Oil Supplementation (Group A)
Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA. Fish Oil Supplementation: Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA.
Placebo Supplementation (Group B)
Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules. Placebo Supplementation: Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules.
Overall Study
STARTED
4
4
Overall Study
COMPLETED
4
4
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Fish Oil Supplementation (Group A)
n=4 Participants
Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA. Fish Oil Supplementation: Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA.
Placebo Supplementation (Group B)
n=4 Participants
Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules. Placebo Supplementation: Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules.
Total
n=8 Participants
Total of all reporting groups
Age, Categorical
<=18 years
4 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
16 years
n=5 Participants
15 years
n=7 Participants
15.5 years
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
4 participants
n=5 Participants
4 participants
n=7 Participants
8 participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months from entry into the study

To evaluate the number of participants (young adults with obesity related NAFLD) that will normalize their elevated liver enzyme levels (normalized defined as having liver enzyme levels within a normal laboratory range) with supplements of fish oil (n-3 FA containing eicosapentanoic acid and docosahexaenoic acid).

Outcome measures

Outcome measures
Measure
Fish Oil Supplementation (Group A)
n=4 Participants
Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA. Fish Oil Supplementation: Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA.
Placebo Supplementation (Group B)
n=4 Participants
Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules. Placebo Supplementation: Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules.
Participants With Normalized Liver Enzyme Levels
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 12 months from entry into the study

Population: Plasma lipid levels were obtained for 6 participants (3 in each group).

The number of participants (young adults with obesity-related NAFLD and associated dyslipidemia) that will normalize plasma lipid levels (normalized defined as having plasma lipid levels within a normal laboratory range) after fish oil supplementation.

Outcome measures

Outcome measures
Measure
Fish Oil Supplementation (Group A)
n=3 Participants
Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA. Fish Oil Supplementation: Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA.
Placebo Supplementation (Group B)
n=3 Participants
Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules. Placebo Supplementation: Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules.
Number of Participants With Normalization of Plasma Lipid Levels
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 12 months from entry into the study

Population: Zero participants from group A were analyzed, as insulin levels were not collected at follow-up. Insulin levels were not collected at follow-up as insulin levels were within normal limits at baseline. Two participants in group B were analyzed; 2 of the 4 participants in group B had insulin levels collected at follow-up.

The number of participants (young adults with obesity related NAFLD and insulin resistance) that will attenuate insulin resistance (attenuation of insulin resistance defined as decrease in the body's need for insulin and measured by insulin levels and estimation of Homeostatic model assessment (HOMA-R) after fish oil supplementation.

Outcome measures

Outcome measures
Measure
Fish Oil Supplementation (Group A)
Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA. Fish Oil Supplementation: Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA.
Placebo Supplementation (Group B)
n=2 Participants
Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules. Placebo Supplementation: Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules.
Number of Participants With Insulin Resistance Attenuated
—
0 Participants

Adverse Events

Fish Oil Supplementation (Group A)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo Supplementation (Group B)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Mercedes Martinez

Columbia Universty

Phone: 212-305-3438

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place