Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
Brief Summary: Nonalcoholic steatohepatitis (NASH) occurs in 2-3% of the US population and carries a 15-20% chance of progression to cirrhosis. It is closely associated with obesity, hyperlipidemia and insulin resistance. Therapy usually includes recommendations to increase exercise and to begin weight reducing diets but these goals are variably achieved and their relative effects in conjunction with pharmacological intervention have not been well defined. Moreover, these lifestyle changes can confound results of treatment trials if not quantified through conditioning testing and measures of body fat. Polyunsaturated fatty acids, especially formulation rich in omega-3, are widely accepted and endorsed in the medical community for their beneficial effects on hyperlipidemia and coronary disease risk reduction. Recent data suggests that omega-3 fatty acids ameliorate hepatic steatosis in humans and in animal models of NASH by reducing hepatic fat content. We hypothesize that a one year course of omega-3 fatty acid (3gm/day) will produce improvement in NASH histological injury independent of changes in weight (BMI) or degree of conditioning measured by the lactate threshold. The effects of the supplement will be compared to a placebo group and controlled for these lifestyle changes.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Dietary Supplement: omega-3 | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Dietary Supplement: omega-3, Behavioral: multi-domain intervention | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Behavioral: multi-domain intervention, Drug: Placebo | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: omega-3; Assigned to Arm(s): 1, 2 | Intervention Type: BEHAVIORAL; Name: multi-domain intervention; Assigned to Arm(s): 2, 3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 3, 4
B: Arm Label: Synbiotic; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Synbiotic | Arm Label: Maltodextrin; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Maltodextrin | Intervention Type: DIETARY_SUPPLEMENT; Name: Synbiotic; Assigned to Arm(s): Synbiotic | Intervention Type: DIETARY_SUPPLEMENT; Name: Maltodextrin; Assigned to Arm(s): Maltodextrin
C: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo capsule | Arm Label: EPA-E 1800 mg/day; Type: EXPERIMENTAL; Interventions: Drug: EPA-E 300 mg capsule | Arm Label: EPA-E 2700 mg/day; Type: EXPERIMENTAL; Interventions: Drug: EPA-E 300 mg capsule | Intervention Type: DRUG; Name: Placebo capsule; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: EPA-E 300 mg capsule; Assigned to Arm(s): EPA-E 1800 mg/day | Intervention Type: DRUG; Name: EPA-E 300 mg capsule; Assigned to Arm(s): EPA-E 2700 mg/day
D: Arm Label: Omega 3 recipient arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Omega 3 Fish Oil supplements | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Omega 3 Fish Oil supplements; Assigned to Arm(s): Omega 3 recipient arm | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D