Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Investigation of the Effects of a Synbiotic on Liver Fat, Disease Biomarkers and Intestinal Microbiota in Non-alcoholic Fatty Liver Disease
Brief Summary: Non-alcoholic fatty liver disease (NAFLD) is a liver condition in which fat builds up in the liver not caused by alcohol. The liver is an organ that is not designed to build up fat. NAFLD is common in people who have too much body fat in their abdomen or who have diabetes (high blood sugar), but does not always exist with these conditions. NAFLD can also occur in thin people too. NAFLD can be harmful to the liver and may cause the liver to fail over time. NAFLD may also cause adult (or type 2) diabetes and also heart disease. In people who already have diabetes, NAFLD can cause glucose (sugar) levels to be too high.

Our intestines (guts) contain healthy bacteria and some harmful bacteria (bugs). This balance of healthy and harmful bugs is essential for the normal workings of our intestine to digest food. Providing these bacteria do not leak out into the blood they do not cause harm. If the balance of healthy to harmful bugs is upset, the harmful can cause problems and leak out into the blood. Because the liver is connected to the intestine by blood vessels the harmful bacteria can get to the liver and cause problems. These bacteria can cause the liver and the body to build up too much fat and might cause NAFLD and obesity. In this study, we will test the effects of a supplement (synbiotic) taken during the day, that contains a mixture of 'good' healthy bacteria (probiotic) and a sugar (prebiotic) that is not broken down and absorbed into the blood. We will test whether the synbiotic supplement has beneficial effects on the NAFLD liver condition and on factors linked to too much body fat, diabetes and heart disease.


Options:
A: Arm Label: Lower fat diet; Type: EXPERIMENTAL; Interventions: Behavioral: Weight loss | Arm Label: Lower carbohydrate diet; Type: EXPERIMENTAL; Interventions: Behavioral: Weight loss | Arm Label: Walnut-rich diet; Type: EXPERIMENTAL; Interventions: Behavioral: Weight loss | Intervention Type: BEHAVIORAL; Name: Weight loss; Assigned to Arm(s): Lower carbohydrate diet, Lower fat diet, Walnut-rich diet
B: 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
C: Arm Label: 1 Epanova; Type: EXPERIMENTAL; Interventions: Drug: Epanova | Arm Label: 2 Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Epanova | Intervention Type: DRUG; Name: Epanova; Assigned to Arm(s): 1 Epanova, 2 Placebo
D: 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

Answer: D