Effect of a high-protein diet with β-cryptoxanthin supplementation on metabolic risk factors, oxidative and inflammatory biomarkers in non-alcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled clinical trial

This study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for 12 weeks to receive daily β-CX 6 mg supplementation combined with a HPD on levels of metabolic factors, β-CX, glycemic and lipid profiles, inflammatory factors, adipocytokines, and body composition. Ninety-two eligible patients, aged 18–60 years, of both genders, who are obese and overweight (body mass index [BMI] 25– 40 kg/m2) will be randomly assigned to four groups as follow: HPD  + placebo; normal protein diet + β-CX (NPD + β-CX); HPD + β-CX; and NPD + placebo (control group). Two populations will be analyzed in this work. The intention-to-treat (ITT) population includes all patients who will be randomized, while the per-protocol (PP) population includes all individuals who complete the 12- week intervention (i.e. study completers).DiscussionOur findings from this trial will contribute to the knowledge of the relationship between β-CX supplementation and a HPD on NAFLD patients and determination of optimal macronutrient ratios without energy restriction.Trial registrationIran clinical trials registry,IRCT2017060210181N10. Registered on 20 June 2017.
Source: Trials - Category: Research Source Type: clinical trials