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
Abstract
Background: Excessive hepatic fat is associated with increased metabolic risk factors, production of inflammatory factors, and oxidative stress. High protein intake might trigger an increased hepatic lipid oxidation through an increase in hepatic energy expenditure. Furthermore, the majority of randomized controlled trials (RCT) in humans have failed to show whether carotenoids can be used to prevent and treat non-alcoholic fatty liver disease (NAFLD). However, it is notable and contradictory that NAFLD is rapidly escalating in Iran and other countries with lower intakes of fruit and vegetables (as sources of β-cryptoxanthin [β-CX] and carbohydrates) and higher intake of carbohydrates (as an agent of NAFLD); and the effects of β-CX and a high protein diet (HPD) on NAFLD need to be investigated further.
Methods/design: 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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