Background: Studies have shown that pre/postnatal undernutrition leads to higher risk of non communicable diseases such as diabetes, hypertension and obesity in adulthood.
Background
Despite promising animal data, there is no randomized controlled trial (RCT) on the effects of high protein (HP)-diet and/or β-cryptoxanthin in non-alcoholic fatty liver disease (NAFLD). Aims: Safety and efficacy assessment of a hypocaloric HP-diet supplemented with β-cryptoxanthin in NAFLD.
Methods
Ninety-two Iranian NAFLD outpatients were recruited for this 12-week, single-center, parallel-group, double-blind RCT and randomized into 4 arms (n = 23): HP-diet and β-cryptoxanthin (hypocaloric HP-diet + β-cryptoxanthin), HP-diet (hypocaloric HP-diet + placebo), β-cryptoxanthin (standard hypocaloric diet + β-cryptoxanthin), and control (standard hypocaloric diet + placebo). Serum levels of liver enzymes and grade of hepatic steatosis were assessed at baseline and study endpoint as outcome measures.
Results
In the intention-to-treat population (N = 92), HP-diet and β-cryptoxanthin group experienced greater 12-week reductions in serum levels of liver enzymes than control group (mean difference for alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and gamma-glutamyl transferase: − 27.2, − 7.2, − 39.2, and − 16.3 IU/L, respectively; all p < 0.010). Clinical remission rate (achieving grade 0 hepatic steatosis) in HP-diet and β-cryptoxanthin group (82.6%) was also higher than other groups (13.0%, 17.4%, and 0.0% in HP-diet, β-cryptoxanthin, and control groups, respectively; p < 0.001). Sixteen patients reported minor adverse events.
Conclusion
A hypocaloric HP-diet supplemented with β-cryptoxanthin safely and efficaciously improves NAFLD.
Trial registration number
This trial was registered at https://www.irct.ir as IRCT2017060210181N10.
Metabolic syndrome (MetS) is a chronic disease with inflammatory and hypercoagulable states. The current study aimed to compare the effects of flaxseed oil and sunflower oil consumption on the coagulation score and selected oxidative and inflammatory parameters in patients with MetS. In this randomized controlled clinical trial, 60 patients with MetS were allocated into 2 groups. One group received 25 mL/day flaxseed oil and the other group received 25 mL/day sunflower oil for 7 weeks. Maintenance diet including 15% protein, 55% carbohydrate, and 30% fat from daily total energy intake was designed for each participant. Serum levels of total antioxidant capacity (TAC) and interleukin 6 (IL-6), as well as coagulation score were measured before and after the intervention. Three 24-hour food records were taken during the study. Fifty-two of participants (27 in sunflower oil and 25 in flaxseed oil groups) completed the study. The baseline characteristics and dietary intakes were similar between patients. After 7 weeks, no significant difference was observed between the 2 groups regarding the serum TAC level and coagulation score (p > 0.05). However, serum IL-6 levels significantly decreased in the flaxseed oil group compared to the sunflower oil group (p = 0.017). No side effect was observed during the study due to the use of sunflower and flaxseed oils. We observed that consumption of flaxseed oil improved serum IL-6 levels but had no effect on oxidative stress and coagulation score in patients with MetS. Further studies are needed to confirm the veracity of our results.
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