A Khorasan Wheat-Based Replacement Diet Improves Risk Profile of Patients With Nonalcoholic Fatty Liver Disease (NAFLD): A Randomized Clinical Trial.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
replacement diet with ancient khorasan wheat products | decrease | alanine aminotransferase (ALT) | patients with NAFLD | 12% | significantly reduced | #1 |
replacement diet with ancient khorasan wheat products | decrease | aspartate aminotransferase (AST) | patients with NAFLD | 14% | significantly reduced | #2 |
replacement diet with ancient khorasan wheat products | decrease | alkaline phosphatase (ALP) | patients with NAFLD | 8% | significantly reduced | #3 |
replacement diet with ancient khorasan wheat products | decrease | cholesterol | patients with NAFLD | 6% | significantly reduced | #4 |
replacement diet with ancient khorasan wheat products | decrease | circulating proinflammatory tumor necrosis factor-alpha | patients with NAFLD | 50% | significant reductions | #5 |
replacement diet with ancient khorasan wheat products | decrease | interleukin l-receptor antagonist-alpha | patients with NAFLD | 37% | significant reductions | #6 |
replacement diet with ancient khorasan wheat products | decrease | interleukin-8 | patients with NAFLD | 24% | significant reductions | #7 |
replacement diet with ancient khorasan wheat products | decrease | interferon gamma | patients with NAFLD | 24% | significant reductions | #8 |
replacement diet with ancient khorasan wheat products | decrease | liver steatosis grading | patients with NAFLD | - | significant improvements | #9 |
replacement diet with ancient khorasan wheat products | increase | Doppler perfusion index values | patients with NAFLD | - | significant improvements | #10 |
replacement diet with ancient khorasan wheat products | decrease | reactive oxygen species (ROS) production | patients with NAFLD | - | significant improvements | #11 |
replacement diet with control products made from organic semi-whole-grain modern wheat | decrease | liver steatosis grading | patients with NAFLD | - | significant improvements | #12 |
replacement diet with control products made from organic semi-whole-grain modern wheat | increase | Doppler perfusion index values | patients with NAFLD | - | significant improvements | #13 |
replacement diet with control products made from organic semi-whole-grain modern wheat | decrease | reactive oxygen species (ROS) production | patients with NAFLD | - | significant improvements | #14 |
OBJECTIVE: KAMUT khorasan is an ancient grain with widely acclaimed health benefits. The aim of this study was to investigate the effects of a replacement diet with ancient khorasan wheat products in patients with NAFLD, in comparison to a similar replacement diet with control products made from organic semi-whole-grain modern wheat. METHODS: Forty NAFLD patients (12 M/28 F; age 55.2 ± 10.4 years) with mild to moderate liver steatosis were included. The experimental design was a randomized, double-blind, parallel-arm study with 20 participants assigned to consume either KAMUT khorasan or control wheat products (pasta, bread, crackers, biscuits) over a 3-month period. Anthropometric measurements, blood analyses, and ultrasonography examination were performed at both the beginning and end of each dietary intervention. RESULTS: After the implementation of a general linear model for repeated measurements adjusted for baseline demographic details, risk factors, and medication, alanine aminotransferase (ALT) was significantly reduced by 12%, aspartate aminotransferase (AST) by 14%, alkaline phosphatase (ALP) by 8%, and cholesterol by 6% only in the khorasan group (p < 0.05 for all). Similarly, significant reductions in circulating proinflammatory tumor necrosis factor-alpha by 50%, interleukin l-receptor antagonist-alpha by 37%, interleukin-8 by 24%, and interferon gamma by 24% were evident only in participants who consumed the khorasan products (p < 0.05 for all). Finally, significant improvements in the liver steatosis grading, Doppler perfusion index values, and reactive oxygen species (ROS) production were evident after consumption of both the khorasan and control products. CONCLUSIONS: This study suggests that a short-term replacement diet with ancient KAMUT khorasan products is most effective in reducing metabolic risk factors and ameliorating the liver profile in patients with NAFLD.