The age of the participants at the beginning of the study was 51.1 (9.8) years in the AHA group and 49.2 (8.9) years in the FLiO group (P = .326), while sex distribution was 20 women/28 men in AHA group and 23 women/27 men in FLiO group (P = .666). A total of 40 participants were lost after 2 years of follow-up (Figure 1). No statistical differences were found at baseline evaluation in anthropometry, body composition, general biochemical determinations (Table 1), hepatic parameters (Table 2) or macronutrient intake (Table 3) between the two groups of intervention. A total of 12 (12.2%) participants had type 2 diabetes mellitus at the baseline evaluation without significant differences between groups (AHA group n = 8 and FLiO group n = 4; P = .191). The changes in the use of antidiabetic medication were negligible during the study. Likewise, 22 (22.5%) participants had hypertension at the beginning of the study without statistical differences between the groups (AHA group n = 13 and FLiO group n = 9; P = .281). Baseline characteristics were similar between those participants who completed the trial and those who did not (Table S1).
Both the AHA and FLiO groups achieved significant weight reductions at 6 (−9.7% vs −10.1%), 12 (−6.7% vs −9.6%) and 24 months (−4.8% vs −7.6%) without significant differences between them (Figure 2). Similarly, when weight loss percentage was categorized (<3%, 3%-5%, and >5%) no significant differences between the dietary groups were found, although the FLiO group showed a marginally greater proportion of participants with a weight loss of >5% at 24 months compared to the AHA group (Table S2).
Comparison of weight loss (%) between AHA and FLiO groups at different timepoints of the study. Data were presented as mean (SEM). AHA, American Heart Association; FLiO, Fatty Liver in Obesity
Significant improvements in anthropometry, body composition and biochemical parameters were observed along the study in both dietary groups (Table 1). Notably, both groups maintained the reductions in glucose, insulin, HOMA-IR and leptin during the follow-up of the study, without significant differences between the changes in AHA and FLiO diets. Meanwhile, AHA but not FLiO group maintained a reduction in systolic blood pressure at 24 months compared to baseline values. However, the FLiO group exhibited significantly greater reductions in triglycerides (P = .045), TyG (P = .008) and AIP (P = .009) at 12 months, and in waist circumference (P = .028), TyG (P = .021) and AIP (P = .019) at 24 months, compared to AHA group. Regarding adiponectin, significant increases within dietary groups were observed along the study, but the change was significantly greater in the FLiO group than in the AHA group at 6 (P = .034) and 24 months (P = .008). When the analyses of the differences between groups were adjusted by weight loss percentage at each timepoint of the study, the FLiO group maintained the significantly greater decrease in TyG at 12 months (P = .049) and the significantly greater increase in adiponectin at 24 months (P = .019) compared to the AHA group.
Regarding hepatic assessment, both groups showed significant improvements in the follow-up evaluations of the trial (Table 2). Notably, both groups maintained the reductions in steatosis degree, FLI, and HSI along the study. However, the FLiO group maintained a significant decrease in ALT (P < .001), liver fat (P < .01) and TE liver stiffness (P < .05) at 24 months compared to baseline values, while no significant changes were observed within the AHA group in the same parameters after the 24-month follow-up. Moreover, the FLiO group showed a significantly greater decrease in ARFI liver stiffness (P = .039) at 6 months, AST (P = .034) and FLI (P = .008) at 12 months, and ALT (P = .038), TE liver stiffness (P = .016), and FLI (P = .021) at 24 months compared to the AHA group. In addition, significantly lower values of AST and FLI at 12 months, and liver fat and liver stiffness at 24 months were observed in the FLiO group compared to the AHA group (Figure 3). Nevertheless, the statistical differences in hepatic parameters between the AHA and FLiO group disappeared when the analyses were adjusted by the percentage of weight loss in each group at the different timepoints of the study.
Comparison of liver status parameters between AHA and FLiO group at each timepoint of the study. Data were presented as mean (SEM). AHA, American Heart Association; ALT, Alanine aminotransferase; AST, Aspartate aminotransferase; FLI, Fatty Liver Index; FLiO, Fatty Liver in Obesity; HSI, Hepatic Steatosis Index
Additionally, the severity of fibrosis was categorized according to the values of TE at all the evaluations of the study (Table S3) and the number of participants with advanced fibrosis was determined (Table S4). Only five participants in the AHA group and two in the FLiO group had advanced fibrosis at the beginning of the study without significant differences between the groups (P = .202). Similarly, no significant differences between the AHA and the FLiO group in the frequencies of advanced fibrosis were observed in the follow-up evaluations (6 months P = .300; 12 months P = .321; 24 months P = .188).
Dietary evaluation (Table 3) showed expected differences between the AHA and FLiO groups regarding the changes in carbohydrate and protein intake at 6 and 12 months of the study, although these differences were attenuated at 24 months. The increase in the reported intake of polyunsaturated fatty acids (PUFA) was significantly greater in the FLiO group compared to the AHA group at all the follow-up visits of the study (6 months P < .001; 12 months P < .001; 24 months P = .002), while the reduction in the consumption of saturated fatty acids (SFA) was significantly greater in the FLiO group at 24 months (P = .019). Notably, the MedDiet adherence significantly increased in both groups at the different timepoints of the study and this change was significantly greater in the FLiO group at 6 months (P = .003) and marginally greater at 12 months (P = .052) compared to the AHA group. On the other hand, the AHA group showed significant increases in physical activity at all the follow-up visits of the study compared to baseline values, while the FLiO group only increased physical activity at 6 months. However, the changes in physical activity did not reveal statistical differences between the groups.
Liver International. 2021;41(7):1532-1544. © 2021 Blackwell Publishing