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reference
Tutunchi H, Arefhosseini S, Ebrahimi-Mameghani M. Clinical efficacy of dietary supplementation with α-lipoic acid, myo-inositol and **propolis on metabolic profiles and liver function in obese patients with NAFLD: a randomized controlled clinical trial.Clin Nutr ESPEN. 2023;54:412-420.
Study objective
Comparison of the Effects of Nutritional Recommendations Together With Alpha-Lipoic Acid (ALA), Myo-Inositol (MI) or Propolis Supplementation on Metabolic Parameters and Liver Function in Obese Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
Key to take away
A calorie-restricted diet leading to weight loss in obese patients appears to be the most effective approach for NAFLD treatment and metabolic parameters, followed by myoinositol and then alpha-lipoic acid to improve liver steatosis.
design
Double-blind, placebo-controlled, randomized clinical trial
Participant
The study was conducted in Iran on 100 male and female obese patients (aged 18–50 years) with low or moderate physical activity and a body mass index (BMI) of at least 30 kg/m2with NAFLD confirmed by fasting ultrasound. Steatosis was classified as mild (grade 1), moderate (grade 2), and severe (grade 3). The researchers excluded pregnant patients; breastfeeding; postmenopausal; smokers; alcohol drinkers; following weight loss diets; taking dietary supplements, antidiabetic drugs, lipid-lowering drugs, contraceptives or medications that affect liver function and enzymes; or who had chronic or acute liver or metabolic diseases.
Interventions
Researchers randomly assigned participants with NAFLD to one of four groups:
- Alpha-Liponsäure (n=21), erhielt 1.200 mg ALA + Placebo,
- Myo-Inositol (n=23), erhielt 4 g MI-Pulver + Placebo,
- Propolis-Gruppe (n=24), die 1.500 mg iranisches Propolis + Placebo erhielt, und
- Kontrollgruppe, die ein Placebo erhielt.
All groups received nutritional recommendations for a calorie-restricted diet prepared by a nutritionist. Researchers determined each participant's individual energy needs and the prescribed low-calorie diet was considered a 500-kcal deficit. The distribution of macronutrients was as follows: fat, 25% to 30% of total energy expenditure; Protein 10% to 15%; and carbohydrates account for 55 to 60% of total energy expenditure. Based on these calculations, meal plans were prepared according to the food-based dietary guidelines for Iranians. The duration of the intervention was 8 weeks.
Evaluated study parameters
Body weight (in kilograms) and height in a fasting state as well as waist and hip circumference were measured. BMI, waist-to-hip ratio and waist-to-height ratio were assessed. In addition, fasting blood samples consisting of glucose, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), serum insulin and homeostasis model were collected at the beginning and end of the study Insulin resistance (HOMA-IR), which was calculated as fasting insulin x fasting glucose/405. Liver enzymes including alanine aminotransferase (ALT) and aspartate transaminase (AST) were included.
Primary outcome
Comparison of the effects of ALA, MI and propolis supplementation and caloric deficit on metabolic parameters and liver function in obese patients with NAFLD.
Key findings
After 8 weeks, all anthropometric measurements decreased significantly in all groups except waist to hip. While the greatest improvement in glycemic index was observed in the MI group (P<0.05), the difference between the groups was not significant. The control group showed the greatest decrease in serum triglycerides (P=0.026), but the MI group showed the greatest improvements in serum total cholesterol, HDL-C, and LDL-C levels (P=0.043,P=0.019 and P=0.041). All groups showed a significant reduction in ALT levels, particularly in the propolis group (P=0.012). AST levels were most reduced in the control group; However, the difference between the groups was “statistically marginal” (P=0.058).
The estimated number needed to treat (NNT) for a one-degree reduction in hepatic steatosis for the MI, ALA, and propolis supplementation groups compared to the control group was 1.5, 2.2, and 3, respectively.
transparency
The study was funded by the Research Vice Chancellor of Tabriz Medical University, Tabriz, Iran. The authors declare that they have no competing financial interests or personal relationships that could have appeared to influence the work reported in this article.
Implications and limitations for practice
Nonalcoholic fatty liver disease is the most common liver disease worldwide and the leading cause of liver-related morbidity and mortality.1
The incidence of NAFLD is increasing alarmingly and the global prevalence is estimated at 32.4%.1NAFLD incidence has been predicted to increase by up to 56% worldwide by 2030.2
NAFLD has metabolic, genetic, epigenetic and environmental risk factors.3Metabolic risk factors for NAFLD include overweight or obesity, insulin resistance or type 2 diabetes, high triglycerides, high total cholesterol, high LDL and/or low HDL, or metabolic syndrome.4
In recent years, NAFLD has emerged as a biological biomarker of social wealth and sedentary lifestyle.3High fructose diet5and increased consumption of carbohydrates, animal proteins and refined sugars as well as smoking, air pollution and low physical activity,3everyone contributes. The complex interactions between environmental factors, metabolism, genetic variants and gut microbiota are thought to be involved in the pathogenesis of NALFD.6
Nonalcoholic fatty liver disease is the most common liver disease worldwide and the leading cause of liver-related morbidity and mortality.
International guidelines for the treatment of NAFLD typically include weight loss and exercise, which have already been shown to improve serum liver enzymes, liver inflammation and fibrosis.7A Mediterranean-style hypocaloric diet has shown improvements in intrahepatic lipid content as well as reductions in transaminases.8
This study examined a caloric deficit in all groups and then compared a control group with alpha-lipoic acid, myo-inositol, and propolis interventions on metabolic parameters associated with NAFLD. The rationale for including the selected additions is as follows:
-
ALA is a cofactor for mitochondrial enzymes and has been shown to improve insulin resistance.9and lower BMI.10ALA regulates the secretion of adipokines, which are associated with the development of NAFLD.11
- MI ist ein Zuckeralkohol mit 6 Kohlenstoffatomen, der endogen produziert wird und in Gemüse, Obst, Hülsenfrüchten, Nüssen und Milch vorkommt. Ein MI-Mangel ist bei Tieren mit einer erhöhten Fettleber verbunden.12 Eine Humanstudie zeigte, dass 2 Gramm Inosit pro Tag den Blutzucker, das Insulin, das Gesamt- und HDL-Cholesterin, den BMI und den Taillenumfang nach 12 Monaten bei 80 postmenopausalen Frauen mit metabolischem Syndrom verbesserten.13
- Propolis, eine von Honigbienen gesammelte harzige Substanz, hat nachweislich eine schützende Wirkung auf Lebersteatose und -fibrose bei Patienten mit NAFLD.14
The study results examined here are relevant for physicians because patients often hope to take a nutritional supplement for diseases such as NAFLD. However, calorie restriction resulting in weight loss over a period of 8 weeks has the greatest impact on NAFLD management and metabolic parameters compared to nutritional supplements. It may also be prudent to consider an MI to improve liver steatosis, followed by an ALA.
Limitations include a relatively short study interval of 8 weeks, which may not have been long enough to see the full effect of the interventions, and a diet that is still relatively high in carbohydrates at 55% to 60%. A low-carb diet may have provided additional benefits.