Soy Milk for Non-alcoholic Fatty Liver Disease
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Marialena Mouzaki
Disqualifiers: Soy allergy, Cow's milk allergy, Recent antibiotics, Endocrine disorders, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?A randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities. The investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are being treated for existing endocrine disorders, you may not be eligible to participate.
What data supports the effectiveness of soy milk as a treatment for non-alcoholic fatty liver disease?
Research suggests that soy milk and its components, like soy isoflavones, may help improve liver health in non-alcoholic fatty liver disease by enhancing metabolic parameters and reducing liver fat. Studies in both animals and humans have shown that soy can positively affect liver function and reduce oxidative stress, which is beneficial for managing this condition.
12345Is soy milk safe for humans?
The studies reviewed do not report any specific safety concerns about soy milk or soy isoflavones in humans, suggesting it is generally safe for consumption.
12346How does soy milk treatment differ from other treatments for non-alcoholic fatty liver disease?
Soy milk is unique for non-alcoholic fatty liver disease because it contains soy isoflavones, which have been shown to improve metabolic parameters and reduce liver fat accumulation through natural pathways, unlike other treatments that may not focus on dietary components.
12467Eligibility Criteria
This trial is for children with non-alcoholic fatty liver disease (NAFLD) who are overweight or obese. They must have an MRI PDFF >10% and elevated ALT levels (>22 for females, >26 for males).Inclusion Criteria
I have NAFLD or my ALT levels are high for my sex.
I have NAFLD with a liver fat level over 10% on MRI.
My child is overweight or obese.
Exclusion Criteria
Baseline habitual (>3 days per week) consumption of soy foods
I have taken antibiotics in the last 8 weeks.
MRI-PDFF <10%
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants consume either standard soy milk or 2% fat cow's milk twice daily
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study compares the effects of drinking standard soy milk versus 2% fat cow's milk on the severity of NAFLD in children. It aims to see if soy isoflavones in soy milk can help reduce liver disease.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard Soy MilkExperimental Treatment1 Intervention
Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks.
Group II: 2% Fat Cows MilkPlacebo Group1 Intervention
Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cincinnati Children's Hospital Medical CenterCincinnati, OH
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Who Is Running the Clinical Trial?
Marialena MouzakiLead Sponsor
References
Effect of Soy Milk on Metabolic Status of Patients with Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. [2020]Studies in experimental models of nonalcoholic fatty liver disease (NAFLD) have reported positive effects of soy components in improving metabolic parameters. Whether such effects could be achieved through consumption of whole soy foods in patients with NAFLD is still unclear. Therefore, this trial was conducted to assess the effects of soy milk on metabolic parameters of patients with NAFLD.
Effect of soy milk consumption on glycemic status, blood pressure, fibrinogen and malondialdehyde in patients with non-alcoholic fatty liver disease: a randomized controlled trial. [2019]Diet plays a critical role in the management of non-alcoholic fatty liver disease (NAFLD). Studies on the NAFLD's experimental models have reported that soy had positive effects on the improvement of metabolic parameters. However, there is a lack of clinical trials regarding the efficacy of whole soy foods. Therefore, this study was conducted to determine the effect of soy milk on some of the metabolic characteristics in patients with NAFLD.
Soy diet for nonalcoholic fatty liver disease: A meta-analysis of randomized controlled trials. [2023]The efficacy of soy diet for nonalcoholic fatty liver disease remains controversial. We conduct a systematic review and meta-analysis to explore the influence of soy diet vs placebo on the treatment of non-alcoholic fatty liver disease.
Diet Containing Soy Protein Concentrate With Low and High Isoflavones for 9 Weeks Protects Against Non-alcoholic Fatty Liver Steatosis Using Obese Zucker Rats. [2022]Non-alcoholic fatty liver disease (NAFLD), is one of the main liver diseases in the US and the world which often is related to obesity. Previously, we reported short- and long-term consumption of soy protein isolate diet with high isoflavones can reduce liver steatosis in the male and female obese Zucker rat model. However, the effects of high vs. low soy isoflavones on NAFLD is less known. The objectives of the present study were to examine the role of isoflavones levels in soy protein concentrate diets on protection against NAFLD in an obese rat model. Forty-two 6-week old lean (L, n = 21) and obese (O, n = 21) Zucker rats were randomly assigned to 1 of 3 dietary groups: casein diet (C = control), soy protein concentrate with low isoflavones (LIF), or soy protein concentrate with high isoflavones (HIF) for 9 weeks. Rats were weighed twice weekly. After 9 weeks, rats were sacrificed and samples of livers were taken for histopathological analysis. Serums were collected to measure ALT and AST levels. Results indicate that obese rats gained significantly more weight than lean rats for all three diet groups (P < 0.001). No significant difference in body weight between LC, LLIF and LHIF was noted. However, the OLIF and OHIF rats gained significantly more weight than OC rats (P < 0.001). Liver steatosis scores were significantly greater in obese rats compared to lean rats (P < 0.001). The OLIF and OHIF-fed rats had significantly reduced steatosis scores than OC rats (P = 0.013 and P < 0.001, respectively). The serum ALT levels were significantly greater in OC, OLIF and OHIF compared to LC, LLIF and LHIF, respectively (P < 0.001, P < 0.001, and P = 0.011). AST serum levels were greater in OC and OLIF compared to LC and LLIF, respectively (P = 0.001 and P = 0.022). In summary, we found that soy protein concentrate with isoflavones protects against liver steatosis and the protection is greater with a higher concentration of isoflavones.
Preclinical and clinical evidence for the treatment of non-alcoholic fatty liver disease with soybean: A systematic review and meta-analysis. [2023]Non-alcoholic fatty liver disease (NAFLD), a prevalent public health issue, involves the accumulation of triglycerides in hepatocytes, which is generally considered to be an early lesion of liver fibrosis and cirrhosis. Thus, the development of treatments for NAFLD is urgently needed. This study explored the preclinical and clinical evidence of soybeans to alleviate NAFLD. Studies indexed in three relevant databases-Web of Science, PubMed, and Embase-between January 2002 and August 2022 were retrieved. A total of 13 preclinical studies and five RCTs that included 212 animals and 260 patients were included in the present analysis. The preclinical analysis showed that liver function indices (AST, SMD = -1.41, p < 0.0001 and ALT, SMD = -1.47, p < 0.0001) were significantly improved in the soybean group compared to the model group, and fatty liver indicators (TG, SMD = -0.78, p < 0.0001; TC, SMD = -1.38, p < 0.0001) and that oxidative stress indices (MDA, SMD = -1.09, p < 0.0001; SOD, SMD = 1.74, p = 0.022) were improved in the soybean group. However, the five RCTs were not entirely consistent with the preclinical results; however, the results confirmed the protective effect on the liver. The results of the clinical RCTs showed that soybean significantly affected liver function, fatty liver, and oxidative stress indicators (ALT, SMD = -0.42, p = 0.006; TG, SMD = -0.31, p = 0.039; MDA, SMD = -0.76, p = 0.007). The current meta-analysis combined preclinical and clinical studies and verified that soybean could protect the liver in NAFLD by regulating lipid metabolism and oxidative stress factors via the Akt/AMPK/PPARα signaling pathway. Soybean might be a promising therapeutic agent for treating non-alcoholic fatty liver disease. Systematic Review Registration: (https://www.crd.york.ac.uk/prospero/#myprospero), identifier (CRD42022335822).
Isoflavones as a smart curer for non-alcoholic fatty liver disease and pathological adiposity via ChREBP and Wnt signaling. [2023]Non-alcoholic fatty liver disease (NAFLD) and pathological adiposity has emerged as an important modern disease. Along with this, the requirement for alternative and natural medicine for preventing NAFLD and adiposity has been increasing rapidly and considerably. In this report, we will review the biological effect and mechanisms of soy isoflavones on NAFLD and pathologic adiposity mainly through the novel pathways, de novo lipogenic carbohydrate responsive element binding protein (ChREBP) and anti-adipogenic Wnt signaling.
Hypolipidemic Effects of Soy Protein and Isoflavones in the Prevention of Non-Alcoholic Fatty Liver Disease- A Review. [2022]Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease and affects about 25% of the population globally. Obesity and diabetes are the main causes of the disease characterized by excessive accumulation of lipids in the liver. There is currently no direct pharmacological treatments for NAFLD. Dietary intervention and lifestyle modification are the key strategies in the prevention and treatment of the disease. Soy consumption is associated with many health benefits such as decreased incidence of coronary heart disease, type-2 diabetes, atherosclerosis and obesity. The hypolipidemic functions of soy components have been shown in both animal studies and human clinical trials. Dietary soy proteins and associated isoflavones suppressed the formation and accumulation of lipid droplets in the liver and improved NAFLD-associated metabolic syndrome. The molecular mechanism(s) underlying the effects of soy components are mainly through modulation of transcription factors, sterol regulatory element-binding protein-1 and peroxisome proliferator-activated receptor-γ2, and expressions of their target genes involved in lipogenesis and lipolysis as well as lipid droplet-promoting protein, fat-specific protein-27. Inclusion of appropriate amounts of soy protein and isoflavones in the diets might be a useful approach to decrease the prevalence of NAFLD and mitigate disease burden.