Amino Acids for Fatty Liver Disease
(AMINOS Trial)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Colorado, Denver
Must not be taking: Metformin, Glucocorticoids, Antipsychotics, others
Disqualifiers: Pregnancy, Diabetes, Anemia, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Participants 13-18 years of age with extra fat stored in the liver will be randomly assigned to a protein supplement or placebo "fake supplement" for 2 months to see if the participants who get the protein supplement have less fat in the liver compared to participants who were in the placebo group. After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.
Will I have to stop taking my current medications?
The trial requires that you do not take certain medications that affect insulin sensitivity, like metformin, or blood pressure medications. If you are on these, you may need to stop them to participate.
What data supports the effectiveness of the treatment Essential Amino Acid Supplement by Amino Co for fatty liver disease?
Research on a combination of amino acids similar to those in the supplement showed potential benefits in treating nonalcoholic steatohepatitis (a severe form of fatty liver disease) by impacting metabolism, inflammation, and fibrosis in cell models. This suggests that specific amino acid combinations might help manage fatty liver disease.
12345Is the Essential Amino Acid Supplement safe for humans?
Research on branched-chain amino acids (BCAAs), a type of amino acid supplement, shows they do not cause adverse effects in patients with liver conditions, suggesting they are generally safe for human use.
35678How is the Essential Amino Acid Supplement treatment different from other treatments for fatty liver disease?
The Essential Amino Acid Supplement by Amino Co is unique because it uses a specific combination of amino acids that target multiple aspects of nonalcoholic steatohepatitis (NASH), including metabolism, inflammation, and fibrosis, which are core features of the disease. This multitargeted approach is different from other treatments that may focus on only one aspect of the condition.
358910Eligibility Criteria
Adolescents aged 13-18 with fatty liver disease, specifically non-alcoholic fatty liver disease (NAFLD), who are overweight and do not exercise much. They must have a confirmed diagnosis by biopsy and be in the later stages of puberty. Those who are very active or don't meet the specific medical criteria cannot join.Inclusion Criteria
Sedentary- less than 3 hours of moderate (jogging, swimming, etc.) exercise a week
I am between 13 and 18 years old and have advanced in puberty.
My BMI is in the overweight or obese range for my age and gender.
+2 more
Exclusion Criteria
Implanted metal devices that are not compatible with MRI
I am taking medication for high blood pressure.
Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomly assigned to receive either a protein supplement or placebo for 2 months
8 weeks
2 visits (in-person) for MRI, body x-ray, and blood draw
Open-label extension
All participants receive the protein supplement for an additional 10 months
10 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing if an essential amino acid supplement can reduce liver fat in teens with NAFLD compared to a placebo over two months. After this period, all participants will receive the actual supplement for ten more months.
2Treatment groups
Active Control
Placebo Group
Group I: Amino Acid SupplementActive Control1 Intervention
Participants are blindly randomized and for this arm, participants will take the Essential Amino Acid Supplement for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants
Group II: PlaceboPlacebo Group1 Intervention
Participants are blindly randomized and for this arm, participants will take the Placebo for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants
Essential Amino Acid Supplement by Amino Co is already approved in United States for the following indications:
🇺🇸 Approved in United States as Essential Amino Acid Supplement for:
- Nutritional supplement for general health and wellness
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Univeristy of Colorado Anschutz Medical CampusAurora, CO
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Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Pancrelipase with branched-chain amino acids for preventing nonalcoholic fatty liver disease after pancreaticoduodenectomy. [2019]To investigate the efficacy of the early administration of pancreatic enzymes combined with an elemental diet of branched-chain amino acids (BCAA) for nonalcoholic fatty liver disease (NAFLD) after pancreaticoduodenectomy (PD).
Controlled trial of nutritional supplementation, with and without branched chain amino acid enrichment, in treatment of acute alcoholic hepatitis. [2022]Sixty-four patients admitted with acute alcoholic hepatitis, with or without underlying cirrhosis, were randomized regardless of encephalopathy to receive a controlled diet either alone, or supplemented orally, nasogastrically, or intravenously as necessary, with 2000 kCal and 10 g nitrogen daily. Whether this came from a conventional protein source or a branched chain amino acid enriched formulation was also randomly determined. In the absence of renal failure, nitrogen intakes of 10 g or more daily were invariably associated with positive nitrogen balance, but complications of liver dysfunction prevented the attainment of significantly more positive balance in the supplemented groups than in controls. Neither in the series as a whole, nor in any identifiable subgroup of patients, was mortality affected by treatment. Changes in prothrombin time and in measured nutritional parameters during the study did not differ between supplemented and control groups, and the observed changes in midarm muscle circumference appeared to reflect changes in degree of fluid retention. Neither enteral nor parenteral branched chain amino acids showed any consistent effect upon encephalopathy.
A novel, multitargeted endogenous metabolic modulator composition impacts metabolism, inflammation, and fibrosis in nonalcoholic steatohepatitis-relevant primary human cell models. [2021]Nonalcoholic steatohepatitis (NASH) is a complex metabolic disease of heterogeneous and multifactorial pathogenesis that may benefit from coordinated multitargeted interventions. Endogenous metabolic modulators (EMMs) encompass a broad set of molecular families, including amino acids and related metabolites and precursors. EMMs often serve as master regulators and signaling agents for metabolic pathways throughout the body and hold the potential to impact a complex metabolic disease like NASH by targeting a multitude of pathologically relevant biologies. Here, we describe a study of a novel EMM composition comprising five amino acids and an amino acid derivative (Leucine, Isoleucine, Valine, Arginine, Glutamine, and N-acetylcysteine [LIVRQNac]) and its systematic evaluation across multiple NASH-relevant primary human cell model systems, including hepatocytes, macrophages, and stellate cells. In these model systems, LIVRQNac consistently and simultaneously impacted biology associated with all three core pathophysiological features of NASH-metabolic, inflammatory, and fibrotic. Importantly, it was observed that while the individual constituent amino acids in LIVRQNac can impact specific NASH-related phenotypes in select cell systems, the complete combination was necessary to impact the range of disease-associated drivers examined. These findings highlight the potential of specific and potent multitargeted amino acid combinations for the treatment of NASH.
Late evening snack and oral amino acid capsules improved respiratory quotient and Fischer ratio in patients with alcoholic liver cirrhosis. [2023]Appropriate nutritional support may improve energy metabolism in alcoholic liver cirrhosis (ALC) patients. We explored the effect of a late evening snack (LES) and oral amino acid (OAA) capsules on energy metabolism and the Fischer ratio in ALC.
The effect of alpha-lipoic acid on inflammatory markers and body composition in obese patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial. [2019]Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver injury. Some animal studies suggest that alpha-lipoic acid (ALA) can improve disease outcome. The aim of this study was to investigate the effects of ALA supplementation on liver enzymes and inflammatory markers in obese patients with NAFLD.
Effects of Branched-Chain Amino Acid (BCAA) Supplementation on the Progression of Advanced Liver Disease: A Korean Nationwide, Multicenter, Prospective, Observational, Cohort Study. [2021]Clinical evidence for the benefits of branched-chain amino acids (BCAAs) is lacking in advanced liver disease. We evaluated the potential benefits of long-term oral BCAA supplementation in patients with advanced liver disease.
Oral branched-chain amino acids have a beneficial effect on manifestations of hepatic encephalopathy in a systematic review with meta-analyses of randomized controlled trials. [2023]Supplements with branched-chain amino acid (BCAA) have cerebral, metabolic, and nutritional effects that may benefit patients with hepatic encephalopathy (HE). We therefore conducted a systematic review on the effects of oral BCAAs compared with control supplements or placebo for patients with cirrhosis and recurrent overt or minimal HE. The quantitative analyses included data from 8 trials (n = 382 patients). Individual patient data were retrieved from 4 trials to recalculate outcomes (n = 255 patients). The mean dose of the oral BCAA supplements was 0.25 g/(kg body weight · d). Random effects meta-analysis showed that improvements in HE manifestations were registered for 87 of 172 patients in the BCAA group compared with 56 of 210 controls [risk ratio = 1.71 (95% CI: 1.17, 2.51) number needed to treat = 5 patients]. The effect of BCAAs differed (P = 0.04) for patients with overt [risk ratio = 3.26 (95% CI: 1.47, 7.22)] and minimal HE [risk ratio = 1.32 (95% CI: 0.97, 1.79)]. Subgroup, sensitivity, regression, and sequential analyses found no other sources of heterogeneity or bias. BCAA supplements had no effect on mortality or markers of nutritional status and did not induce adverse events. In conclusion, oral BCAA supplements improve manifestations of HE but have no effect on survival.
The association between dietary amino acids and the risk of nonalcoholic fatty liver disease among Tehranian adults: a case-control study. [2023]Amino acids (AAs) are important bioactive components in the diet that can be involved in various underlying biological processes that contribute to the development of nonalcoholic fatty liver disease (NAFLD). The present study investigates the association between dietary intake of amino acids and NAFLD in Iranian adults.
Effect of parenteral amino acid supplementation on short-term and long-term outcomes in severe alcoholic hepatitis: a randomized controlled trial. [2022]The effect of parenteral amino acid administration on nutritional state, liver function and mortality was assessed in patients with severe alcoholic hepatitis. Twenty-eight patients received 2 l/day of a solution of dextrose (65 gm/L) and amino acids (25.8 gm/L) for 1 mo, whereas 26 received only the dextrose solution. All patients were allowed to eat a standard hospital diet. During the month in the hospital, there were six deaths in the treatment group and five deaths in the control group. Nitrogen balance improved in the treated group, but not in the control group. Creatinine-height index, triceps skin fold measurement and levels of serum albumin and prealbumin increased similarly in both groups. Serum retinol binding protein increased more in the treatment group than it did in the control group, and transferrin was increased only in the treatment group. Serum bilirubin, type III amino-terminal procollagen peptide and aminopyrine clearance improved more in the treatment group than in the control group, whereas serum AST and prothrombin time improved in the treatment group but not in the control group. Cumulative 2-yr survival rates from the day of entry into the study were 42% and 38% in the treatment and control groups, respectively. Patients who survived 2 yr and patients in the treatment group who died during the 2-yr follow-up had continued improvement in serum retinol binding protein, transferrin, bilirubin and prothrombin time. These parameters were unchanged in patients in the control group who died during follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)
Tyrosine levels are associated with insulin resistance in patients with nonalcoholic fatty liver disease. [2020]Amino acid imbalance is often found in patients with cirrhosis, and this imbalance is associated with insulin resistance. However, the mechanism underlying the relationship between amino acid imbalance and insulin resistance remains unclear. We evaluated serum amino acid concentrations in patients with nonalcoholic fatty liver disease to determine if any of the levels of amino acids were associated with the biochemical markers and fibrosis stage of nonalcoholic steatohepatitis (NASH).