Amino Acid Supplementation for Kidney Disease
(OASIS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: The University of Texas Health Science Center at San Antonio
Must not be taking: Amino acids, Antidepressants
Disqualifiers: COVID-19, Alcohol, Cancer, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The study will test and compare the efficacy of a single essential amino acid valine with a combination of essential amino acids (EAA) supplement on fatigue, frailty, and cognitive function in end-stage kidney disease (ESKD) patients undergoing hemodialysis (HD) treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking amino acid supplements, antidepressants for major depressive disorder, or receiving active management for heart failure or anticancer therapy.
What data supports the effectiveness of the treatment Essential Amino Acids for kidney disease?
Research shows that essential amino acids (EAA) can improve nutritional status and slow the progression of chronic kidney disease. In patients on hemodialysis, EAA supplementation led to clinical improvements such as increased body weight and better appetite.
12345Is amino acid supplementation safe for people with kidney disease?
Research suggests that essential amino acid and ketoacid supplements are generally safe for people with kidney disease, as they can improve nutritional status and may help maintain kidney function without causing significant side effects.
12367How does the treatment with essential amino acids and valine differ from other treatments for kidney disease?
This treatment is unique because it uses essential amino acids (EAAs) and their keto analogues (KAs) to support kidney function without adding extra nitrogen, which can be harmful in kidney disease. It helps maintain good nutrition and may delay the need for dialysis by reducing toxic metabolic products and managing mineral levels like potassium and phosphorus.
13467Eligibility Criteria
This trial is for men and women aged 18-64 who have end-stage kidney disease and have been receiving in-clinic hemodialysis three times a week for at least six months. It's not specified who can't join, but typically those with other serious health issues or conditions that could interfere with the study might be excluded.Inclusion Criteria
I am either male or female.
I am between 18 and 64 years old.
I have been on hemodialysis 3 times a week for at least 6 months.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either EAA or Valine supplementation on dialysis treatment days, followed by a washout period and crossover to the other supplement
17 weeks
3 visits per week (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study aims to see if taking the amino acid valine alone or a mix of essential amino acids (EEA) can help reduce fatigue, frailty, and improve thinking skills in patients on hemodialysis due to severe kidney disease.
2Treatment groups
Experimental Treatment
Group I: Treatment group Valine then EEAExperimental Treatment2 Interventions
Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA
Group II: Treatment group EEA then ValineExperimental Treatment2 Interventions
EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine
Essential Amino Acids is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Essential Amino Acids for:
- Nutritional deficiencies
- Malnutrition
- Wound healing
🇪🇺 Approved in European Union as Essential Amino Acids for:
- Nutritional deficiencies
- Malnutrition
- Wound healing
- Parenteral nutrition
🇨🇦 Approved in Canada as Essential Amino Acids for:
- Nutritional deficiencies
- Malnutrition
- Wound healing
🇯🇵 Approved in Japan as Essential Amino Acids for:
- Nutritional deficiencies
- Malnutrition
- Wound healing
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at San AntonioSan Antonio, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
National Center for Advancing Translational Sciences (NCATS)Collaborator
IIMS-UT Health San AntonioCollaborator
References
Ketoacids in the treatment of uremia. [2013]Essential amino acid supplementation (EAA) was compared with supplementation by a mixture (KA) of keto-analogues of valine, leucine, isoleucine, methionine and phenylalanine, plus the four remaining essential amino acids in stable chronic uremics. When KA were given after EAA, urea appearance fell and N balance improved (9 studies). When EAA were given after KA (5 studies), urea appearance and N balance did not worsen significantly during the 4-9 days of observation. Seven patients, including one on chronic dialysis prior to therapy, were given KA for 3-9 months as outpatients. In three, renal function clearly improved. Five became asymptomatic for intervals of 3-8 months.
[The parenteral administration of essential amino acids in patients on periodic hemodialysis treatment. A pilot study]. [2007]In an attempt to improve the nutritional status of seven hemodialysed patients, 500 ml of a 5.5% nephrological essential amino acid solution (EAA) were administered during each dialysis session for 2 months. At the end of this treatment, a significant increase in albuminemia was found (p
The influence of two different essential amino acid/keto analogue preparations on the clinical status of patients with chronic renal failure. [2019]58 outpatients with a serum creatinine between 6-10 mg/dl received a low protein diet (LPD) with 30 g protein/day, supplemented with essential amino acids (EAA) or their keto analogues (KA). Group A (n = 19) was given an EAA/KA supplement according to the pattern proposed by Rose and group B (n = 39) received a preparation with an increased amount of KAs of branched chain amino acids (BCKA), as recommended by Walser. At the start of treatment with a LPD supplemented with either of the two supplements and after 6 months of treatment we assessed: plasma branched chain amino acids (BCAA), renal function, nutritional status, and bone metabolism. After six months of dietary treatment the results showed in group B in contrast to group A an improvement of nutritional status (body weight increased, urea decreased, and BCAA normalized). The same was true for bone metabolism (significantly lower phosphate levels, increased calcium values). In both groups progression of chronic renal failure slowed down, but the delay was more pronounced in group B. All results were statistically significant (p less than 0.01).
A controlled study of supplementation with essential amino acids and alpha-keto acids in the conservative management of patients with chronic renal failure. [2019]Oral therapy with essential amino acids (EAA) or alpha-keto acids (alpha-KA) has been recommended in patients with renal failure, but quality and quantity of optimal protein intake are still controversial. This study compares sequentially the effect of supplementation with EAA, and with alpha-KA versus placebo in 15 ambulatory patients with chronic renal failure (average creatinine clearance 10.8 ml/min), maintained on a protein diet of 0.57 g/kg body weight (40 g for a 70-kg patient). The actual dietary intake averaged 0.55 g protein/kg and 27 kcal/kg according to repeated 7-day dietary recordings. After a 6-week baseline period on this diet, all patients received additionally 0.112 g EAA/kg for 6 weeks followed by a double-blind crossover study of 0.105 g alpha-KA/kg versus placebo supplementation for 6 weeks each. Fasting blood samples for multiple parameters, including 15 indicators for protein deficiency, as well as anthropometric and clinical data were evaluated every 3 weeks. Laboratory data revealed no indications of protein deficiency. Therapy with alpha-KA diminished serum phosphate concentration (p less than 0.05), however no other significant beneficial effects could be demonstrated during supplementation with either EAA or alpha-KA. Therefore, such supplementation to a 0.55-g/kg-protein diet appears superfluous in stable ambulatory patients with renal insufficiency.
The use of oral essential amino acids in hemodialysis patients. [2004]Fifteen patients with chronic renal failure, stabilized on twice weekly hemodialysis, received oral essential amino acid therapy (6.3 g/day) over a period of 12.3 months. Clinical and laboratory improvement was observed with respect to body weight, tricep skin fold thickness, mid upper arm circumference serum albumin, C3 and plasma essential amino acids. Serum triglyceride was decreased. The patients felt well with increased appetite. Essential amino acids were well tolerated without side effects.
Is there a role for ketoacid supplements in the management of CKD? [2022]Ketoacid (KA) analogues of essential amino acids (EAAs) provide several potential advantages for people with advanced chronic kidney disease (CKD). Because KAs lack the amino group bound to the α carbon of an amino acid, they can be converted to their respective amino acids without providing additional nitrogen. It has been well established that a diet with 0.3 to 0.4 g of protein per kilogram per day that is supplemented with KAs and EAAs reduces the generation of potentially toxic metabolic products, as well as the burden of potassium, phosphorus, and possibly sodium, while still providing calcium. These KA/EAA-supplemented very-low-protein diets (VLPDs) can maintain good nutrition, but the appropriate dose of the KA/EAA supplement has not been established. Thus, a KA/EAA dose-response study for good nutrition clearly is needed. Similarly, the composition of the KA/EAA supplement needs to be reexamined; for example, some KA/EAA preparations contain neither the EAA phenylalanine nor its analogue. Indications concerning when to inaugurate a KA/EAA-supplemented VLPD therapy also are unclear. Evidence strongly suggests that these diets can delay the need for maintenance dialysis therapy, but whether they slow the loss of glomerular filtration rate in patients with CKD is less clear, particularly in this era of more vigorous blood pressure control and use of angiotensin/aldosterone blockade. Some clinicians prescribe KA/EAA supplements for patients with CKD or treated with maintenance dialysis, but with diets that have much higher protein levels than the VLPDs in which these supplements have been studied. More research is needed to examine the effectiveness of KA/EAA supplements with higher protein intakes.
Controlled trial of two keto acid supplements on renal function, nutritional status, and bone metabolism in uremic patients. [2007]In this matched, controlled study, two different types of EAA/KA supplements were compared in uremic patients fed a 30 g protein restricted diet. The patients were paired for age, sex, and underlying renal disease. The supplement with the higher BCKA content resulted in an improvement of renal function, bone metabolism, and a normalization of plasma BCAA concentrations. With both supplements, adequate nutritional status of the patients was maintained. We conclude that the BCKA content of the supplement is of considerable importance for uremic patients on low protein diets.