Oral Branched-chain Amino Acid Supplementation for Decompensated Cirrhotic Patients: a Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Average Compression Index
研究概览
简要总结
The goal of this clinical trial is to compare the nutritional parameters after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL.
The main questions it aims to answer are:
- Would thigh muscle thickness change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL?
- Would triceps skin fold thickness, mid-arm circumferences, mid-arm muscle circumferences, skeletal muscle mass, appendicular skeletal muscle mass, skeletal muscle index and fat mass change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL?
- Would handgrip strength change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL?
- Would serum albumin change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL?
- Would score for cirrhotic severity such as Model for End-Stage Liver Disease-Sodium Score (MELD-Na score) and Child Turcotte Pugh Score change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL?
Participants will be asked to do following tasks:
- Participants will be asked for basic information such as age, place of residence, and contact telephone number.
- Participants will undergo measurements of weight, height, body mass index, skinfold thickness on the arms, circumference of the arms and legs, muscle mass, and body fat content using a body composition analyzer, both at the beginning and end of the research study.
- Participants will perform grip strength measurements, at both the beginning and end of the research study.
- Participants will undergo laboratory tests, including a complete blood count, liver and kidney function tests, blood clotting factors, and blood mineral levels, with a total blood volume of approximately 15 milliliters (1 tablespoon), collected twice during the study (at the beginning and end).
- Participants will be administered supplements containing branched-chain amino acids (BCAA) twice a day for a total of 12 weeks.
- Participants will be appointed for follow-up during the study, totaling 2 appointments at weeks 4 and 12. Side effects related to medication will be asked.
- Participants will undergo ultrasound measurements of the right thigh to assess thigh muscle thickness, both at the beginning and end of the research study.
- Participants will will complete questionnaires to assess your overall quality of life twice, both at the beginning and end of the research study.
详细描述
The goal of this clinical trial is to compare the nutritional parameters after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL.
The main questions it aims to answer are:
- Would thigh muscle thickness change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL?
- Would triceps skin fold thickness, mid-arm circumferences, mid-arm muscle circumferences, skeletal muscle mass, appendicular skeletal muscle mass, skeletal muscle index and fat mass change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL?
- Would handgrip strength change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL?
- Would serum albumin change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL?
- Would score for cirrhotic severity such as Model for End-Stage Liver Disease-Sodium Score (MELD-Na score) and Child Turcotte Pugh Score change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL?
Participants will be asked to do following tasks:
- Participants will be asked for basic information such as age, place of residence, and contact telephone number.
- Participants will undergo measurements of weight, height, body mass index, skinfold thickness on the arms, circumference of the arms and legs, muscle mass, and body fat content using a body composition analyzer, both at the beginning and end of the research study.
- Participants will perform grip strength measurements, at both the beginning and end of the research study.
- Participants will undergo laboratory tests, including a complete blood count, liver and kidney function tests, blood clotting factors, and blood mineral levels, with a total blood volume of approximately 15 milliliters (1 tablespoon), collected twice during the study (at the beginning and end).
- Participants will be administered supplements containing branched-chain amino acids (BCAA) twice a day for a total of 12 weeks.
- Participants will be appointed for follow-up during the study, totaling 2 appointments at weeks 4 and 12. Side effects related to medication will be asked.
- Participants will undergo ultrasound measurements of the right thigh to assess thigh muscle thickness, both at the beginning and end of the research study.
- Participants will will complete questionnaires to assess your overall quality of life twice, both at the beginning and end of the research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic patients of all etiology with aged of 18-85 years
- •Clinically detectable ascites
- •Serum albumin < 3 g/dL
排除标准
- •Patients with hepatocellular carcinoma outside the Milan criteria.
- •Patients with history of gastrointestinal bleeding and spontaneous bacterial peritonitis (SBP) within the last 3 months.
- •Patients with acute on chronic liver failure (ACLF).
- •Patients with uncontrollable chronic comorbidities, including chronic heart failure in NYHA stages 3-4, end stage kidney disease requiring dialysis, and chronic obstructive pulmonary disease Gold D.
- •5 .Patients who have undergone liver or kidney transplant.
- •Patients with Human Immunodeficiency Virus (HIV).
- •Pregnant or lactating patients.
- •Patients who have undergone large volume paracentesis (>5 liters) with intravenous albumin administration on the day of study enrollment.
- •Patients with a history of above-knee amputation surgery.
- •Patients with a history of receiving intravenous albumin administration every 1-2 weeks within the last one month.
研究组 & 干预措施
branched-chain amino acid
Oral branched-chain amino acid (BCAA) is provided to the patients with a recommended daily intake of approximately 13.68 grams per day. Each sachet contains 6.84 grams of BCAA (valine 1.82 grams, leucine 3.29 grams, isoleucine 1.72 grams), total protein 17.08 grams, carbohydrates 25.48 grams, fat 5.66 grams, providing 221.2 kcal of energy. Each sachet weighs 52 grams and should be mixed with 150 ml of water. The recommended daily intake is 2 sachets, to be consumed after breakfast and dinner. The BCAA provided to the patients comes in pre-packaged silver sachets, with the manufacturing date and expiration date indicated.
干预措施: Branched-chain amino acid (Drug)
结局指标
主要结局
Average Compression Index
时间窗: 12 weeks
The Average Compression Index (cm/m2) will be calculated by taking average of thigh muscle thickness (centimeter) measured by compression weight reading divided by height (m\^2). Increase in average compression index implies better nutritional status.
thigh muscle thickness by ultrasound
时间窗: 12 weeks
Thigh muscle thickness (centimeters) by ultrasound of right thigh will be performed according to these instructions 1. Measure the thickness of the right thigh muscles, which are the rectus femoris and vastus intermedius, at a position one-third between the upper edge of the patella bone to the iliac crest, with the patient lying flat. In that position, measure the thigh muscle thickness using two methods: a. Compression reading: Measure the muscle thickness by pressing the probe head until it cannot be compressed further. b. Feather weight reading: Measure the muscle thickness without applying pressure to the probe head. Take the muscle thickness measurements twice for each method, calculate their averages. Increase in thigh muscle thickness implies better nutritional status.
Average Feather Index
时间窗: 12 weeks
The Average Feather Index (cm/m2) will be calculated by taking average of thigh muscle thickness (centimeter) measured by feather weight reading divided by height (m\^2). Increase in average feather index implies better nutritional status.
次要结局
- triceps skin fold thickness(12 weeks)
- mid-arm circumferences(12 weeks)
- skeletal muscle mass(12 weeks)
- appendicular skeletal muscle mass(12 weeks)
- skeletal muscle index(12 weeks)
- Fat mass(12 weeks)
- Handgrip strength(12 weeks)
- MELD Na Score(12 weeks)
- mid-arm muscle circumferences(12 weeks)
- Child Turcotte Pugh Score(12 weeks)
- Serum albumin(12 weeks)
研究者
Phunchai Charatcharoenwitthaya
Professor
Mahidol University