Controlled comparative study for nutritional improvement among branched chain amino acids(BCAA),general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices.

UMIN ID: UMIN000001534

Registered date:30/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: esophageal varices
• Date of first enrollment: 2008/11/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patients without BCAA before this study. This group reseives no additional nutrient during whole period of this study.(GroupA)
Patients without BCAA before this study. This group reseives two packs of a general liquid nutrient(Racol) per day in two divided breakfast and bedtime during first 14days.Thereafter,no additional nutrient is administered till the end of this study.(GroupB)
Patients without BCAA before this study. This group reseives two packs of a BCAA-rich nutrient(AminolebanEN) per day in two divided breakfast and bedtime during first 14days,and one pack per day in one divided bedtime next 42days.(GroupC)
Patients with BCAA before this study. This group reseives three packs of a BCAA(Livact) per day in two divided breakfast and bedtime during first 14days,and three pack per day in three divided breakfast lunch dinner next 42days.(GroupD)
Patients with BCAA before this study. This group reseives two packs of a BCAA-rich nutrient(AminolebanEN) per day in two divided breakfast and bedtime during first 14days,and next 42days.(GroupE)

Outcome(s)

• Primary Outcome: 1.The rate of improvement in nutritional metabolism using indirect calorimetry The starting date of study is defined as day0, and endscopic therapies are conducted on day0,day7 and day14. The rate of improvement in non-protein respiratory quotient(npRQ) using indirect calorimetry are evaluated every therapic day.
• Secondary Outcome: 1.The rate of improvement by Subjective Global Assessment The rate of improvements in subjective symptom and physical measurement are evaluated on day0,day7,day14,and day56. 2.The transition of serum protein The transitional changes of serum albumin, pre-albumin, retinol-binding protein(RBP), branched chain amino acid & tyrosine ratio(BTR) are evaluated on day0,day7,day14,and day56. 3.The changes of glucose tolerance Glucose tolerance in fasting blood sugar,immunoreactive insulin(IRI) are evaluated on day0,day7,day14,and day56

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.patients who took regular administration of albumin products more than once a week for one month. 2.patients with severe disorder of glucose metabolism. 3.patients with severe renal failure. 4.patients with congenital disorder of amino-acid metabolism. 5.patients who are regarded in-eligible by the doctor who participates in this study.

Related Information

• Primary Sponsor: Hyogo College Medicine Department of internal medicine Division of Hepatobiliary and Pancreatc Disease
• Source(s) of Monetary Support: Hyougo College of Medicine