Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation

Universidad de Guanajuato

Status: Unknown

Conditions: Liver Cirrhosis

Treatments: Dietary Supplement: Late evening supplementation with branched chain amino acids

Study type: Interventional

Funder types: Other

Identifiers

NCT02407769

GAS-1103-13/14-1

Details and patient eligibility

About

Assess the impact in body composition and handgrip strength of the nocturne supplementation by a month with BCAA (Enterex hepatic in patients awaiting liver transplantation)

Full description

Clinical trial study was make, data were obtained from people awaiting liver transplantation and with at least a criteria of protein/energy malnutrition (fase angle < 5.4°, subjective global assessment B or C and/or handgrip strength < 30 in men and < 20 in women). The investigators make them body composition assessment (weight, height, body mass index [BMI], mean arm circumference [MAC], muscle arm area [MAA], tricipital skinfold, Dual X ray absorptiometry [fat mass and fat free mass]) and handgrip strength at beginning and after 30 days of nocturne supplementation with BCAA and standardized diet (35-40 Kcal, 55% carbohydrates, 25% lipids and 20% proteins).

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients on waiting list for liver transplantation.
• Diagnosis of undernutrition.

Exclusion criteria

• Hepatorrenal syndrome.
• Hepatopulmonar syndrome
• Diabetes
• Overweight

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Branched chain amino acids

Experimental group

Description:

The patients will drink a Enterex Hepatic bag (500 Kcal, 18.6g of proteins of which 8.63g are branched chain amino acids, 71.7g of carbohydrates and 15.4g of lipids) during the late evening (after 19:00 hours) daily by two months.

Treatment:

Dietary Supplement: Late evening supplementation with branched chain amino acids

Late evening snack

Sham Comparator group

Description:

The patients will eat a snack with similar nutrimental facts that food supplement (480 Kcal, 19g of proteins and they were based in casein and vegetable proteins; 17g of lipids and 63g of carbohydrates) during the late evening (after 19:00 hours) daily by two months.

Treatment:

Dietary Supplement: Late evening supplementation with branched chain amino acids