Effect of supplementation with the amino acid leucine and the compound Beta-hydroxy-beta-methyl-butyrate on the nutritional status, muscle mass, functionality and blood tests of patients on the waiting list for liver transplantation

Effect of Leucine and Beta-hydroxy-beta-methyl-butyrate supplementation on nutritional status, lean mass, functionality, biochemical and molecular markers of patients on the waiting list for liver transplantation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-9snttn

Enrollment

Unknown

Registered

2020-04-27

Start date

2020-07-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver cirrhosis

Interventions

Experimental group: 22 patients on the waiting list for liver transplantation receiving chocolates enriched with (7.5 g of leucine). Control group: 22 patients on the liver transplant waiting list to

protein content: 1.5g / kg

the percentage of carbohydrates: 50 to 70%

the percentage of lipids: 20 to 30%

fibers: 25g

vitamins and minerals according to Reference Dietary Consumption

small meals evenly distributed throughout the day and one last meal after 21 hours, containing 50g of carbohydrate or supplement.

Dietary supplement

D12.125.070.637

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients on the waiting list for liver transplantation; both genders; age over 18 years

Exclusion criteria

Exclusion criteria: Pregnant and lactating women; vegetarians; allergic to milk and soy proteins; lactose intolerant; patients taking nutritional supplements of free amino acids; patients using progestational agents, steroids and growth hormone

Design outcomes

Primary

Measure	Time frame
"Expected outcome 1" Improvement of nutritional status and lean mass is expected, which will be assessed through the subjective global assessment, weight, height, triceps skinfold, arm circumference, calf circumference, adductor pollicis muscle thickness, muscle circumference of the arm, arm muscle area, bioimpedance and computed tomography of the cross-sectional area of the skeletal muscle at the level of the third lumbar vertebra. Evaluate sarcopenia, through the assessment of handgrip strength and the short physical performance battery test.;"Expected outcome 2" It is expected to improve the functionality that will be assessed by the short physical performance battery test and the quality of life that will be assessed using a semi-structured questionnaire for liver patients.;"Expected outcome 3" It is hoped that the biochemical and molecular markers of sarcopenia will improve, such analyzes will be carried out in a sub-sample, for which blood will be collected from the patients at the beginning and at the end of the intervention. The tests will be carried out using immunoenzymatic assay techniques.	—

Measure

Time frame

"Expected outcome 1" Improvement of nutritional status and lean mass is expected, which will be assessed through the subjective global assessment, weight, height, triceps skinfold, arm circumference, calf circumference, adductor pollicis muscle thickness, muscle circumference of the arm, arm muscle area, bioimpedance and computed tomography of the cross-sectional area of the skeletal muscle at the level of the third lumbar vertebra. Evaluate sarcopenia, through the assessment of handgrip strength and the short physical performance battery test.;"Expected outcome 2" It is expected to improve the functionality that will be assessed by the short physical performance battery test and the quality of life that will be assessed using a semi-structured questionnaire for liver patients.;"Expected outcome 3" It is hoped that the biochemical and molecular markers of sarcopenia will improve, such analyzes will be carried out in a sub-sample, for which blood will be collected from the patients at the beginning and at the end of the intervention. The tests will be carried out using immunoenzymatic assay techniques.

—

Secondary

Measure	Time frame
"Expected outcome 4" To evaluate the acute effect of leucine supplementation on biochemical, molecular and histochemical markers in patients who interrupt the supplementation to perform the transplant before the end of the study, thus a biopsy of the skeletal muscle will be collected in a sub-sample, and the markers will be collected will be evaluated by immunobloting and pcr in real time.	—

Countries

Brazil

Contacts

Public ContactLucilene Anastácio

Universidade Federal de Minas Gerais

lucilenerezende@ufmg.br+55 031 34096917

Outcome results

None listed

Source: REBEC (via WHO ICTRP)