Effect of Coconut Milk Supplementation to Improve Nutritional Status in Cirrhosis Patient

NCT ID: NCT03354299

Last Updated: 2017-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-03-31

Brief Summary

Liver cirrhosis still becomes a major issue in Indonesia. Malnutrition has been observed in liver cirrhosis patients as it deteriorates liver function and cirrhosis itself. Malnutrition in liver cirrhosis can increase morbidity and mortality rates.

Patients with liver cirrhosis have increased energy expenditure and endogenous fat oxidation reaction which is used as the basic energy sources. Energy obtained from fat was accounted for 86% of the total energy sources in this population. Fatty acid is also known to be an efficient energy backup for hepatocytes and other cells because it generates higher adenosine triphosphate (ATP) than other sources.

Supplementary diet for patients with liver cirrhosis is considered beneficial for preventing hypercatabolism. To fulfill their nutritional needs, patients with liver cirrhosis is advised to take an extra food, such as a late night snack (LNS) with a total carbohydrate of around 50 g (equivalent to 200 kkal). Considering that most of the energy source in patients with liver cirrhosis came from fat, so the additional sources of energy having a high fat content were considered to be potentially highly beneficial to address the patients' nutritional status, as well as to reduce the risk of hyperglycemia after a meal and hypoglycemia after a long night fasting period time.

Coconut milk contains many saturated fatty acids belonging to the medium chain triacylglycerol (MCT) group. The characteristics of MCT are quite different from long chain triacylglycerol (LCT). MCTs are more easily absorbed than LCTs, and are mostly absorbed in the form of free fatty acids, in both healthy and liver cirrhosis populations.

This study wants to investigate the effects of coconut milk supplementation on improving the nutritional status of patients with liver cirrhosis. The patients were divided into 2 groups, groups I received 25 g of sugar plus 50 cc of coconut milk (200 kkal) as late night snacks (LNS); and group II received 50 g of sugar alone (200 kkal) as LNS. Investigators think that the group who received coconut milk supplementation has better nutritional status than the other group.

Detailed Description

This study investigated the effects of coconut milk supplementation on improving the nutritional status of patients with liver cirrhosis. Design was randomized controlled trial. Investigators randomized the patients into 2 groups. Group I received 25 gram of sugar + 50 cc coconut milk and group II received 50 gram of sugar alone. Both of groups received 200 kkal as late night snack. Subjects were cirrhosis patients with Child Pugh A and B, who develop malnutrition using BMI criteria or experience unintentional weight loss. The outcome was nutritional parameters after 1 month supplementation.

Estimated sample was 60 patients with 30 subjects in group I and 30 subjects in group II.

Conditions

Malnutrition; Cirrhosis, Liver

Keywords

malnutrition; liver cirrhosis; coconut milk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group I

Group I patients received 25 gram of sugar (pudding) and 50 cc of coconut milk as late night snack for a month

Group Type: EXPERIMENTAL

coconut milk

Intervention Type: DIETARY_SUPPLEMENT

50 cc of coconut milk supplementation plus 25 gram sugar (pudding) was given to cirrhosis patients as late night snack

Group II

Group II patients received 50 gram of sugar (25 gram pudding and 25 gram syrup) as late night snack for a month

Group Type: ACTIVE_COMPARATOR

coconut milk

Intervention Type: DIETARY_SUPPLEMENT

50 cc of coconut milk supplementation plus 25 gram sugar (pudding) was given to cirrhosis patients as late night snack

Interventions

coconut milk

50 cc of coconut milk supplementation plus 25 gram sugar (pudding) was given to cirrhosis patients as late night snack

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Cirrhosis patients, Child Pugh A and B who are not critically ill, and develop one of following condition :

1. Malnutrition with modified BMI criteria such as BMI < 22 kg/m2 for non ascites, BMI < 23 for mild ascites, and BMI < 25 for severe ascites

2. Unintentional weight loss, defined as decline 5% weight loss for period 6-12 month or less

Exclusion Criteria

• Using pace maker
• Diabetes mellitus patients
• End-stage renal disease

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rino Alvani Gani

Head of Hepatobiliary

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rino A Gani, PhD

Role: PRINCIPAL_INVESTIGATOR

Dr

Locations

Hepatobiliary Division

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

75/UN2.F1/ETIK/2015

Identifier Type: -

Identifier Source: org_study_id