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NCT Number: NCT03354299

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

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.

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Key information

Conditions

Malnutrition Cirrhosis, Liver Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hepatobiliary Division

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

coconut milk

Dietary Supplement

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

Primary outcomes

  1. Body Mass Index (BMI)

    Time frame: Change of BMI at 1 month after supplementation

    Body mass index is calculated by divided weight (in kg) with square of height (in meter). Unit of measure: kg/m2

  2. Triceps Skinfold Thickness (TSF)

    Time frame: Change of TSF at 1 month after supplementation

    Triceps skinfold thickness is calculated by skinfold calliper. Unit of measure: millimeter (mm)

  3. MAMC (Mid arm muscle circumference)

    Time frame: Change of MAMC at 1 month after supplementation

    Mid arm muscle circumference is calculate by formula as follow:

    MAMC = MUAC - (TSF x 3.14). MUAC (mid upper arm circumference). Unit of measure: milimeter (mm)

  4. Body Fat Mass (BFM)

    Time frame: Change of BFM at 1 month after supplementation

    Body fat mass is calculated by calliper by pulling the fat away from the muscles, pinch them with the caliper, take the measurements, and look at a chart to figure out. Unit of measure : kg

  5. Prealbumin and albumin serum

    Time frame: Change of prealbumin and albumin serum at 1 month after supplementation

    Prealbumin serum is checked by nephelometry technique with nephelometer laser, albumin serum is checked by bromcresol green method, using ABX cobas. Both of that in milligram per deciliter (mg/dL)

Sponsors and collaborators

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Other

Registry information

Official study title

Beneficial Effects of Coconut Milk Supplementation to Improve Nutritional Status in Patients With Liver Cirrhosis

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Nov 27, 2017
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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