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

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ClinicalTrials.gov Identifier: NCT03354299
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Rino Alvani Gani, Dr Cipto Mangunkusumo General Hospital

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.


Condition or disease Intervention/treatment Phase
Malnutrition Cirrhosis, Liver Dietary Supplement: coconut milk Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Beneficial Effects of Coconut Milk Supplementation to Improve Nutritional Status in Patients With Liver Cirrhosis
Actual Study Start Date : June 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I
Group I patients received 25 gram of sugar (pudding) and 50 cc of coconut milk as late night snack for a month
Dietary Supplement: coconut milk
50 cc of coconut milk supplementation plus 25 gram sugar (pudding) was given to cirrhosis patients as late night snack

Active Comparator: Group II
Group II patients received 50 gram of sugar (25 gram pudding and 25 gram syrup) as late night snack for a month
Dietary Supplement: coconut milk
50 cc of coconut milk supplementation plus 25 gram sugar (pudding) was given to cirrhosis patients as late night snack




Primary Outcome Measures :
  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)



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354299


Locations
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Indonesia
Hepatobiliary Division
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Dr Cipto Mangunkusumo General Hospital
Investigators
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Principal Investigator: Rino A Gani, PhD Dr

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Responsible Party: Rino Alvani Gani, Head of Hepatobiliary, Dr Cipto Mangunkusumo General Hospital
ClinicalTrials.gov Identifier: NCT03354299     History of Changes
Other Study ID Numbers: 75/UN2.F1/ETIK/2015
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Rino Alvani Gani, Dr Cipto Mangunkusumo General Hospital:
malnutrition
liver cirrhosis
coconut milk

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Malnutrition
Pathologic Processes
Liver Diseases
Digestive System Diseases
Nutrition Disorders