Effect of Coconut Milk Supplementation to Improve Nutritional Status in Cirrhosis Patient
Primary Purpose
Malnutrition, Cirrhosis, Liver
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
coconut milk
Sponsored by
About this trial
This is an interventional supportive care trial for Malnutrition focused on measuring malnutrition, liver cirrhosis, coconut milk
Eligibility Criteria
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
Sites / Locations
- Hepatobiliary Division
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I
Group II
Arm Description
Group I patients received 25 gram of sugar (pudding) and 50 cc of coconut milk as late night snack for a month
Group II patients received 50 gram of sugar (25 gram pudding and 25 gram syrup) as late night snack for a month
Outcomes
Primary Outcome Measures
Body Mass Index (BMI)
Body mass index is calculated by divided weight (in kg) with square of height (in meter). Unit of measure: kg/m2
Triceps Skinfold Thickness (TSF)
Triceps skinfold thickness is calculated by skinfold calliper. Unit of measure: millimeter (mm)
MAMC (Mid arm muscle circumference)
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)
Body Fat Mass (BFM)
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
Prealbumin and albumin serum
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03354299
First Posted
November 13, 2017
Last Updated
November 24, 2017
Sponsor
Dr Cipto Mangunkusumo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03354299
Brief Title
Effect of Coconut Milk Supplementation to Improve Nutritional Status in Cirrhosis Patient
Official Title
Beneficial Effects of Coconut Milk Supplementation to Improve Nutritional Status in Patients With Liver Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr Cipto Mangunkusumo General Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Cirrhosis, Liver
Keywords
malnutrition, liver cirrhosis, coconut milk
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
Group I patients received 25 gram of sugar (pudding) and 50 cc of coconut milk as late night snack for a month
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Group II patients received 50 gram of sugar (25 gram pudding and 25 gram syrup) as late night snack for a month
Intervention Type
Dietary Supplement
Intervention Name(s)
coconut milk
Intervention Description
50 cc of coconut milk supplementation plus 25 gram sugar (pudding) was given to cirrhosis patients as late night snack
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
Body mass index is calculated by divided weight (in kg) with square of height (in meter). Unit of measure: kg/m2
Time Frame
Change of BMI at 1 month after supplementation
Title
Triceps Skinfold Thickness (TSF)
Description
Triceps skinfold thickness is calculated by skinfold calliper. Unit of measure: millimeter (mm)
Time Frame
Change of TSF at 1 month after supplementation
Title
MAMC (Mid arm muscle circumference)
Description
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)
Time Frame
Change of MAMC at 1 month after supplementation
Title
Body Fat Mass (BFM)
Description
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
Time Frame
Change of BFM at 1 month after supplementation
Title
Prealbumin and albumin serum
Description
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)
Time Frame
Change of prealbumin and albumin serum at 1 month after supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rino A Gani, PhD
Organizational Affiliation
Dr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hepatobiliary Division
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Coconut Milk Supplementation to Improve Nutritional Status in Cirrhosis Patient
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