MalnutritionNCT03354299
Effect of Coconut Milk Supplementation to Improve Nutritional Status in Cirrhosis Patient
A study testing coconut milk in people with Malnutrition and Cirrhosis, Liver, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Cirrhosis, Liver
- What is being tested?
- coconut milk
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIndonesia
- Study dates
- Jun 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Using pace maker
- Diabetes mellitus patients
- End-stage renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beneficial Effects of Coconut Milk Supplementation to Improve Nutritional Status in Patients With Liver Cirrhosis
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.
Read more
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.
Read the 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
- Being tested
- coconut milk
- Keywords
- malnutrition, liver cirrhosis, coconut milk
- Medical subject headings
- Malnutrition, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coconut milkDietary supplement
50 cc of coconut milk supplementation plus 25 gram sugar (pudding) was given to cirrhosis patients as late night snack
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Group I patients received 25 gram of sugar (pudding) and 50 cc of coconut milk as late night snack for a month Receives: Dietary Supplement: coconut milk |
| Group II | Active comparator | Group II patients received 50 gram of sugar (25 gram pudding and 25 gram syrup) as late night snack for a month Receives: Dietary Supplement: coconut milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change of BMI at 1 month after supplementation
Triceps Skinfold Thickness (TSF)
Triceps skinfold thickness is calculated by skinfold calliper. Unit of measure: millimeter (mm)
Measured: Change of TSF at 1 month after supplementation
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)
Measured: Change of MAMC at 1 month after supplementation
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
Measured: Change of BFM at 1 month after supplementation
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)
Measured: Change of prealbumin and albumin serum at 1 month after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study startJun 2014
- Primary completionJul 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rino Alvani Gani, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Rino A Gani, PhD, Principal investigator, Dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354299
- Sponsor's protocol ID
- 75/UN2.F1/ETIK/2015
- Status last verified
- Nov 2017
- First submitted
- 13 Nov 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Coconut Milk Supplementation to Improve Nutritional Status in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT03354299
- Acronym / sponsor ID
- 75/UN2.F1/ETIK/2015
- Conditions
- Malnutrition, Cirrhosis, Liver
- Keywords
- malnutrition, liver cirrhosis, coconut milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Dietary Supplement: coconut milkGroup I patients received 25 gram of sugar (pudding) and 50 cc of coconut milk as late night snack for a month |
| Group II | Active comparator | Dietary Supplement: coconut milkGroup II patients received 50 gram of sugar (25 gram pudding and 25 gram syrup) as late night snack for a month |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cirrhosis patients, Child Pugh A and B who are not critically ill, and develop one of following condition :
Key exclusion criteria (3 listed)
- Using pace maker
- Diabetes mellitus patients
- End-stage renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coconut milk50 cc of coconut milk supplementation plus 25 gram sugar (pudding) was given to cirrhosis patients as late night snack | Dietary supplement | Group I, Group II |
Primary outcome
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
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)
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)
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rino A Gani, PhD principal investigator
Dr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coconut milk in people with Malnutrition and Cirrhosis, Liver, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: Change of BMI at 1 month after supplementation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.