Determining the effects of caffeine supplementation on clinical indicators and disease severity in cirrhotic patients
Design
A randomized, double-blinded, controlled clinical trial with a parallel-group design of 42 patients. Random number table will be used for randomization.
Settings and conduct
50 eligible patients with cirrhosis will randomly take two capsules daily, each containing 200 mg of caffeine or placebo for 8 weeks. All patients will also receive standard medical treatment. 12 cc blood samples will be taken from all patients before and after the intervention, to determine CBC, kidney and liver function, and inflammatory markers and patients' clinical signs will be recorded during the study. None of the participants will be aware of the type of capsule received. In this study participants and investigators will be blinded and concealment will be done by a third person
Participants/Inclusion and exclusion criteria
Individuals who are willing to cooperate in the research and with a clinical diagnosis of liver cirrhosis who refer to Taleghani Hospital, if they are in the age range of 18 to 75 years and have the ability to receive the capsules orally, will be included in the study. Also, people who are pregnant or breastfeeding, have a history of caffeine allergy, consume more than 3 cups of coffee a day, and those with extrahepatic insufficiency will not be included in the study.
Intervention groups
1- Caffeine group: receiving 400mg of caffeine daily in the form of 200mg tablet for 8 weeks 2-Placebo group: placebo tablets containing starch for 8 weeks
Main outcome variables
Blood platelet levels, Model for end-stage liver cirrhosis (MELD) score, child-pugh score and fibrosis 4 score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100524004010N34
Registration date:2022-07-08, 1401/04/17
Registration timing:registered_while_recruiting
Last update:2022-07-08, 1401/04/17
Update count:0
Registration date
2022-07-08, 1401/04/17
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-03, 1401/04/12
Expected recruitment end date
2022-10-04, 1401/07/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of caffeine supplementation on clinical parameters and disease severity in patients with hepatic cirrhosis
Public title
The effects of caffeine supplementation on clinical parameters and disease severity in patients with hepatic cirrhosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having desire to participate in the study
Age range of 18-75
BMI between 18.5 to 30 kg per square meter
Do not develop extrahepatic organ failure
Do not take caffeinated drugs for one month before the start of the study
Do not consume more than 3 cups of coffee per day
Not pregnant or breastfeeding
Exclusion criteria:
The patient's unwillingness to continue cooperation
Patients who have consumed less than 80% of the capsules.
The diagnosis of the treating physician at the end of the patient's participation in the study
Pregnancy or breastfeeding
Loss of more than 10% of body weight during the study period
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants were classified into two groups with normal (18.5-24.9) and overweight (24.9-29.9) by stratified blocked randomization method and based on BMI and randomly assigned to One of the groups caffeine consumption or placebo consumption group. Separate randomization is done based on BMI within each group. The size of the blocks is 4, with two assignments to the intervention group (A) and two allocations to the control group (B). There are 6 different permutations of AABB, ABAB, BBAA, BABA, ABBA, BAAB.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients won’t know if they are receiving the caffeine or a placebo for double-blinding the study, the bottles containing the relevant soft gels will be concealed as A and B by a third person at the beginning of the study, and none of the research team members will know the type of soft gels received by each group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the National Institute of Nutritional Research and Food Industry
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehrab
Province
Tehran
Postal code
1981619573
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1401.009
Health conditions studied
1
Description of health condition studied
Hepatic Cirrhosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Model for end-stage liver cirrhosis score (MELD score)
Timepoint
At the beginning and the end of the study
Method of measurement
Using the formula
Secondary outcomes
1
Description
Serum total billirubin
Timepoint
At the beginning and the end of the study
Method of measurement
Enzymatic method
2
Description
Serum albumin
Timepoint
At the beginning and the end of the study
Method of measurement
Enzymatic method
3
Description
Serum Alanine transaminase (ALT)
Timepoint
At the beginning and the end of the study
Method of measurement
Enzymatic method
4
Description
Serum Aspartate aminotransferase (AST)
Timepoint
At the beginning and the end of the study
Method of measurement
Enzymatic method
5
Description
Serum creatinine
Timepoint
At the beginning and the end of the study
Method of measurement
Enzymatic method
6
Description
Serum Na
Timepoint
At the beginning and the end of the study
Method of measurement
Enzymatic method
7
Description
Serum Alkaline phosphate (ALP)
Timepoint
At the beginning and the end of the study
Method of measurement
Enzymatic method
8
Description
International normalized ratio (INR)
Timepoint
At the beginning and the end of the study
Method of measurement
Calculate the ratio
9
Description
Prothrombin time (PT)
Timepoint
At the beginning and the end of the study
Method of measurement
Prothrombin time measurement
10
Description
Partial thromboplastin time (PTT)
Timepoint
At the beginning and the end of the study
Method of measurement
Partial Thromboplastin Time measurement
11
Description
Serum platelets
Timepoint
At the beginning and the end of the study
Method of measurement
Automatic cell count
12
Description
Tumor necrosis factor-alpha (TNF-a)
Timepoint
At the beginning and the end of the study
Method of measurement
ELISA method
13
Description
Interleukin 6 (IL-6)
Timepoint
At the beginning and the end of the study
Method of measurement
ELISA method
14
Description
Serum c-reactive protein (CRP)
Timepoint
At the beginning and the end of the study
Method of measurement
ELISA method
15
Description
Child pugh score
Timepoint
At the beginning and the end of the study
Method of measurement
Using the formula
16
Description
Fibrosis 4 score
Timepoint
At the beginning and the end of the study
Method of measurement
Using the formula
17
Description
AST to platelets ratio index (APRI)
Timepoint
At the beginning and the end of the study
Method of measurement
Calculate the ratio
Intervention groups
1
Description
Intervention group: Will take 400 mg of caffeine daily in the form of two tablets each contains 200 mg of caffeine (Product of raha Company) orally for eight weeks.
Category
Other
2
Description
Control group: Will take two placebo tablets daily, which are similar in shape and taste to caffeine tablets, orally for eight weeks.