The effects of flaxseed powder consumption on disease severity, biochemical, inflammatory, anthropometric, sarcopenic parameters and quality of life in patients with liver cirrhosis.
Determining the effects of flaxseed powder consumption on disease severity, biochemical, inflammatory, anthropometric, sarcopenic parameters and quality of life in patients with liver cirrhosis.
Design
A controlled, parallel-group, open-label, randomized clinical trial of 50 patients. Sealedenvelope software is used for randomization.
Settings and conduct
This international study will be conducted on cirrhotic patients with the aim of the effects of flaxseed powder on these patients at the Institute of Gastrointestinal and Liver Diseases of Shahid Beheshti University of Medical Sciences in Tehran. 25 patients in each group are divided into intervention and control groups to participate in this research. After the baseline general information registration , two stages of blood sampling are done at the beginning and 12 weeks after the start of the study in order to check the outcomes of the research, including the severity of the disease, biochemical and inflammatory parameters. Also, anthropometric and sarcopenic indicators will be measured, as well as changes in the quality of life in the above two time periods will be assessed in these people.
Participants/Inclusion and exclusion criteria
Participants: patients with liver cirrhosis
Inclusion criteria:
People with liver cirrhosis who may benefit from flexseed powder
non inclusion criteria:
Any condition that can endanger the patient's current condition
Intervention groups
The patients of the intervention group will receive 30 grams of flaxseed powder daily for 12 weeks. The patients are asked to consume a 30 gram packet every night with water, cold liquids or salad.
Main outcome variables
Severity of liver cirrhosis based on Model for end stage liver disease (MELD)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230514058189N1
Registration date:2023-05-19, 1402/02/29
Registration timing:prospective
Last update:2023-05-19, 1402/02/29
Update count:0
Registration date
2023-05-19, 1402/02/29
Registrant information
Name
fereshteh pashayee-khamene
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8319
Email address
fereshteh.pashai@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of flaxseed powder consumption on disease severity, biochemical, inflammatory, anthropometric, sarcopenic parameters and quality of life in patients with liver cirrhosis.
Public title
Effects of flaxseed consumption in liver cirrhosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with liver cirrhosis whose cirrhosis has been confirmed by a specialist physician.
Exclusion criteria:
Those who have other extrahepatic diseases at the same time.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method is used individually using sealedenvelope software. In order to hide the order of the codes, they are placed in closed envelopes so that the researcher does not know the order of the codes for the entry of people into the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz jundi shapour University of Medical Sciences
Street address
jundishapour university of medical sciences, golestan, ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.AJUMS.REC.1402.090
Health conditions studied
1
Description of health condition studied
liver cirrhosis
ICD-10 code
K74
ICD-10 code description
Fibrosis and cirrhosis of liver
Primary outcomes
1
Description
Severity of liver cirrhosis according to Model for end stage liver disease score (MELD)
Timepoint
Measurement of disease severity based on the MELD score before and 12 weeks after the start of flaxseed powder consumption
Method of measurement
Calculation of MELD using the formula and variables of bilirubin, creatinine and INR
Secondary outcomes
1
Description
Cirrhosis severity score based on child-Pugh
Timepoint
Measurement of mean cirrhosis severity based on child-Pugh score before and 12 weeks after flaxseed powder consumption
Method of measurement
child-Pugh calculation formula using the variables of bilirubin, albumin, INR (international normalized ratio), presence or absence of ascites and encephalopathy
2
Description
Level of serum total cholesterol
Timepoint
Measurement of mean level of serum total cholesterol before and 12 weeks after flaxseed powder consumption
Method of measurement
Auto Analyzer and Total Cholesterol Test Kit (Biorex)
3
Description
Level of serum low density lipoprotein (LDL)
Timepoint
Measurement of mean level of serum LDL before and 12 weeks after flaxseed powder consumption
Method of measurement
Auto Analyzer and LDL Test Kit (Biorex)
4
Description
Level of serum high density lipoprotein (HDL)
Timepoint
Measurement of mean level of HDL before and 12 weeks after flaxseed powder consumption
Method of measurement
Auto Analyzer and HDL Test Kit (Biorex)
5
Description
Level of serum triglyceride (TG)
Timepoint
Measurement of mean level of serum TG before and 12 weeks after flaxseed powder consumption
Method of measurement
Auto Analyzer and TG Test Kit (Biorex)
6
Description
Level of serum fasting blood sugar (FBS)
Timepoint
Measurement of mean level of FBS before and 12 weeks after flaxseed powder consumption
Method of measurement
Auto Analyzer and FBS Test Kit (Biorex)
7
Description
Level of serum insulin
Timepoint
Measurement of mean level of serum insulin before and 12 weeks after flaxseed powder consumption
Method of measurement
Enzyme-linked immunosorbent double- antibody sandwich assay and insulin Test Kit (monobind)
8
Description
Homeostatic Model Assessment (HOMA-IR ) index
Timepoint
Measurement of HOMA-IR before and 12 weeks after flaxseed powder consumption
Method of measurement
HOMA-IR calculation formula
9
Description
Quantitative insulin sensitivity check index (QUICKI)
Timepoint
Measurement of QUICKI before and 12 weeks after flaxseed powder consumption
Method of measurement
QUICKI calculation formula
10
Description
Level of serum total bilirubin
Timepoint
Measurement of mean level of serum total bilirubin before and 12 weeks after flaxseed powder consumption
Method of measurement
Auto Analyzer and total bilirubin Test Kit (Biorex)
11
Description
Level of serum albumin
Timepoint
Measurement of mean level of serum albumin before and 12 weeks after flaxseed powder consumption
Method of measurement
Auto Analyzer and albumin Test Kit (Biorex)
12
Description
Level of serum gamma-glutamyl transferase (GGT)
Timepoint
Measurement of mean level of serum GGT before and 12 weeks after flaxseed powder consumption
Method of measurement
Auto Analyzer and GGT Test Kit (Biorex)
13
Description
Level of serum creatinine
Timepoint
Measurement of mean level of serum creatinine before and 12 weeks after flaxseed powder consumption
Method of measurement
Auto Analyzer and creatinine Test Kit (Biorex)
14
Description
Level of serum sodium
Timepoint
Measurement of mean level of serum sodium before and 12 weeks after flaxseed powder consumption
Method of measurement
standard solution Na
15
Description
Prothrombin time (PT)
Timepoint
Measurement of PT before and 12 weeks after flaxseed powder consumption
Method of measurement
manual
16
Description
Partial prothrombin time (PTT)
Timepoint
Measurement of PTT before and 12 weeks after flaxseed powder consumption
Method of measurement
manual
17
Description
International normalized ratio (INR)
Timepoint
Measurement of INR before and 12 weeks after flaxseed powder consumption
Method of measurement
Manual
18
Description
level of serum High-sensitivity C-reactive Protein (hs-CRP)
Timepoint
Measurement of serum hs-CRP before and 12 weeks after flaxseed powder consumption
Method of measurement
Enzyme-linked immunosorbent double- antibody sandwich assay and hs-CRP Test Kit (Zelbio)
19
Description
Level of serum apelin
Timepoint
Measurement of serum apelin before and 12 weeks after flaxseed powder consumption
Method of measurement
Enzyme-linked immunosorbent double- antibody sandwich assay and apelin Test Kit (Zelbio)
20
Description
body weight
Timepoint
Measurement of body weight mean before and 12 weeks after flaxseed powder consumption
Method of measurement
weight scale
21
Description
body mass index (BMI)
Timepoint
Measurement of BMI mean before and 12 weeks after flaxseed powder consumption
Method of measurement
Calculation by formula
22
Description
lean body mass (LBM)
Timepoint
Measurement of LBM mean before and 12 weeks after flaxseed powder consumption
Method of measurement
using of body analyzer (in body 270)
23
Description
fat mass (FM)
Timepoint
Measurement of FM mean before and 12 weeks after flaxseed powder consumption
Method of measurement
using of body analyzer (in body 270)
24
Description
fat mass percent (FM%)
Timepoint
Measurement of FM% mean before and 12 weeks after flaxseed powder consumption
Method of measurement
using of body analyzer (in body 270)
25
Description
muscle strength
Timepoint
Measurement of muscle strength mean before and 12 weeks after flaxseed powder consumption
Method of measurement
using hand grip dynamometer (jamar hydraulic hand dynamometer B001D7QDJG)
26
Description
muscle arm circumference (MAC)
Timepoint
Measurement of MAC mean before and 12 weeks after flaxseed powder consumption
Method of measurement
using tape
27
Description
triceps skinfold thickness (TSF)
Timepoint
Measurement of TSF mean before and 12 weeks after flaxseed powder consumption
Method of measurement
using caliper (Harpenden skinfold caliper FG1056)
28
Description
frailty
Timepoint
Measurement of frailty mean before and 12 weeks after flaxseed powder consumption
Method of measurement
using liver frailty index (LFI) questionnaire
29
Description
sarcopenia
Timepoint
Measurement of sarcopenia mean before and 12 weeks after flaxseed powder consumption
Method of measurement
using Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire (SARC-F)
30
Description
quality of life score
Timepoint
Measurement of mean quality of life score before and 12 weeks after flaxseed powder consumption
Method of measurement
using 36-Item Short Form Survey (SF-36) questionnaire
31
Description
Mid arm muscle arm circumference (MAMC)
Timepoint
Measurement of MAMC mean before and 12 weeks after flaxseed powder consumption
Method of measurement
Calculation by formula using muscle arm circumference (MAC) and triceps skinfold thickness (TSF)
Intervention groups
1
Description
Intervention group: Patients in the intervention group will receive 30 grams of flaxseed powder daily for 12 weeks. Fresh flaxseed will be prepared and ground from Zarin giyahine store. 30 gram packages of flaxseed powder with the relevant packaging and label have been prepared and the consumption amount for one month will be provided to the patients. Patients are asked to consume one 30 gram packet every night with water, cold liquids or salad.
Category
Treatment - Other
2
Description
Control group: patients in the control group do not receive any food or placebo and the study is open labeled.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Institute of Gastrointestinal and Liver Diseases, Shahid Beheshti University of Medical Sci