IRCT | The effect of chitosan supplementation on changes of body weight, glycemic risk factors (fasting glucose, insulin, glycated hemoglobin), lipid profile and visceral adiposity index in patients with nonalcoholic fatty liver disease (NAFLD)

Protocol summary

Study aim: Evaluation of the effect of chitosan supplementation on body weight changes, glycemic risk factors , lipid profiles and visceral obesity index in patients with non-alcoholic fatty liver (NAFLD)
Design: A clinical trial with (placebo) control group, with parallel groups, triple blind, randomized
Settings and conduct: This is a clinical trial study performed on Fatty liver patients referred to Golestan Hospital in 1397, who has been diagnosed at least 6 months ago. The inform consent and other information are given to the participants. Then, a 3-part questionnaire is completed by the subjects. Blood samples are collected at baseline and 12 weeks after the study (supplements and placebo).
Participants/Inclusion and exclusion criteria: Inclusion criteria: Individuals aged between 18-65 years of both genders; diagnosis of nonalcoholic fatty liver disease by ultrasound; willingness to participate; BMI between 25 to 40 Exclusion criteria: Suffering from viral hepatitis, liver cirrhosis, Wilson's disease, acute fatty liver, hepatocellular carcinoma, hypothyroidism, lipodystrophy, diseases that involves bile ducts; history of chronic liver disease; history of significant weight loss (more than 10% of body weight during 6 months ago) or weight loss surgery; history of antioxidant supplementation, omega 3 and milk thistle during 6 months ago; history of liver damaging drug; history of cardiovascular and renal disease; alcohol consumption more than 20 gram per day, pregnancy and lactation; menopause; energy consumption less than 800 or more than 4200 kilocalorie per day
Intervention groups: Intervention group: patients with nonalcoholic fatty liver, 18 to 65 years, receiving chitosan supplements for 12 weeks Control group:patients with nonalcoholic fatty liver, 18 to 65 years, receiving placebo for 12 weeks
Main outcome variables: body weight; glycated hemoglobin; fasting blood glucose; insulin

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20180412039284N1

Registration date: 2018-05-09, 1397/02/19

Registration timing: prospective

Last update: 2018-05-09, 1397/02/19

Update count: 0
Registration date: 2018-05-09, 1397/02/19

Registrant information: Name

Hedieh Rahmani

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 61 3373 8317

Email address

rahmani.he@ajums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2018-06-21, 1397/03/31
Expected recruitment end date: 2018-10-21, 1397/07/29
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of chitosan supplementation on changes of body weight, glycemic risk factors (fasting glucose, insulin, glycated hemoglobin), lipid profile and visceral adiposity index in patients with nonalcoholic fatty liver disease (NAFLD)

Public title: The effect of chitosan supplementation in patients with nonalcoholic fatty liver disease (NAFLD)
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Individuals of both genders (males and females) will be selected to participate in the study, aged between 18 and 65 years old that their fatty liver diagnosed by ultrasound testing No allergies to seafood

Exclusion criteria:

Hepatitis, liver cirrhosis, Wilson's disease, acute fatty liver, pregnancy, hepatocellular carcinoma, hypothyroidism and chronic liver disease Lipodystrophy Menopause Parenteral nutrition Diseases that involve bile ducts and bile ducts Severe weight loss (more than 10% of body weight) during last 6 months and weight loss surgery Congenital metabolic diseases Consumption of Herbal Supplements in the last three months Taking drugs that cause fatty liver and liver toxicity (amiodarone, antivirals, spirin, non-steroidal anti-inflammatory drugs, corticosteroids, methotrexate, tamoxifen, tetracycline, valproic acid Pregnancy and lactation Consumption of Omega 3 and Vitamin E and other antioxidant supplements over the past 6 months History of cardiovascular disease and kidney disease BMI between 25 and 40 Unwillingness to participate Energy consumption less than 800 or more than 4200kcal/day
Age: From 18 years old to 65 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor
Data analyser

Sample size

Target sample size: 50

Randomization (investigator's opinion)

Randomized

Randomization description

First, individuals who have the characteristics necessary to enter the study are usually taken from a non-random sample using a simple sampling method. Then, randomization is done between study groups. In this study, a block randomization method (including 4 locks) is used. One of the study partners who has not been blindfolded, named chitosan and placebo with the letters A and B (for example). Then, the researcher distributed A and B packages among patients referring to Golestan Hospital in a randomized block method (ABAB, BABA, AABB, BBAA, ABBA, BAAB; A, first person; B, Second person; A, third person; B,fourth person B etc.). Then, selecting the blocks are continued until reaching the sample size.

Blinding (investigator's opinion)

Triple blinded

Blinding description

One of the study partners who has not been blindfolded, named chitosan and placebo with the letters A and B (for example). Then, the researcher distributed A and B packages among patients referring to Golestan Hospital in a randomized block method (ABAB, BABA, AABB, BBAA, ABBA, BAAB; A, first person; B, Second person; A, third person; B,fourth person B etc.).

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ahvaz Jundishapur university of medical sciences

Street address

Ahvaz Jundishapur university of medical sciences, Ahvaz, Khuzestan, Iran

City

Ahvaz

Province

Khouzestan

Postal code

61357-15794
Approval date: 2018-03-02, 1396/12/11
Ethics committee reference number: IR.AJUMS.REC.1396.1045

Health conditions studied

1

Description of health condition studied: Nonalcoholic fatty liver
ICD-10 code: K76.0
ICD-10 code description: Nonalcoholic fatty liver disease [NAFLD]

Primary outcomes

1

Description: Glycated hemoglobin A1c
Timepoint: Before the intervention and twelve weeks after
Method of measurement: spectrophotometry

2

Description: fasting blood glucose
Timepoint: Before the intervention and twelve weeks after
Method of measurement: enzymatic method

3

Description: plasma insulin
Timepoint: Before the intervention and twelve weeks after
Method of measurement: calorimetry

4

Description: LDL
Timepoint: Before the intervention and twelve weeks after
Method of measurement: enzymatic method

5

Description: HDL
Timepoint: Before the intervention and twelve weeks after
Method of measurement: enzymatic method

6

Description: total cholesterol
Timepoint: Before the intervention and twelve weeks after
Method of measurement: enzymatic method

7

Description: triglyceride
Timepoint: Before the intervention and twelve weeks after
Method of measurement: enzymatic mehod

Secondary outcomes

1

Description: weight
Timepoint: before the intervention and 12 weeks after
Method of measurement: scale (seca)

2

Description: BMI
Timepoint: before the intervention and 12 weeks after
Method of measurement: weight (kg) divided to height square

3

Description: visceral adiposity index
Timepoint: before the intervention and 12 weeks after
Method of measurement: formula based on these variables: BMI, waist circumference, HDL-C and triglyceride (TG)

4

Description: aspartate aminotransferase (AST)
Timepoint: before the intervention and 12 weeks after
Method of measurement: enzymatic method

5

Description: alanine aminotransferase (ALT)
Timepoint: before the intervention and 12 weeks after
Method of measurement: enzymatic method

6

Description: model-insulin resistance index (HOMA-IR)
Timepoint: before the intervention and 12 weeks after
Method of measurement: HOMA= fasting serum insulin (μU/ml)× fasting plasma glucose (mM/L)/22.5

7

Description: body fat percentage
Timepoint: before the intervention and 12 weeks after
Method of measurement: BIA

Intervention groups

1

Description: Intervention group: 1000 miligram of chitosan supplement (chitosan dose:500 miligram; twice a day)
Category: Lifestyle

2

Description: control group: 1000 miligram placebo
Category: Lifestyle

Recruitment centers

1

Recruitment center: Name of recruitment center

Golestan Hospital of Ahvaz

Full name of responsible person

Hedieh Rahmani

Street address

Ahvaz jundishapur university of medical sciences, Golestan Hospital, Ahvaz

City

Ahvaz

Province

Khouzestan

Postal code

61357-15794

Email

rahmani.he@ajums.ac.ir

1

Sponsor: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Dr. Mohammad Badavi

Street address

Jundishapur university of medical sciences, Golestan Ave, Ahvaz, Khuzestan, Iran

City

Ahvaz

Province

Khouzestan

Postal code

61357-15794

Phone

+98 61 3373 8317

Email

rahmani.he@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Ahvaz University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Hedieh Rahmani

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Nutrition

Street address

Ahvaz Jundishapur university of medical sciences, Golestan Ave, Ahvaz, Khuzestan

City

Ahvaz

Province

Khouzestan

Postal code

61357-15794

Phone

+98 61 3373 8317

Email

rahmani.he@ajums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Dr. Bizhan Helli

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Nutrition

Street address

Ahvaz Jundishapur university of medical sciences, Golestan Ave, Ahvaz, Khuzestan

City

Ahvaz

Province

Khouzestan

Postal code

61357-15794

Phone

+98 61 3373 8317

Email

bizahnhelli@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Hedieh Rahmani

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Nutrition

Street address

Ahvaz Jundishapur university of medical sciences, Golestan Ave

City

Ahvaz

Province

Khouzestan

Postal code

61357-15794

Phone

+98 61 3373 8317

Email

rahmani.he@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document: -
When the data will become available and for how long: -
To whom data/document is available: -
Under which criteria data/document could be used: -
From where data/document is obtainable: -
What processes are involved for a request to access data/document: -
Comments: -

The effect of chitosan supplementation on changes of body weight, glycemic risk factors (fasting glucose, insulin, glycated hemoglobin), lipid profile and visceral adiposity index in patients with nonalcoholic fatty liver disease (NAFLD)