IRCT | Evaluating the Effect of Spirulina Consumption on Anthropometric, Glucose, Lipid, Antioxidant, Inflammatory indices and Liver Enzymes in Non-Alcoholic ّFatty Liver Patient.

Protocol summary

Study aim: Determination of the effect of Spirulina on anthropometric characteristics, inflammatory markers, oxidative stress, Homa index, blood pressure, lipid profile and liver enzymes in patients with fatty liver.
Design: A randomized controlled clinical trial with parallel, double-blind, randomized groups
Settings and conduct: The study population will be selected from patients with non-alcoholic fatty liver disease admitted to the clinics of Shiraz according to the inclusion criteria and the purpose and procedures for those eligible for inclusion will be fully explained and if applicable. The willingness of the study participants to complete the informed consent form will be completed. Participants were divided into two groups of intervention and control using block randomization
Participants/Inclusion and exclusion criteria: Non-alcoholic fatty liver disease, no malnutrition, no alcohol consumption, no blood lipid-lowering medication, no specific diets such as vegetarian and raw foods, no diabetes mellitus, cardiovascular disease, liver disease, no pregnancy and lactation, no drugs that cause fatty liver (methotrexate, tamoxifen, valproate, etc.)
Intervention groups: The intervention group will receive 2 grams of spirulina daily for 8 weeks and the control group will receive 2 grams of placebo daily for 8 weeks.
Main outcome variables: Anthropometric, glucose, lipid, antioxidant, inflammatory and liver enzymes indices

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200304046692N1

Registration date: 2020-03-11, 1398/12/21

Registration timing: retrospective

Last update: 2020-03-11, 1398/12/21

Update count: 0
Registration date: 2020-03-11, 1398/12/21

Registrant information: Name

Reza Barati-Boldaji

Name of organization / entity

Shiraz University of Medical Sciences

Country

Iran (Islamic Republic of)

Phone

+98 71 3225 7162

Email address

reza93barati@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2019-12-11, 1398/09/20
Expected recruitment end date: 2020-01-30, 1398/11/10
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Evaluating the Effect of Spirulina Consumption on Anthropometric, Glucose, Lipid, Antioxidant, Inflammatory indices and Liver Enzymes in Non-Alcoholic ّFatty Liver Patient.

Public title: Evaluating the effect of Spirulina in Non-alcoholic ّfatty liver patient.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Individuals with Non-alcoholic fatty liver disease

Exclusion criteria:

Individuals with malnutrition Individuals with alcohol consumption taking lipid-lowering drugs following special diets such as vegetarian or raw vegetarian diseases such as diabetes mellitus, cardiovascular disease, liver disease (cirrhosis, alcoholic liver disease, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, biliary obstruction, hepatic injury induced by hereditary hemochromatosis drugs, sclerosis cholangitis, and α antisense deficiency), cancer, renal failure, celiac; being in pregnancy and lactation. taking Drugs that cause fatty liver (methotrexate, tamoxifen, valproate, etc.)
Age: No age limit
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Investigator
Data analyser

Sample size

Target sample size: 46

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization of the two groups will be done by blocking method. The block size is set to 4 and all possible states for groups A and B are written and this is repeated until the number reaches 46. Then each component of the block is assigned a number using a random number table. The numbers given to each of the blocks represent the number assigned to each predefined number. This way the group assigned to each person is identified.

Blinding (investigator's opinion)

Double blinded

Blinding description

The designed placebo is completely similar in color to that of the intervention group. To help the blind, the researcher is assisted by someone who is not involved in the research process.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Baqyatallah University of Medical Sciences

Street address

Mulla Sadra Street, Vanak Square, Tehran

City

Tehran

Province

Tehran

Postal code

0
Approval date: 2020-01-13, 1398/10/23
Ethics committee reference number: IR.BMSU.REC.1398.312

Health conditions studied

1

Description of health condition studied: Non-alcoholic fatty liver
ICD-10 code: K76.0
ICD-10 code description: Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description: The degree of fatty liver
Timepoint: Before and after 8 weeks of intervention
Method of measurement: liver ultrasound

Secondary outcomes

1

Description: Anthropometric indices
Timepoint: Before and after 8 weeks of intervention
Method of measurement: Digital scales and tape meters

2

Description: Lipid profile
Timepoint: Before and after 8 weeks of intervention
Method of measurement: Kit

3

Description: Systolic and diastolic blood pressure
Timepoint: Before and after 8 weeks of intervention
Method of measurement: Mercury barometer

4

Description: Blood sugar indices
Timepoint: Before and after 8 weeks of intervention
Method of measurement: Kit

5

Description: inflammatory indices
Timepoint: Before and after 8 weeks of intervention
Method of measurement: enzyme-linked immunosorbent assay( ELISA)kit

6

Description: Liver enzymes
Timepoint: Before and after 8 weeks of intervention
Method of measurement: Kit

Intervention groups

1

Description: Intervention group: For 8 weeks, they will receive 2 grams of spirulina daily in form of the sauce prepared at the Shiraz Namakin Factory.Each 20g sauce sachet contains 2 grams of spirulina. At the beginning of the study, the number of sauces required will be delivered to each individual (30 sachets at the beginning of the first month and 30 sachets at the beginning of the second month). Individuals are asked to eat one sachet daily with food.
Category: Treatment - Other

2

Description: Control group: For 8 weeks, they will receive placebo daily in form of the sauce prepared at the Shiraz Namakin Factory with Edible color . At the beginning of the study, the number of sauces required will be delivered to each individual (30 sachets at the beginning of the first month and 30 sachets at the beginning of the second month). Individuals are asked to eat one sachet daily with food.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Motahari Clinic

Full name of responsible person

Reza Barati Boldaji

Street address

Namaz Square

City

Shiraz

Province

Fars

Postal code

0

Phone

+98 71 3612 2206

Email

reza93barati@gmail.com

1

Sponsor: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Dr. Younes Qasemi

Street address

Zand Blvd

City

Shiraz

Province

Fars

Postal code

0

Phone

+98 71 3612 2206

Email

reza93barati@gmail.con
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Shiraz 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

Shiraz University of Medical Sciences

Full name of responsible person

Reza Barati

Position

Researcher

Latest degree

Master

Other areas of specialty/work

Nutrition

Street address

Khalili Blvd

City

Shiraz

Province

Fars

Postal code

0

Phone

+98 71 3612 2206

Email

reza93barati@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Reza Barati

Position

Researcher

Latest degree

Master

Other areas of specialty/work

Nutrition

Street address

Khalili Blvd

City

Shiraz

Province

Fars

Postal code

0

Phone

+98 71 3612 2206

Email

reza93barati@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Reza barati

Position

Researcher

Latest degree

Master

Other areas of specialty/work

Nutrition

Street address

Khalili Blvd

City

Shiraz

Province

Fars

Postal code

0

Phone

+98 71 3612 2206

Email

reza93barati@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: All potential data can be shared after unidentifiable people
When the data will become available and for how long: Start of the access period, 6 months after printing results
To whom data/document is available: For researchers working only in academic and scientific institutions
Under which criteria data/document could be used: For use in research and publication of articles
From where data/document is obtainable: Reza Barati 0098 9132807850
What processes are involved for a request to access data/document: Initially contacting the researcher and expressing the request then reviewing the request by the researcher and finally sending the documentation if the researcher agrees
Comments

Evaluating the Effect of Spirulina Consumption on Anthropometric, Glucose, Lipid, Antioxidant, Inflammatory indices and Liver Enzymes in Non-Alcoholic ّFatty Liver Patient.