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Effect of black garlic and garlic supplementation on cardiometabolic risk factors and fibroscan findings in patients with non-alcoholic fatty liver disease: a double-blind randomized controlled clinical trial

Protocol summary

Study aim
Determining the effect of garlic and black garlic supplementation on cardiometabolic and fibroscan indices in patients with nonalcoholic fatty liver disease
Design
After selecting the study subjects, the subjects will be divided into three groups: garlic, black garlic, and placebo (23 subjects in each group) in a 1:1 ratio using the block method. The blocks of six were created by the Random Allocation Software (RAS) statistical software and will be identified with the letters A, B, and C.
Settings and conduct
Patients in the intervention and placebo groups will receive 4 black garlic tablets each containing 500 mg of black garlic powder, 4 garlic tablets containing 500 mg of garlic powder, and 4 identical placebo tablets (two after breakfast and two after dinner) daily, respectively, along with dietary and physical activity recommendations. The capsules will be placed in containers and labeled by a third party in randomized blocks. Participants and care providers will be blinded to the intervention. Each patient will be assigned a code and will receive the capsules in the corresponding pre-packaged bottle.
Participants/Inclusion and exclusion criteria
Willingness to participate in the study Age 20-65 years Body mass index (BMI) 25 and above- Grade 1 to 3 hepatic steatosis diagnosed by ultrasound
Intervention groups
Patients in the intervention and placebo groups will receive 4 black garlic and garlic and placebo tablets daily along with dietary and physical activity recommendations. The capsules will be placed in containers and labeled by a third party based on random blocks. Participants and care providers will be blinded to the intervention.
Main outcome variables
Studying the effect of garlic and black garlic supplementation on cardiometabolic and fibroscan indices in patients with nonalcoholic fatty liver disease

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250608066122N1
Registration date: 2025-06-27, 1404/04/06
Registration timing: prospective

Last update: 2025-06-27, 1404/04/06
Update count: 0
Registration date
2025-06-27, 1404/04/06
Registrant information
Name
Soror Fathi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 547 1651
Email address
soroor.s1705@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-23, 1404/05/01
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of black garlic and garlic supplementation on cardiometabolic risk factors and fibroscan findings in patients with non-alcoholic fatty liver disease: a double-blind randomized controlled clinical trial
Public title
Effect of black garlic on patients with non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Performance to participate in the study Age 20-65 years Body mass index (BMI) 25 and above Performed by ultrasound method
Exclusion criteria:
Pregnancy and breastfeedingSmokingIntake of large amounts of garlic in daily food intakeTreatment of heart, lung, kidney diseases, hepatitis, cirrhosis, biliary and immune system disorders, high blood pressure, hypothyroidism, Cushing's syndromeUse of drugs for consumption and blood sugar, vitamins E and D, ursodeoxycholic acid, phenytoin, tamoxifen, lithium, corticosteroids and methotrexateWeight loss and bariatric surgery in the last yearGarlic reviewNo use of other herbal supplements in the last three months
Age
From 20 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the study subjects, the subjects will be divided into three groups: garlic, black garlic, and placebo (n = 1 in each group) in a 1:1 ratio using the block method. The blocks of six were created by the statistical software Random Allocation Software (RAS) and will be identified with the letters A, B, and C.
Blinding (investigator's opinion)
Double blinded
Blinding description
Since participants do not know which group they are in, their beliefs about the treatment do not affect the outcome, and since clinical caregivers do not know which group is actually receiving treatment, they are unable to influence the course of treatment by revealing small clues.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of ahvaz University of Medical Sciences
Street address
No. 18, 2Ave., beheshti Blvd., shahin shahr Town
City
Isfahan
Province
Isfehan
Postal code
8314895182
Approval date
1994-10-26, 1373/08/04
Ethics committee reference number
IR.AJUMS.REC.1404.164

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
Monitoring people with fatty liver disease
Timepoint
٬۰۰۰At the beginning of the study (before starting work) and 12 weeks later
Method of measurement
Fibroscan

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:black garlic
Category
Treatment - Other

2

Description
Intervention group: garlic
Category
Treatment - Other

3

Description
Control group: placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Milad hospital
Full name of responsible person
Soroor fathi
Street address
No. 18, 2 Ave., beheshti Blvd.,shahin shahr Town
City
Shahin shahr
Province
Isfehan
Postal code
8314895182
Phone
+98 31 4522 6525
Email
Soroor.s1705@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed ahmad hoseini
Street address
Golestan,ahvaz medical university
City
Ahvaz
Province
Khouzestan
Postal code
1234567890
Phone
+98 916 309 7944
Email
Seyedahmadhosseini@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Soroor fathi
Proportion provided by this source
70
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Soroor fathi
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 18 ,2 Ave., beheshti Blvd.,shahin shahr Town
City
Shahin shahr
Province
Isfehan
Postal code
8314895182
Phone
+98 31 4522 6525
Email
Soroor.s1705@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed ahmad hosseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan ave,ahvaz university medical sience
City
Ahvaz
Province
Khouzestan
Postal code
1234567890
Phone
+98 61 3311 2537
Email
Seyedahmadhosseini@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Soroor fathi
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 18 , 2 Ave., beheshti Blvd., shahin shahr Town
City
Shahin shahr
Province
Isfehan
Postal code
8314895182
Phone
+98 31 4522 6515
Email
Soroor.s1705@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Patient information is private and cannot be published to protect the information.
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
Undecided - It is not yet known if there will be 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
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