Comparison of the effects of Sumac supplementation plus calorie-restricted diet versus calorie-restricted diet alone on inflammatory markers, oxidative stress, and fasting blood glucose in patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
This study is designed to investigate the effects of sumac on inflammatory status, oxidative stress, and glycemic indices in individuals with non-alcoholic fatty liver disease (NAFLD).
Design
A phase 3, double-blind, randomized, parallel-group controlled clinical trial on 62 patients. Stratified blocks will be used for randomization.
Settings and conduct
Study location: Nutrition Clinic, Allameh Behlool Gonabadi Hospital, Gonabad.
Study population: 62 patients receiving medical treatment.
Type of blinding: Double-blind.
Blinding procedure: Pills will be pre-coded as A and B by someone other than the researcher to keep both the researcher and patients unaware of their contents.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Presence of hepatic fat accumulation on liver ultrasound and grade 2 fatty liver disease; elevated liver enzymes (ALT and AST > 40 U/L); age between 20 and 60 years; body mass index (BMI) greater than 25 kg/m²; ability to read and write.
Exclusion criteria:
History of chronic diseases such as diabetes, cardiovascular, or kidney disorders; use of dietary supplements or herbal medicines within the past three months; pregnancy; lactation; use of medications that affect liver function; known allergy to sumac or related products.
Intervention groups
Intervention group: Participants will receive standard medical treatment under internist supervision and will take 1500 mg of sumac supplement daily, divided into three 500 mg doses, for 12 weeks.
Control group: Participants will receive standard medical treatment under internist supervision and will take 1500 mg of placebo (corn starch) daily, divided into three 500 mg doses, for 12 weeks.
Comparison of the effects of Sumac supplementation plus calorie-restricted diet versus calorie-restricted diet alone on inflammatory markers, oxidative stress, and fasting blood glucose in patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
Public title
The Effect of Sumac and a Low-Calorie Diet on Improving Fatty Liver Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals aged 20 to 60 years
Presence of fat accumulation in liver ultrasound evaluation with Grade 2 fatty liver and elevated liver enzymes (ALT and AST > 40)
Ability to read and write
Body Mass Index (BMI) greater than 25 kg/m²
Exclusion criteria:
Having chronic lung diseases, other liver diseases, heart conditions, and any chronic kidney or digestive disease
History of drinking alcoholic beverages
Smoking and drug abuse
Use of diuretics and nonsteroidal anti-inflammatory drugs (NSAIDs), estrogen, tamoxifen, corticosteroids, and blood sugar-lowering drugs within 3 weeks before the start of the study and during the study
Evidence of viral hepatitis infection
Pregnancy
Breast feeding
Follow of special diet
Regular consumption of antioxidant supplements such as vitamins E, C, and silymarin
Age
From 20 years old to 60 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate participants into the intervention group (receiving sumac supplement) and the control group (receiving placebo), stratified block randomization will be used. Stratification will be based on body mass index (BMI: <30 or ≥30 kg/m²) and gender (male or female) to ensure balanced distribution within each stratum.
A list of eligible participants will be prepared, and each individual will be categorized into one of four strata: female with BMI<30, female with BMI≥30, male with BMI<30, and male with BMI≥30. Then, within each stratum, participants will be randomly assigned to either group using Randomization.com (available at: https://www.randomization.com) with a block size of 4.
The randomization list will only be accessible to the researcher responsible for allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
To ensure proper blinding, the supplement and placebo will be identical in color, size, and odor, and neither the participants nor the researchers except for the pharmacist will be aware of their contents until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Gonabad University of Medical Sciences
Street address
Mehdizadeh boulevard
City
Gonabad
Province
Razavi Khorasan
Postal code
9691699967
Approval date
2025-01-18, 1403/10/29
Ethics committee reference number
IR.GMU.REC.1403.114
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver
ICD-10 code
K75
ICD-10 code description
Other inflammatory liver diseases
Primary outcomes
1
Description
Oxidative stress status (MDA)
Timepoint
Initially and 12 weeks (84 days) after starting sumac supplementation
Method of measurement
ELISA Kit
2
Description
Blood glucose
Timepoint
Initially and 12 weeks (84 days) after starting sumac supplementation
Method of measurement
Biochemical kit
3
Description
C reactive protein
Timepoint
Initially and 12 weeks (84 days) after starting sumac supplementation
Method of measurement
ELISA Kit
4
Description
Tumor Necrosis Factor alpha (TNF-α)
Timepoint
Initially and 12 weeks (84 days) after starting sumac supplementation
Method of measurement
ELISA Kit
5
Description
Interleukin 10 (IL-10)
Timepoint
Initially and 12 weeks (84 days) after starting sumac supplementation
Method of measurement
ELISA Kit
6
Description
Total antioxidant capacity (TAC)
Timepoint
Initially and 12 weeks (84 days) after starting sumac supplementation
Method of measurement
ELISA Kit
Secondary outcomes
1
Description
Alanine aminotransferase
Timepoint
Initially and 12 weeks (84 days) after starting sumac supplementation
Method of measurement
Biochemical kit
2
Description
Aspartate aminotransferase
Timepoint
Initially and 12 weeks (84 days) after starting sumac supplementation
Method of measurement
Biochemical kit
Intervention groups
1
Description
Intervention group: 1500 mg of Sumac powder supplement daily in three divided doses of 500 mg for 12 weeks
Category
Treatment - Other
2
Description
Control group: 500 mg daily of placebo (corn starch) with a color and odor similar to sumac, daily in three divided doses of 500 mg for 12 weeks
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Elyas Nattagh Eshtivani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mehdizadeh Blv
City
Gonabad
Province
Razavi Khorasan
Postal code
9691874359
Phone
+98 51 5722 5027
Email
nattagh.elyas@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Elyas Nattagh Eshtivani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mehdizadeh Blv
City
Gonabad
Province
Razavi Khorasan
Postal code
9691874359
Phone
+98 51 5722 5027
Email
nattagh.elyas@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Elyas Nattagh Eshtivani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mehdizadeh Blv
City
Gonabad
Province
Razavi Khorasan
Postal code
9691874359
Phone
+98 51 5722 5027
Email
nattagh.elyas@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
After completion of the study and publication of the results, the raw data will be made available to interested researchers upon request. Access will be provided through direct contact with the corresponding author and subject to approval by the ethics committee.
When the data will become available and for how long
After the project is completed (6 months after the results are published)
To whom data/document is available
Only for researchers working in academic institutions
Under which criteria data/document could be used
People working in research centers.
From where data/document is obtainable
Sending request to email: nattagh.elyas@gmail.com
What processes are involved for a request to access data/document