Evaluation of the effects of Chia seeds (Salvia hispanica) on nutritional status, metabolic factors, liver function, inflammatory hematologic and atherogenic indices in obese patients with non-alcoholic fatty liver disease
To determine the effects of Chia seeds on nutritional status, metabolic factors, liver function, inflammatory hematologic and atherogenic indices in obese patients with non-alcoholic fatty liver disease
Design
A single-blind, controlled, randomized clinical trial using random assignment software (RAS) and randomized block method on 38 patients.
Settings and conduct
Study location: Tabriz University of Medical Sciences Nutrition Science Research Center; Study population: patients with non-alcoholic fatty liver disease; blinding: single-blind, in this study, the person who analyzes is blinded; A research assistant not otherwise involved in the study, will randomly allocate the participants into one of the two experimental groups (1:1), using the Random allocation software (RAS) and randomized block procedure. The person (completely unrelated to the study) who will prepare the supplement sachets will assigne a 3-digit code for each treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: both genders; age 18 to 60 years; body mass index 30- 39.9 Kg/m; hepatic steatosis; willing to participate in the study.
Exclusion criteria: athletes; pregnancy; breastfeeding and menopause; following a special diet; taking medications for weight-reducing or any other medications affecting liver function for 3 months before or during the study; suffering from certain diseases
Intervention groups
The intervention group will receive two- 20 gr sachets of chia seeds per day along with weight loss diet while the control group will only receive weight loss diet
Main outcome variables
Nutritional status (intake of energy and macronutrients, appetite status); Anthropometric indices and body composition;
Metabolic factors;
Liver function and liver fibrosis score;
Hematological indicators of inflammation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100209003320N23
Registration date:2024-01-30, 1402/11/10
Registration timing:prospective
Last update:2024-01-30, 1402/11/10
Update count:0
Registration date
2024-01-30, 1402/11/10
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Chia seeds (Salvia hispanica) on nutritional status, metabolic factors, liver function, inflammatory hematologic and atherogenic indices in obese patients with non-alcoholic fatty liver disease
Public title
The effect of chia seeds on non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both genders
Age range of 18 to 60 years
body mass index= 30- 39.9 Kg/m2
Hepatic steatosis based on ultrasound findings (grade 1 and 2)
willingness to participate in the study
Exclusion criteria:
Athletes
pregnancy
breastfeeding
menopause
Under infertility treatment
taking birth control pills
estrogen therapy
Smoking
history of alcohol consumption
Taking medications including chemical or herbal medications for weight loss
anti-hypertensive
Fat-lowering drugs
Sugar-lowering drugs
any nutritional supplements from 3 months before the study
Having cardiovascular diseases
Liver dysfunction
Kidney dysfunction
Intestinal dysfunction
Thyroid dysfunction
Parathyroid dysfunction
known autoimmune diseases
polycystic ovary syndrome
cancers
Following a special diet in the last three months
performing weight loss surgery in the last one year
Taking Phenytoin medicine
Taking amoxifene medicine
Taking lithium medicine
Performing or being a candidate for liver transplantation
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
A research assistant not otherwise involved in the study,
will randomly allocate 38 patients into one of the two
experimental groups (1:1), using the Random allocation
software (RAS) and randomized block procedure (age (18-39 vs 39-60 years)- gender (female vs male) and BMI
(<35 kg/m2 vs. ≥35 kg/m2)).
Blinding (investigator's opinion)
Single blinded
Blinding description
A research assistant not otherwise involved in the study, randomly allocated the participants into one of the two experimental groups (1:1), using the Random allocation software (RAS) and randomized block procedure. The person (completely unrelated to the study) who will prepare the supplement sachets will assigne a 3-digit code for each treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
IR.TBZMED.REC.1402.751
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Insulin
Timepoint
Baseline and after 8 weeks
Method of measurement
ELISA method
2
Description
Hemoglobin A1C
Timepoint
Baseline and after 8 weeks
Method of measurement
chromatography
3
Description
total cholesterol
Timepoint
Baseline and after 8 weeks
Method of measurement
Enzymatic method
4
Description
Triglyceride
Timepoint
Baseline and after 8 weeks
Method of measurement
Enzymatic method
5
Description
HDL cholesterol
Timepoint
Baseline and after 8 weeks
Method of measurement
Enzymatic-colorimetric method using spectrophotometer
6
Description
LDL cholesterol
Timepoint
Baseline and after 8 weeks
Method of measurement
Based on the ّFriedelwald formula
7
Description
Insulin resistance indices (HOMA-IR, HOMA-B and QUICKI)
Timepoint
Baseline and after 8 weeks
Method of measurement
Based on the formula
8
Description
Body mass index(BMI)
Timepoint
Baseline and after 8 weeks
Method of measurement
Based on the formula
9
Description
Waist circumference
Timepoint
Baseline and after 8 weeks
Method of measurement
tape measure
10
Description
Waist to hips ratio (WHR)
Timepoint
Baseline and after 8 weeks
Method of measurement
Based on the formula
11
Description
Waist to Height ratio (WHTR)
Timepoint
Baseline and after 8 weeks
Method of measurement
Based on the formula
12
Description
Fat mass
Timepoint
Baseline and after 8 weeks
Method of measurement
Body analyzer
13
Description
Fat Free mass
Timepoint
Baseline and after 8 weeks
Method of measurement
Body analyzer
14
Description
Energy, macronutrients and micronutrients intake
Timepoint
Baseline and after 8 weeks
Method of measurement
24- hr food recall questionnaire for 3 days and Nutritionist 4 software
15
Description
Physical activity level
Timepoint
Baseline and after 8 weeks
Method of measurement
IPAQ Questionnaire- short form
16
Description
Appetite status
Timepoint
Baseline and after 8 weeks
Method of measurement
Validated appetite questionnaire
17
Description
Body weight
Timepoint
Baseline and after 8 weeks
Method of measurement
Scale
18
Description
Fasting glucose
Timepoint
Baseline and after 8 weeks
Method of measurement
Enzymatic method
19
Description
Complete blood cell count (CBC)
Timepoint
Baseline and after 8 weeks
Method of measurement
Coulter counter
20
Description
Serum Albumin
Timepoint
Baseline and after 8 weeks
Method of measurement
using BROMOCRESOL GREEN
21
Description
Platelets count
Timepoint
Baseline and after 8 weeks
Method of measurement
Coulter counter
22
Description
Liver fibrosis score
Timepoint
Baseline and after 8 weeks
Method of measurement
based on formula
23
Description
total body water
Timepoint
Baseline and after 8 weeks
Method of measurement
Using bioelectric impedance analyzer
24
Description
Hematological indicators of inflammation (the number of monocytes, neutrophils, lymphocytes and platelets in whole blood and the estimation of the ratios of monocytes, neutrophils and platelets to lymphocytes)
Timepoint
Baseline and after 8 weeks
Method of measurement
Coulter counter
25
Description
Atherogenic indices (LDL-C/HDL-C, TC/HLD-C, TG/HDL-C, nonHDL-C/HDL-C)
Timepoint
Baseline and after 8 weeks
Method of measurement
Based on the formula
26
Description
Hip circumference
Timepoint
Baseline and after 8 weeks
Method of measurement
tape measure
27
Description
Serum ferritin
Timepoint
Baseline and after 8 weeks
Method of measurement
Electrochemiluminescence method
Secondary outcomes
1
Description
Fatty liver grade
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Ultrasonigraphy findings
2
Description
Alanine aminotransferase (ALT)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic method
3
Description
Aspartate aminotransferase (AST)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic method
Intervention groups
1
Description
"Intervention group": patients in this group will receive chia seeds along with a weight loss diet, taking into account that 100 grams of chia seeds contain 486 calories (approximately 200 calories for 40 grams of chia seeds per day) to moderate the amount of weight loss Calories in the intervention group will be reduced by 700 kilocalories and to adjust the diet with the distribution of macronutrients as 55% carbohydrates, 30% fat, 15% protein. Daily, two 20-gram sachets of Paraguayan chia seeds will be purchased from Isfahan Herbal Company in sachet form. 20 grams will be packed, half an hour before two meals a day, and they will be consumed in a glass of lukewarm water. The duration of the study will be 8 weeks. People in the intervention group will be asked to bring unused sachets with them every two weeks to determine compliance. Weight control and distribution of sachets will be done every two weeks
Category
Treatment - Drugs
2
Description
"Control group": patients in this group will only receive a weight loss diet (500 kcal reduction) along with a glass of water before two main meals for 8 weeks.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Science
Full name of responsible person
Dr.Mehrangiz Ebrahimi- Mameghani
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
51666-14711
Phone
+98 41 3336 6215
Email
ebrahimimamagani@tbzmed.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
51666-14711
Phone
+98 41 3335 7582
Email
ebrahimimamagani@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimi- Mameghani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7584
Email
ebrahimimamagani@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimi- Mameghani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5185747731
Phone
+98 41 3335 7584
Email
ebrahimimamagani@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Parimi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7584
Email
maryam.parimi6@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
Data collected for the primary outcomes will be shared
When the data will become available and for how long
The access period starts 12 months after the results are published
To whom data/document is available
The data will be available only to people working in scientific institutions
Under which criteria data/document could be used
The data of this study will be available to other researchers only for meta-analysis studies
What processes are involved for a request to access data/document
The applicant should provide a brief explanation of the goals and methodology of his meta-analysis. The applicant's request will be reviewed and if approved, the data will be sent to the applicant via email. All these steps will not take more than 15 days