Evaluation of the Combined Effects of Flaxseed Consumption and Fasting Mimicking Diet (FMD) on Anthropometric Indices, Blood Lipid Composition, Glycemic Control, Inflammatory Markers, Steatosis and Hepatic Fibrosis in Patients with Non-Alcoholic Fatty Liver Diseases (NAFLD): a Randomized Control Trial
Determine the Effects of Flaxseed Consumption and Fasting Mimicking Diet on Patients with Non-Alcoholic Fatty Liver Diseases
Design
This research is a randomized clinical trial.
Settings and conduct
People were selected from those who were referred to the medical centers who had the conditions to enter the study, and after performing the fibroscan test and receiving consent from them, the people were randomly divided into four groups. At the beginning and end of the study, the desired questionnaires and blood samples will be received.
Participants/Inclusion and exclusion criteria
Entry conditions: age over 18 years, with evidence of non-alcoholic steatohepatitis with a Controlled Attenuation Parameter score above 263, without chronic inflammatory disease; body mass index above 25.
Conditions of non-entry: history of cancer, kidney disease, diabetes, cardiovascular diseases and digestive disorders affecting absorption, weight loss of more than 8% in the last 6 months and history of drug and alcohol use and hepatotoxic drugs.
Intervention groups
1- Control.
2- 16:8 fasting-mimicking diet: 16 hours a day in a fasting-mimicking mode and 8 hours of the usual diet.
3- Consumption of flaxseed (30 gr/day).
4- 16:8 fasting-mimicking diet + flaxseed consumption
Main outcome variables
Serum triglycerides
Total serum cholesterol
Serum LDL-C
Serum HDL-C
Serum ALT
Serum GGT
Serum AST
Serum hs-CRP
Hepatic steatosis
The extent of liver fibrosis
blood pressure
serum glucose
Serum insulin
Insulin resistance (HOMA-IR)
HbA1C
Quantitative index of insulin sensitivity(QUICKI)
Anthropometric indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100524004010N36
Registration date:2023-03-14, 1401/12/23
Registration timing:registered_while_recruiting
Last update:2023-03-14, 1401/12/23
Update count:0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-12, 1401/12/21
Expected recruitment end date
2023-06-11, 1402/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Combined Effects of Flaxseed Consumption and Fasting Mimicking Diet (FMD) on Anthropometric Indices, Blood Lipid Composition, Glycemic Control, Inflammatory Markers, Steatosis and Hepatic Fibrosis in Patients with Non-Alcoholic Fatty Liver Diseases (NAFLD): a Randomized Control Trial
Public title
Evaluation of the Combined Effects of Flaxseed Consumption and Fasting Mimicking Diet (FMD) on Patients with Non-Alcoholic Fatty Liver Diseases (NAFLD): a Randomized Control Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Having evidence of non-alcoholic steatohepatitis and CAP score over 263
Not having a history of alcohol and drug abuse
Absence of other chronic and acute liver disorders
No use of chemical and herbal medicines that affect the liver and weight
Not having a chronic inflammatory disease and no history of cancer
No treatment with anti-inflammatory drugs, corticosteroids and hormones
Not having lost more than 8 percent of the weight in the last 6 months
Blood pressure less than 140/90 mmHg
Not having uncontrolled kidney disease, pituitary disorders, thyroid, cardiovascular diseases, diabetes and digestive system disorders that affect absorption
No history of excessive consumption of flaxseed
Not having clinically diagnosed psychiatric disorders that impair the patient's ability to provide written informed consent
Willingness to participate in the study
Exclusion criteria:
Having clinically diagnosed psychiatric disorders that impair the patient's ability to provide written informed consent
Use of other supplements
Unwillingness to participate in the study
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 100 patients with non-alcoholic fatty liver, over 18 years of age, were randomized for 12 weeks by the simple randomized method according to the table of four random numbers and after stratification for BMI (1-range 25 to 29 and 2 - 30 and above) in four groups:
1- Control (nutritional recommendations to control the disease)
2- 16:8 fasting-mimicking diet: 16 hours a day in a fasting-mimicking mode and 8 hours of the usual diet.
3- Consumption of flaxseed (nutritional recommendations for disease control)
4- 16:8 fasting-mimicking diet + flaxseed consumption: 16 hours a day in a fasting-mimicking mode and 8 hours of usual diet plus the consumption of flaxseed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute (NNFTRI)
At the beginning of the study and at the end of the study (after 3 months)
Method of measurement
blood sample
9
Description
Serum glucose concentration
Timepoint
At the beginning of the study and at the end of the study (after 3 months)
Method of measurement
blood sample
10
Description
HbA1C
Timepoint
At the beginning of the study and at the end of the study (after 3 months)
Method of measurement
blood sample
Intervention groups
1
Description
The first intervention group: (Fasting mimicking diet 16/8): the people were given nutritional recommendations to control the disease and a person is in a fasting mimicking mode for 16 hours a day.
Category
N/A
2
Description
The second intervention group (consumption of flaxseed): the people were given nutritional recommendations to control the disease and they consumed 30 grams of flaxseed daily in 8 hours that are not fast.
Category
N/A
3
Description
The third intervention group (fasting mimicking diet 16/8 + flaxseed consumption): the people were given nutritional recommendations to control the disease, and the person was in a fasting mimicking mode for 16 hours a day and 8 hours of the usual diet plus the consumption of flaxseeds.
Category
N/A
4
Description
Control group: They follow the nutritional recommendations to control the disease.