Effect of flaxseed on fatty liver disease in adolescents

ISRCTN ISRCTN15425217
DOI https://doi.org/10.1186/ISRCTN15425217
Submission date
20/07/2024
Registration date
29/07/2024
Last edited
29/07/2024
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Fatty liver is the most common chronic liver disease worldwide. Improvements in diet and physical activity are first-line therapy. Flaxseed is rich in polyunsaturated fatty acids, proteins of high biological value and antioxidant nutrients. Multiple studies in the adult population have shown that flaxseed ingestion improves the nutritional, hepatic and fat profiles.
The aim of this study is to analyze the effect of flaxseed on the Controlled Attenuation Parameter in adolescents with fatty liver.

Who can participate?
Adolescent patients aged 10 to 17 years, of any sex, with a diagnosis of fatty liver (with a diagnosis established by evidence of hepatic steatosis by ultrasonography), who also have overweight or obesity according to the World Health Organization (WHO) .Patients whose parents have a mobile phone. Patients that receive follow-up in the outpatient clinic for nutrition, pediatric endocrinology and pediatric gastroenterology areas of the Instituto Mexicano del Seguro Social, Unidad Médica de Alta Especialidad No. 48, Hospital de Gineco Pediatría, Centro Médico Nacional del Bajío.

What does the study involve?
The patients will be assigned into one of the two group studies, using a table with random numbers. Group 1 will receive recommendations in changes of lifestyle that include orientation over diet and physical activity alongside a cookie with flaxseed, every 24 hours before breakfast, for 12 weeks. Group 2 will receive recommendations in changes of lifestyle that include orientation over diet and physical activity alongside a wheat bran cookie every 24 hours before breakfast, for 12 weeks. Both cookies contain the same amount of fiber and protein in each.They will provide the same amount of energy.
At the beginning the patients will receive a 20-minute educational session with dietary guidance and recommendations to maintain the same type of routine physical activity; the patient will receive this information in writing.
In week 0 and week 12, the Controlled Attenuation Parameter will be evaluated in the patients of both groups. In both weeks 0 and 12, the researcher will do some questions on the patient to evaluate the Food Security.
In weeks 0, 6 and 12, researchers will evaluate the BMI of the patients, waist circumference, blood pressure and laboratory testing regarding the liver function, lipid profile and fasting glucose. The Frequency of Food Consumption survey will be applied on these patients at weeks 0, 6 and 12. On weeks 0, 6 and 12, a podometer will be given to patients to evaluate the amount of steps taken in a 5 day period.
After all the initial studies have been carried out, the patients will receive 1 weeks’ worth of cookies that correspond to their group and an appointment will be made once a week to give them a new supply. Patients will be instructed to eat one cookie daily before breakfast for 12 weeks.
At the weekly visit, a brief questionnaire will be carried out to assess attachment to eating the cookie and the patient will be asked to return the closed box empty or with the remains if the patient has not eaten all the cookies.
Parents or tutors will receive a brief phone call each Tuesday and Saturday motivating them to eat the cookies, and they will be interrogated about the presence of symptoms like diarrhea, abdominal pain, among others.

What are the possible benefits and risks of participating?
The possible benefits of participating are the following: the patient will receive information through the measurements that will be carried out on them that will allow monitoring of existing diseases and this will also allow timely measures, receiving care from the necessary specialists for their management. In addition, patients will receive in their diet 9 grams of fiber per day and 6 grams of protein per day, which will be part of their daily requirement.
The possible risks are the following: taking measurements on the patient’s body may cause them embarrassment by exposing their waist and abdomen. Taking a blood sample will cause pain that is considered mild and may leave a bruise. The intake of flaxseed or wheat bran in the quantities that will be given so far has no scientific evidence of any risk; however, it contains fiber so it can cause soft stools or abdominal pain. Researchers will monitor and, if necessary, will give medical attention, taking in consideration the suspension of the intake of these cookies.

Where is the study run from?
It will run at the Instituto Mexicano del Seguro Social, Unidad Médica de Alta Especialidad No. 48, Hospital de Gineco Pediatría, Centro Médico Nacional del Bajío, Street Paseo de los Insurgentes S/N, Col. Los Paraísos; at the city of León, from the state of Guanajuato, Mexico.

When is the study starting and how long is it expected to run for?
October 2023 to September 2025

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Mariana Gómez Nájera, marianagomeznajera@gmail.com

Contact information

Dr Mariana Gómez-Nájera
Principal Investigator

Street Bernese 108, Col. Lomas del Refugio
León
37358
Mexico

ORCiD logoORCID ID 0009-0009-3614-9572
Phone +52 4773526064
Email m.gomeznajera@ugto.mx
Dr Gloria Patricia Sosa-Bustamante
Public, Scientific

Street Fersen 106, Col. Lomas del Refugio
León
37358
Mexico

ORCiD logoORCID ID 0000-0002-8460-4965
Phone +52 4773931426
Email gloria.sosa@imss.gob.mx

Study information

Study designInterventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home, Hospital
Study typeTreatment
Participant information sheet 45815 PIS.pdf
Scientific titleEffect of flaxseed on Controlled Attenuation Parameter in adolescents with Metabolic Dysfunction-Associated Steatotic Liver Disease. Controlled Clinical Trial
Study acronymEFLXCAPMASLD
Study objectivesThe flaxseed has an effect on the controlled attenuation parameter in adolescents with metabolic dysfunction-associated steatotic liver disease.
Ethics approval(s)

Approved 01/07/2024, Local Board of Health Research 1002 (Street Paseo de los Insurgentes S/N, Col. Los Paraísos, León, 37320, Mexico; +52 477 7174 800; 10028hgp48@gmail.com), ref: R-2024-1002-041

Health condition(s) or problem(s) studiedMetabolic Dysfunction-Associated Steatotic Liver Disease in adolescents.
InterventionThe patients will be assigned into one of the two group studies, using a table with random numbers. Group 1 will receive recommendations in changes of lifestyle that include orientation over diet and physical activity alongside a cookie with flaxseed, every 24 hours before breakfast, for 12 weeks. Group 2 will receive recommendations in changes of lifestyle that include orientation over diet and physical activity alongside a wheat bran cookie every 24 hours before breakfast, for 12 weeks. Both cookies contain the same amount of fiber and protein in each.They’ll contribute the same amount of energy
At the beginning the patients will receive a 20-minute educational session with dietary guidance and recommendations to maintain the same type of routine physical activity; the patient will receive this information in writing.
In week 0 and week 12, the Controlled Attenuation Parameter will be evaluated in the patients of both groups. In both weeks 0 and 12, the researcher will do some questions on the patient to evaluate the Food Security.
In weeks 0, 6 and 12, researchers will evaluate the BMI of the patients, waist circumference, blood pressure and laboratory testing regarding the liver function, lipid profile and fasting glucose. The Frequency of Food Consumption survey will be applied on these patients at weeks 0, 6 and 12. On weeks 0, 6 and 12, a podometer will be given to patients to evaluate the amount of steps taken in a 5 day period.
After all the initial studies have been carried out, the patients will receive 1 weeks’ worth of cookies that correspond to their group and an appointment will be made once a week to give them a new supply. Patients will be instructed to eat one cookie daily before breakfast for 12 weeks.
At the weekly visit, a brief questionnaire will be carried out to assess attachment to eating the cookie and the patient will be asked to return the closed box empty or with the remains if the patient has not eaten all the cookies.
Parents or tutors will receive a brief phone call each Tuesday and Saturday motivating them to eat the cookies, and they will be interrogated about the presence of symptoms like diarrhea, abdominal pain, among others.
Intervention typeOther
Primary outcome measureControlled Attenuation Parameter will be measured with Fibroscan, at weeks 0 and 12
Secondary outcome measures1. In weeks 0, 6 and 12, the nutritional profile will be evaluated with the BMI, waist circumference, blood pressure and laboratory testing regarding the liver function (ALT, AST, GGT, LDH), lipid profile (LDL, HDL, cholesterol, tryglycerides) and fasting blood glucose
3. The Daily Intake of Energy will be evaluated with the Frequency of Food Consumption Survey at weeks 0, 6 and 12
4. On weeks 0, 6 and 12, physical activity will be evaluated with a podometer that will assess the average of the amount of steps taken in a 5 day period
5. Presence of adverse effects will be evaluated with the presence of any gastrointestinal symptoms like diarrhea or abdominal pain
Overall study start date01/10/2023
Completion date01/09/2025

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit10 Years
Upper age limit17 Years
SexBoth
Target number of participants50
Key inclusion criteria1. Adolescent patients, from ages 10 to 17, of any sex, with the diagnosis of Metabolic Dysfunction-Associated Steatotic Liver Disease
2. Adolescentes with an established diagnosis of Steatotic Liver disease by ultrasonography, presence of overweight or obesity according to the Z-score Z ≥1 BMI, with reference parameters of the WHO
3. Parents of the patient must have a phone number
4. Patients that receive follow-up at the outpatient consultation on the Nutrition, pediatric endocrinology and pediatric gastroenterology areas, at the Instituto Mexicano del Seguro Social, Unidad Médica de Alta Especialidad No. 48, Hospital de Gineco Pediatría, Centro Médico Nacional del Bajío
Key exclusion criteria1. Patients with the diagnosis of a previous Drug Induced Liver Injury, Viral Hepatitis B or C infection or HIV infection
2. Patients with alcohol ingestion greater than 140g per week in women or greater than 210g per week on men
3. History of Congenital hepatic disease, autoimmune diseases, primary hypothyroidism, psychiatric disorders or chronic kidney disease
4. Allergy to flaxseed or wheat
5. Patients treated with either one or more of the following medications: steroids, hypoglycemic agents, hypolipidemic agents, vitamin supplements, docosahexaenoic acid, eicosapentaenoic acid, antibiotics or herbal therapy
6. Patients with physical or sensorial disabilities
7. Pregnant or breastfeeding patients
Date of first enrolment01/09/2024
Date of final enrolment01/06/2025

Locations

Countries of recruitment

  • Mexico

Study participating centre

Instituto Mexicano del Seguro Social, Unidad Médica de Alta Especialidad No. 48, Hospital de Gineco Pediatría, Centro Médico Nacional del Bajío
Street Paseo de los Insurgentes S/N, Col. Los Paraísos
León
37320
Mexico

Sponsor information

Mexican Social Security Institute
Hospital/treatment centre

Street Paseo de los Insurgentes S/N, Col. Los paraísos
León
37320
Mexico

Phone +52 4777174800
Email gloria.sosa@imss.gob.mx
Website http://www.imss.gob.mx/
ROR logo "ROR" https://ror.org/03xddgg98

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/11/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from Mariana Gómez Nájera, at the following email address: marianagomeznajera@gmail.com

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other files Data capture sheet 29/07/2024 No No
Participant information sheet 29/07/2024 No Yes
Statistical Analysis Plan 29/07/2024 No No

Additional files

45815 Data capture sheet.pdf
Data capture sheet
45815 PIS.pdf
45815 SAP.pdf

Editorial Notes

22/07/2024: Trial's existence confirmed by Local Board of Health Research 1002.