Nonalcoholic Fatty Liver DiseaseNCT04845373
Effect of Mediterranean Diet in Obese Adolescents With Nonalcoholic Fatty Liver Disease
A study testing Mediterranean diet in people with Nonalcoholic Fatty Liver Disease, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effects of mediterranean and low-fat diet on hepatic fat, inflammation markers and oxidative stress in adolescents with nonalcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- What is being tested?
- Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2020to 29 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being between the ages of 11-18
- Being obese (BMI ≥95.persentil)
- Getting a diagnosis of Grade≥1 NAFLD
Who cannot join
- Existence of liver disease (wilson,hepatitis etc.) other than NAFLD
- Drinking alcohol
- Having a history of type 1 and type 2 diabetes
- Using drugs that can cause steatosis
- Using lipid-lowering drugs
- Using weight loss medications
Show all 15Show fewer
- Having applied dietary therapy for any disease and weight loss
- Existence of a chronic inflammatory disease
- Existence of cancer
- Thyroid dysfunction (hyperthyroid and hypothyroidism)
- Existence of a history of hepatic virus infection
- Having a history of parenteral nutrition
- Being pregnant and breastfeeding
- Receiving antibiotic treatment within 3 months prior to the study
- Regularly consuming foods containing probiotic and prebiotic properties and / or using nutritional supplements
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Tepecik Training and Research Hospital
Izmir
About this study
Official title: The Effect of Mediterranean Diet and Low Fat Diet on Hepatic Fat, Inflammation and Oxidative Stress in Obese Adolescents With Nonalcoholic Fatty Liver Disease
The aim of this study was to evaluate the effects of mediterranean and low-fat diet on hepatic fat, inflammation markers and oxidative stress in adolescents with nonalcoholic fatty liver disease. This randomized, single-blind controlled study conducted with obese adolescents aged 11-18 years who were admitted to Tepecik Training and Research Hospital Pediatric Gastroenterology Outpatient Clinic with the diagnosis of nonalcoholic fatty liver disease. Participants were randomly assigned to the Mediterranean diet or low-fat diet group.
Read the detailed description
This study was conducted to evaluate the effect of Mediterranean and low-fat diet on hepatic fat, inflammation and oxidative stress in obese adolescents with nonalcoholic fatty liver disease (NAFLD). The study, which was designed as a single blind randomized control, was completed with 44 obese adolescents diagnosed with NAFLD between the ages of 11-18. Adolescents were randomized to either a Mediterranean diet (n = 22) or a low-fat diet (control diet) (n = 22) for 12 weeks. At the beginning of the study and at the 12th week, adolescents' blood samples, physical activity and food consumption records were taken, anthropometric measurements and body composition analyzes were made, and antioxidant food consumption frequency and Mediterranean diet quality index questionnaire were applied to adolescents. In the controls performed at the 2th, 4th, 6th, 8th, and 10th weeks, the physical activity and food consumption records of the adolescents were repeated and anthropometric measurements and body composition analyzes were made again.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- Mediterranean diet, Control diet: Low fat diet
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietOther
Diet intervention:Mediterranean diet
Control diet: Low fat dietOther
Low fat diet
| Study group | Role | What they receive |
|---|---|---|
| Mediterrenean diet | Experimental | Mediterranean diet:Target macronutrient energy contributions were 40% from carbohydrate, 35%-40% from fat (with <10% of energy as saturated fat), and 20% of energy as protein.Participant in this group were trained to consume fish, legumes at least 2-3 times a week, walnuts and olive oil every day in accordance with the Mediterranean diet model. Receives: Other: Mediterranean diet |
| Low fat diet | Active comparator | Low fat diet:Target macronutrient energy contributions for the low fat diet diet were 50-60% from carbohydrate, <30% from fat (with <10% of energy as saturated fat), and 20% from protein.Participants in this group were especially recommended to consume low-fat foods. Receives: Other: Control diet: Low fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hepatic steatosis
Hepatic steatosis was evaluated according to liver ultrasonography records during the routine controls of all patients.
Measured: Baseline and week 12
Changes in Inflammatory Parameters
Measurement of serum cytokines levels (C-reaktive protein (CRP), IL-10, IL-6, IL-8, IL-1 beta, TNF-alpha
Measured: Baseline and week 12
Changes in oxidative stress markers
Measurement of oxidative stress markers (Total Antioxidant Status (TAS), Total Oxidant Status (TOS), Paraoxonase Enzyme Activity (PON-1), Total Thiol, Native Thiol, Superoxide Dismutase (SOD), oxidized-LDL, Glutathione peroxidase,Malondialdehyde (MDA), Glutathione (GSH), non-esterified fatty acids (NEFA))
Measured: Baseline and week 12
Changes in glycemic profile
Measurement of fasting glucose, insulin, HbA1c and calculation of HOMA-IR
Measured: Baseline and week 12
Changes in liver function tests
Measurement of Alanine transaminase (ALT),Aspartate transaminase (AST),Gamma-glutamyltransferase (GGT),Alkaline phosphatase (ALP)
Measured: Baseline and week 12
Secondary outcomes (7)
Changes in serum cholesterol levels
Measurement of total cholesterol, LDL, HDL cholesterol
Measured: Baseline and week 12
Changes in triglycerides
Measurement of serum triglyceride (mg/dl)
Measured: Baseline and week 12
Changes in blood pressure
Measurement of systolic and diastolic blood pressure (mm Hg)
Measured: Baseline and week 12
Changes in waist, hip and neck circumference
Measurement of waist circumference (cm)
Measured: baseline, week 2, week 4, week 6, week 8, week 10 and week 12
Changes in Body Fat
Measurement of % body fat with BIA
Measured: baseline, week 2, week 4, week 6, week 8, week 10 and week 12
Changes in BMI
weight and height will be measured to report BMI in kg/m2
Measured: baseline, week 2, week 4, week 6, week 8, week 10 and week 12
Changes in some adipokines
Measurement of serum leptin and adiponectin
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start5 Jan 2020
- Primary completion29 Nov 2020
- Study completion29 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Katip Celebi University
- Responsible party
- Principal investigator, GAMZE YURTDAŞ, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845373
- Sponsor's protocol ID
- 47/2020-05
- Status last verified
- Apr 2021
- First submitted
- 13 Nov 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yurtdas G, Akbulut G, Baran M, Yilmaz C. The effects of Mediterranean diet on hepatic steatosis, oxidative stress, and inflammation in adolescents with non-alcoholic fatty liver disease: A randomized controlled trial. Pediatr Obes. 2022 Apr;17(4):e12872. doi: 10.1111/ijpo.12872. Epub 2021 Dec 8.
PubMed 34881510
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mediterranean Diet and Low Fat Diet on Hepatic Fat, Inflammation and Oxidative Stress in Obese Adolescents With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04845373
- Acronym / sponsor ID
- 47/2020-05
- Conditions
- Nonalcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Izmir Katip Celebi University
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 29 Nov 2020 (actual)
- Study completion
- 29 Nov 2020 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate the effects of mediterranean and low-fat diet on hepatic fat, inflammation markers and oxidative stress in adolescents with nonalcoholic fatty liver disease. This randomized, single-blind controlled study conducted with obese adolescents aged 11-18 years who were admitted to Tepecik Training and Research Hospital Pediatric Gastroenterology Outpatient Clinic with the diagnosis of nonalcoholic fatty liver disease. Participants were randomly assigned to the Mediterranean diet or low-fat diet group.
Detailed description
This study was conducted to evaluate the effect of Mediterranean and low-fat diet on hepatic fat, inflammation and oxidative stress in obese adolescents with nonalcoholic fatty liver disease (NAFLD). The study, which was designed as a single blind randomized control, was completed with 44 obese adolescents diagnosed with NAFLD between the ages of 11-18. Adolescents were randomized to either a Mediterranean diet (n = 22) or a low-fat diet (control diet) (n = 22) for 12 weeks. At the beginning of the study and at the 12th week, adolescents' blood samples, physical activity and food consumption records were taken, anthropometric measurements and body composition analyzes were made, and antioxidant food consumption frequency and Mediterranean diet quality index questionnaire were applied to adolescents. In the controls performed at the 2th, 4th, 6th, 8th, and 10th weeks, the physical activity and food consumption records of the adolescents were repeated and anthropometric measurements and body composition analyzes were made again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterrenean diet | Experimental | Other: Mediterranean dietMediterranean diet:Target macronutrient energy contributions were 40% from carbohydrate, 35%-40% from fat (with <10% of energy as saturated fat), and 20% of energy as protein.Participant in this group were trained to consume fish, legumes at least 2-3 times a week, walnuts and olive oil every day in accordance with the Mediterranean diet model. |
| Low fat diet | Active comparator | Other: Control diet: Low fat dietLow fat diet:Target macronutrient energy contributions for the low fat diet diet were 50-60% from carbohydrate, <30% from fat (with <10% of energy as saturated fat), and 20% from protein.Participants in this group were especially recommended to consume low-fat foods. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Being between the ages of 11-18
- Being obese (BMI ≥95.persentil)
- Getting a diagnosis of Grade≥1 NAFLD
Key exclusion criteria (15 listed)
- Existence of liver disease (wilson,hepatitis etc.) other than NAFLD
- Drinking alcohol
- Having a history of type 1 and type 2 diabetes
- Using drugs that can cause steatosis
- Using lipid-lowering drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean dietDiet intervention:Mediterranean diet | Other | Mediterrenean diet |
| Control diet: Low fat dietLow fat diet | Other | Low fat diet |
Primary outcome
Changes in hepatic steatosis
Time frame: Baseline and week 12
Hepatic steatosis was evaluated according to liver ultrasonography records during the routine controls of all patients.
Changes in Inflammatory Parameters
Time frame: Baseline and week 12
Measurement of serum cytokines levels (C-reaktive protein (CRP), IL-10, IL-6, IL-8, IL-1 beta, TNF-alpha
Changes in oxidative stress markers
Time frame: Baseline and week 12
Measurement of oxidative stress markers (Total Antioxidant Status (TAS), Total Oxidant Status (TOS), Paraoxonase Enzyme Activity (PON-1), Total Thiol, Native Thiol, Superoxide Dismutase (SOD), oxidized-LDL, Glutathione peroxidase,Malondialdehyde (MDA), Glutathione (GSH), non-esterified fatty acids (NEFA))
Changes in glycemic profile
Time frame: Baseline and week 12
Measurement of fasting glucose, insulin, HbA1c and calculation of HOMA-IR
Changes in liver function tests
Time frame: Baseline and week 12
Measurement of Alanine transaminase (ALT),Aspartate transaminase (AST),Gamma-glutamyltransferase (GGT),Alkaline phosphatase (ALP)
7 secondary outcomes
Changes in serum cholesterol levels
Time frame: Baseline and week 12
Changes in triglycerides
Time frame: Baseline and week 12
Changes in blood pressure
Time frame: Baseline and week 12
Changes in waist, hip and neck circumference
Time frame: baseline, week 2, week 4, week 6, week 8, week 10 and week 12
Changes in Body Fat
Time frame: baseline, week 2, week 4, week 6, week 8, week 10 and week 12
Changes in BMI
Time frame: baseline, week 2, week 4, week 6, week 8, week 10 and week 12
Changes in some adipokines
Time frame: Baseline and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Derived from this study: PubMed 34881510Yurtdas G, Akbulut G, Baran M, Yilmaz C. The effects of Mediterranean diet on hepatic steatosis, oxidative stress, and inflammation in adolescents with non-alcoholic fatty liver disease: A randomized controlled trial. Pediatr Obes. 2022 Apr;17(4):e12872. doi: 10.1111/ijpo.12872. Epub 2021 Dec 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet in people with Nonalcoholic Fatty Liver Disease, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in hepatic steatosis (time frame: Baseline and week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04845373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.