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Non-Alcoholic Fatty Liver DiseaseNCT05073588

Effect of Indo-Mediterranean Diet on Hepatic Steatosis and Fibrosis in NAFLD Children

A study testing Indo Mediterranean diet and Calorie restricted diet in people with Non-Alcoholic Fatty Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

NAFLD encompasses the entire spectrum of Fatty liver disease in individuals without significant alcohol consumption, ranging from fatty liver to steatohepatitis to cirrhosis. A high prevalence of NAFLD (62.5%) was observed in overweight/obese Indian adolescent. Read more about this study

Who is it for?
Ages 8 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Non-Alcoholic Fatty Liver Disease
What is being tested?
Indo Mediterranean diet and Calorie restricted diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteIndia
Study dates
16 Aug 2021to 30 Mar 2023
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 8 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Age 8-18 years
  • BMI > 85th centile
  • Ultrasonography abdomen s/o Fatty Liver
  • Biopsy proven NAFLD

Who cannot join

  • Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease
  • Liver Biopsy not done
  • Refused Consent

Trial locations and contacts

1 site in 1 country.

India1 site
  • Institute of liver and biliary sciences

    Delhi, 110070

Other trials in India

About this study

Official title: Effect of Indo-Mediterranean Diet on Hepatic Steatosis and Fibrosis in Overweight Children and Adolescent With Biopsy Proven NAFLD: A Randomised Control Trial

NAFLD encompasses the entire spectrum of Fatty liver disease in individuals without significant alcohol consumption, ranging from fatty liver to steatohepatitis to cirrhosis. A high prevalence of NAFLD (62.5%) was observed in overweight/obese Indian adolescent. Lifestyle modification consisting of diet, exercise and weight loss has been advocated to treat patients with NAFLD. European association for study of liver (EASL) guidelines recommends that the macronutrient in the diet should be adjusted according to the Mediterranean diet for weight loss. Mediterranean diet helps to decrease hepatic fat by decreasing lipogenesis, fibrogenesis, inflammation, oxidative stress and by increasing fatty acids beta oxidation.There are numerous studies in adults showing benefit of Mediterranean diet in comparison with other diet in NAFLD, but data on children is very limited. There are no studies in pediatrics showing the benefit of diet intervention in Indian NAFLD children. The aim of this study will be to compare the effect of Indo-Mediterranean diet and calorie restricted on hepatic steatosis and fibrosis in Overweight Indian children and adolescent with Biopsy proven NAFLD.

Read the detailed description

During the last decade, Nonalcoholic fatty liver disease (NAFLD) has become the most common cause of chronic hepatopathies in children and adolescents. NAFLD is considered as the hepatic manifestation of metabolic syndrome (MetS) and is defined as fat accumulation in the liver of patients who do not consume excessive amounts of alcohol. The mechanism of liver injury in NAFLD is considered to be a "Multiple hit process". The first "hit" leads to an increase in liver fat, while the next multiple factors lead to inflammation. In Developed countries, 4 to 11% of the general pediatric population is affected by NAFLD, reaching a rate of 70% among overweight and obese children. Lifestyle modification consisting of diet, exercise and weight loss has been proven to treat patients with NAFLD. Mediterranean diet (MD) has been largely evaluated for its beneficial effects in terms of prevention of obesity and MetS. Mediterranean diet is a nutritional model which has its origins in stated surrounding the Mediterranean Sea. MD patterns may vary among countries and regions owing to the cultural, ethnic, religious and agricultural differences. MD usually consists of eating primarily unrefined cereals, vegetables and fresh fruit, olive oil, nuts; eating fish, white meat, dairy products in moderation; limiting red meat, processed meats and sweets. MD helps to decrease hepatic fat by decreasing lipogenesis, fibrogenesis, inflammation, oxidative stress and by increasing fatty acids beta oxidation. MD is based on compounds, such as polyphenols, vitamins and other biomolecules that have anti inflammatory and antioxidant effects. It also has carotenoids and lycopenes which act as antioxidants. MD is characterized by high Mono unsaturated fatty acids content with a balanced Poly unsaturated fatty acids omega¬6 to omega¬3 ratio due to the abundance of vegetables, legumes, nuts, olive oil and fish (instead of red meats). There are numerous studies in adults showing benefit of Mediterranean diet in comparison with other diet in NAFLD, but data on children is very limited.

There are only two studies in children on the association between NAFLD and Mediterranean diet. Cakir et al first analysed in obese youth the association between MD adherance {as assessed by the Mediterranean diet quality index (KIDMED)} and NAFLD (as diagnosed by ultrasound and /or elevated ALT levels, as well exclusion of other causes of fatty liver). The authors evaluated overweight/obese children with (n=106) and without (n=21) NAFLD, as well as children (n=54) with normal BMI and without known chronic disease.Subjects with a low MD adherence were more likely to present with a higher BMI, though no correlation was found with other parameters including steatosis severity. Another study by Della Corte et al analysed the adherence to MD {as assessed by the Mediterranean diet quality index(KIDMED) score} in 243 overweight/obese youths with and without NAFLD. Of these, 100 underwent live biopsy. Poor adherance to MD was related to severity of liver damage as well as to higher levels of C-reactive Protein, Insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA IR) values, thus suggesting increased inflammatory potential of unhealthy diets. In the Indian scenario, it will be very difficult to follow Mediterranean diet, so a concept of Indo-Mediterranean was diet was introduced in a study by Singh et al. Total 499 patients were allocated to a Indo -Mediterranean diet rich in whole grains, fruits, vegetables, walnuts, and almonds. 501 controls consumed a local diet similar to the step I National Cholesterol Education Program (NCEP) prudent diet. It was seen that there was significant reduction in serum cholesterol concentration and other risk factors in both groups, but especially in the intervention diet (Indo -Mediterranean) group. Indo-Mediterranean diet was shown to reduce sudden cardiac death, Myocardial infarction, weight and BMI in Obese adults on follow up. In a study by Bharti et al, it was seen that Olive oil and Mustard oil are comparable and infact Mustard oil is suitable for Indian cooking settings, hence mustard oil can be used as instead of olive oil in Indo -Mediterranean diet. In summary, MD diet has been shown to be useful in NAFLD patients, also there is very limited data in pediatric literature about the advantages of MD in NAFLD children. The investigators aim compare the effect of Indo-Mediterranean diet and calorie restricted on hepatic steatosis and fibrosis in Overweight Indian children and adolescent with Biopsy proven NAFLD.

Being tested
Indo Mediterranean diet, Calorie restricted diet
Keywords
NAFLD, Indo-Mediterranean diet, Calorie restricted 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.

  • Indo Mediterranean dietOther

    Mediterranean diet has been shown to be effective in NAFLD adult patients. In India, it is very difficult to follow Mediterranean diet, so one group will be given Indianized version of mediterranean diet.

  • Calorie restricted dietOther

    One group will be given diet restricted in calories, which most of the patients follow to lose weight

Study groups in NCT05073588
Study groupRoleWhat they receive
Indo Mediterranean dietActive comparatorIndian version of Mediterranean diet will be given to NAFLD children
Receives: Other: Indo Mediterranean diet
Calorie restricted DietActive comparatorDiet restricted in calories will be given to NAFLD children
Receives: Other: Calorie restricted diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Primary outcome measure will be a composite end point defined by decrease in Controlled Attenuation Parameter (CAP) and Alanine Aminotransferase (ALT) values by 10% from baseline and decrease in Pediatric NAFLD Fibrosis Index score <3

    Decrease in CAP and ALT values by 10% from baseline and decrease in Pediatric NAFLD Fibrosis Index score <3

    Measured: 180 days

Secondary outcomes (2)
  1. Weight (Time frame : Change in Weight of atleast 7% from baseline at 180 days)

    Weight will be recorded at the baseline and at the completion of diet intervention

    Measured: 180 days

  2. Lipid Profile (Time frame : Change in Cholesterol, triglycerides of atleast 10% from baseline at 180 days)

    Lipid profile will be measured in a fasting state

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2021
  2. Study start16 Aug 2021
  3. Primary completion30 Mar 2023
  4. Study completion30 Mar 2023

Resources

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
Model description
Prospective, Randomized, Single centre Open label study
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05073588
Sponsor's protocol ID
ILBS-NAFLD-01
Status last verified
Sep 2022
First submitted
17 Sep 2021
Last updated
16 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Deshmukh A, Sood V, Lal BB, Khanna R, Alam S, Sarin SK. Effect of Indo-Mediterranean diet versus calorie-restricted diet in children with non-alcoholic fatty liver disease: A pilot randomized control trial. Pediatr Obes. 2024 Nov;19(11):e13163. doi: 10.1111/ijpo.13163. Epub 2024 Sep 2.

    PubMed 39223952

Questions about this trial

What is this clinical trial studying?

A study testing Indo Mediterranean diet and Calorie restricted diet in people with Non-Alcoholic Fatty Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.

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 4 inclusion and 3 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 16 Oct 2023. 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 India. 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?

The Primary outcome measure will be a composite end point defined by decrease in Controlled Attenuation Parameter (CAP) and Alanine Aminotransferase (ALT) values by 10% from baseline and decrease in Pediatric NAFLD Fibrosis Index score <3 (time frame: 180 days). 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 NCT05073588, 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 16 Oct 2023.

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