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CompletedNCT05073588Updated Oct 16, 2023

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

An interventional study of Indo Mediterranean diet and Calorie restricted diet in Non-Alcoholic Fatty Liver Disease, sponsored by Institute of Liver and Biliary Sciences, India. Completed at 1 site in India. Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-16.

Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
8 Years to 18 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Non-Alcoholic Fatty Liver Disease

Keywords

  • NAFLD
  • Indo-Mediterranean diet
  • Calorie restricted diet
03

In context

Non-alcoholic Fatty Liver Disease

1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's enrollment of 39 is below the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease
  • Liver Biopsy not done
  • Refused Consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Active comparator
    Indo Mediterranean diet

    Indian version of Mediterranean diet will be given to NAFLD children

    Other: Indo Mediterranean diet

  • Active comparator
    Calorie restricted Diet

    Diet restricted in calories will be given to NAFLD children

    Other: Calorie restricted diet

Interventions

  • OtherIndo Mediterranean diet

    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.

  • OtherCalorie restricted diet

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

06

What researchers measure

Primary outcomes

  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

    Time frame: 180 days

Secondary outcomes

  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

    Time frame: 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

    Time frame: 180 days

07

Study locations

1 site
  • Institute of liver and biliary sciences
    Delhi, 110070, India
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2021 to primary completion in Mar 2023, 19 months.

Of 323 non-industry interventional studies with no phase under Non-alcoholic Fatty Liver Disease, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 19 months is below that.

Counting every sponsor, half of 350 studies reached it within 24 months; a quarter within 12 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2021
First posted
Oct 11, 2021
StartActual
Aug 16, 2021
Primary completionActual
Mar 30, 2023
CompletionActual
Mar 30, 2023
Last update
Oct 16, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05073588
Responsible party
Sponsor
First posted
Oct 11, 2021
Start date
Aug 16, 2021
Primary completion
Mar 30, 2023
Completion
Mar 30, 2023
Last update
Oct 16, 2023

Study contacts

Aniket Deshmukh, DM
principal investigator · Institute of Liver and Biliary Sciences, India

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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