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.
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.
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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- 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 group | Role | What they receive |
|---|---|---|
| Indo Mediterranean diet | Active comparator | Indian version of Mediterranean diet will be given to NAFLD children Receives: Other: Indo Mediterranean diet |
| Calorie restricted Diet | Active comparator | Diet 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.
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)
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
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.
- First posted11 Oct 2021
- Study start16 Aug 2021
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
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 Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Model description
- Prospective, Randomized, Single centre Open label study
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aniket Deshmukh, DM, Principal investigator, Institute of Liver and Biliary Sciences, India
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05073588
- Acronym / sponsor ID
- ILBS-NAFLD-01
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- NAFLD, Indo-Mediterranean diet, Calorie restricted diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 11 Oct 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Randomized, Single centre Open label study
| Arm | Type | Receives |
|---|---|---|
| Indo Mediterranean diet | Active comparator | Other: Indo Mediterranean dietIndian version of Mediterranean diet will be given to NAFLD children |
| Calorie restricted Diet | Active comparator | Other: Calorie restricted dietDiet restricted in calories will be given to NAFLD children |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 8-18 years
- BMI > 85th centile
- Ultrasonography abdomen s/o Fatty Liver
- Biopsy proven NAFLD
Key exclusion criteria (3 listed)
- Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease
- Liver Biopsy not done
- Refused Consent
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 |
|---|---|---|
| Indo Mediterranean dietMediterranean 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. | Other | Indo Mediterranean diet |
| Calorie restricted dietOne group will be given diet restricted in calories, which most of the patients follow to lose weight | Other | Calorie restricted Diet |
Primary outcome
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
Decrease in CAP and ALT values by 10% from baseline and decrease in Pediatric NAFLD Fibrosis Index score <3
2 secondary outcomes
Weight (Time frame : Change in Weight of atleast 7% from baseline at 180 days)
Time frame: 180 days
Lipid Profile (Time frame : Change in Cholesterol, triglycerides of atleast 10% from baseline at 180 days)
Time frame: 180 days
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 16 Oct 2023.
- Derived from this study: PubMed 39223952Deshmukh 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.
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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.
Aniket Deshmukh, DM principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
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.