Clinical trial NCT04313452: Studying the Effect of Mediterranean Diet on Insulin Resistance Among Obese Children and Adolescents
Official title: Studying the Effect of Mediterranean Diet on Insulin Resistance Compared to the Regular Diet Among Obese Children and Adolescents Aged 10-16 Years.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Childhood
Insulin Resistance
Keywords: Mediterranean Diet
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study sample will consist of 50 participants of obese children and adolescents between 10 and 16 years of age who are diagnosed with insulin resistance clinically. Twenty five of participants (1:1, boys: girls) will follow Mediterranean diet, and 25 of participants (1:1, boys: girls) will follow regular diet. The two groups will be matched for age and gender. The Pediatric Endocrinologist will diagnose the children with insulin resistance clinically according to abdominal obesity and presence of acanthosis nigricans. The children and adolescents will be randomly assigned to one of the groups: Mediterranean diet group or the regular diet group.
Primary purpose: PREVENTION

Brief summary: Insulin resistance is a common complication of childhood obesity. It is considered to be an important link between adiposity and the risk factor of type 2 diabetes in children. The lifestyle modifications, including a healthy diet, physical activity and weight reduction in obese children and adolescents have been proven effective in type 2 diabetes prevention and management. Although increasing evidence suggests that Mediterranean diet could be associated with decreased risk of metabolic syndrome, diabetes, obesity and atherosclerosis in adults.

The importance of this study is to find the effect of Mediterranean diet on insulin resistance among obese children and adolescents aged 10-16 years. Additionally, the results of the present study will help health professionals particularly dietitians in directing children with insulin resistance towards adopting healthy diet and lifestyle.

Detailed description: This Experimental clinical trial study will be conducted in Amman, the capital of Jordan to compare the effect of Mediterranean diet and regular diet on insulin resistance among 50 participants of obese children and adolescents (between 10 and 16 years of age) who are diagnosed with insulin resistance clinically, Twenty five of participants (1:1, boys: girls) will follow Mediterranean diet, and 25 of participants (1:1, boys: girls) will follow regular diet. The two groups will be matched for age and gender. The Pediatric Endocrinologist will diagnose the children with insulin resistance clinically according to abdominal obesity and presence of acanthosis nigricans. The children and adolescents will be randomly assigned to one of the groups: Mediterranean diet group or the regular diet group. Patients are visiting the Pediatric Diabetes and Endocrinology department in Jordan University Hospital. will be followed-up every 2 weeks in the clinic for 6 months.

The researcher will measure body weight , height, and calculate BMI for all patients every visit. Then will be represented and interpreted using the suitable growth chart (weight for age, height for age, BMI for age and gender).

Glycated hemoglobin (HbA1c), serum concentrations of total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, (after a 12 hour fast), aspartate aminotransferase (AST), and alanine aminotransferase (ALT), Kidney function, thyroid hormone will be recorded from the medical file of the patients.

Insulin resistance will be assessed by the homeostatic model assessment (HOMA-IR), calculated as the product of the fasting plasma insulin level (IU/l) and the fasting plasma glucose level (mmol/l) divided by 22.5. The fasting plasma insulin level (FPI) and the fasting plasma glucose level (FPG) will be measured after at least an 8-hour fasting at baseline after 3 months, and at the end of the intervention.

The intervention programs will be based on the implementation of Mediterranean diet and regular diet. Participants will be counseled and educated about the two diet programs. The two groups will be:

Group 1: regular diet ( 50% of energy from carbohydrates, 30% fat and 20% from protein) Group 2: Mediterranean diet ( 60% of energy from carbohydrates, 25% fat and 15% from protein).

Eligibility criteria: Inclusion Criteria:

* Age range between 10-16 years.
* Obese children and adolescents, BMI for age and sex is greater than the +2rd z-score, according to WHO growth chart.
* Children and adolescents diagnosed with insulin resistance and presence of acanthosis nigricans.
* Not on medication.

Exclusion Criteria:

* Age younger than 10 years or older than 16 years.
* Overweight children and adolescents or obese (BMI for age and sex is less than +2rd z-score, according to WHO growth chart.
* Children and adolescents didn't diagnosis of insulin resistance
* On any medication.

Primary outcomes:
measure: Mediterranean Diet and insulin Resistance
timeFrame: 6 month
measure: Mediterranean Diet and body weight
timeFrame: 6 month
Secondary outcomes:
measure: Mediterranean Diet and lipid profile
timeFrame: 6 month
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan
Study officials:
affiliation: University of Jordan
name: Reema F Tayyam, PHD
role: STUDY_DIRECTOR
References:
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citation: Davis C, Bryan J, Hodgson J, Murphy K. Definition of the Mediterranean Diet; a Literature Review. Nutrients. 2015 Nov 5;7(11):9139-53. doi: 10.3390/nu7115459.