Studying the Effect of Mediterranean Diet on Insulin Resistance Among Obese Children and Adolescents
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Insulin Resistance
- Obesity, Childhood
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Single (Investigator)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 10 years and 16 years
- Gender
- Both males and females
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 resistan...
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).
Tracking Information
- NCT #
- NCT04313452
- Collaborators
- Not Provided
- Investigators
- Study Director: Reema F Tayyam, PHD University of Jordan