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Studying the Effect of Mediterranean Diet on Insulin Resistance Among Obese Children and Adolescents

Primary Purpose

Obesity, Childhood, Insulin Resistance

Status
Unknown status
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood focused on measuring Mediterranean Diet

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Jordan

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

regular diet

Mediterranean diet

Arm Description

50% of energy from carbohydrates, 30% fat and 20% from protein

60% of energy from carbohydrates, 25% fat and 15% from protein

Outcomes

Primary Outcome Measures

Mediterranean Diet and insulin Resistance
Mediterranean Diet change of blood level of Homa IR among Obese Children and Adolescents
Mediterranean Diet and body weight
Mediterranean Diet change in body weight in kilogram among Obese Children and Adolescents

Secondary Outcome Measures

Mediterranean Diet and lipid profile
Mediterranean Diet change of blood level of lipid profile among Obese Children and Adolescents

Full Information

First Posted
February 24, 2020
Last Updated
March 16, 2020
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT04313452
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
February 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Insulin Resistance
Keywords
Mediterranean Diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
regular diet
Arm Type
Placebo Comparator
Arm Description
50% of energy from carbohydrates, 30% fat and 20% from protein
Arm Title
Mediterranean diet
Arm Type
Active Comparator
Arm Description
60% of energy from carbohydrates, 25% fat and 15% from protein
Intervention Type
Other
Intervention Name(s)
the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged
Other Intervention Name(s)
Diet intervention
Intervention Description
to find the effect of Mediterranean diet on insulin resistance among obese children and adolescents aged 10-16 years with insulin resistance compared to the regular diet
Primary Outcome Measure Information:
Title
Mediterranean Diet and insulin Resistance
Description
Mediterranean Diet change of blood level of Homa IR among Obese Children and Adolescents
Time Frame
6 month
Title
Mediterranean Diet and body weight
Description
Mediterranean Diet change in body weight in kilogram among Obese Children and Adolescents
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Mediterranean Diet and lipid profile
Description
Mediterranean Diet change of blood level of lipid profile among Obese Children and Adolescents
Time Frame
6 month

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reema F Tayyam, PHD
Organizational Affiliation
University of Jordan
Official's Role
Study Director
Facility Information:
Facility Name
University of Jordan
City
Amman
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan 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. The study will be started after getting the Institutional Review Boards (IRB) approval.
IPD Sharing Time Frame
Patients will be followed-up every 2 weeks in the clinic for 6 months
IPD Sharing Access Criteria
Obese children and adolescents, BMI for age and sex is greater than the +2rd z-score, according to WHO growth chart, age between 10-16 years. Children and adolescents diagnosed with insulin resistance and presence of acanthosis nigricans and not on medication.
Citations:
PubMed Identifier
14715836
Citation
Cruz ML, Weigensberg MJ, Huang TT, Ball G, Shaibi GQ, Goran MI. The metabolic syndrome in overweight Hispanic youth and the role of insulin sensitivity. J Clin Endocrinol Metab. 2004 Jan;89(1):108-13. doi: 10.1210/jc.2003-031188.
Results Reference
background
PubMed Identifier
28726334
Citation
Arslanian S, Kim JY, Nasr A, Bacha F, Tfayli H, Lee S, Toledo FGS. Insulin sensitivity across the lifespan from obese adolescents to obese adults with impaired glucose tolerance: Who is worse off? Pediatr Diabetes. 2018 Mar;19(2):205-211. doi: 10.1111/pedi.12562. Epub 2017 Jul 20.
Results Reference
result
PubMed Identifier
16572718
Citation
Bener A. Prevalence of obesity, overweight, and underweight in Qatari adolescents. Food Nutr Bull. 2006 Mar;27(1):39-45. doi: 10.1177/156482650602700106.
Results Reference
result
PubMed Identifier
19692213
Citation
Bos MB, de Vries JH, Feskens EJ, van Dijk SJ, Hoelen DW, Siebelink E, Heijligenberg R, de Groot LC. Effect of a high monounsaturated fatty acids diet and a Mediterranean diet on serum lipids and insulin sensitivity in adults with mild abdominal obesity. Nutr Metab Cardiovasc Dis. 2010 Oct;20(8):591-8. doi: 10.1016/j.numecd.2009.05.008. Epub 2009 Aug 18.
Results Reference
result
PubMed Identifier
26556369
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.
Results Reference
result

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Studying the Effect of Mediterranean Diet on Insulin Resistance Among Obese Children and Adolescents

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