Obesity, ChildhoodNCT04313452
Studying the Effect of Mediterranean Diet on Insulin Resistance Among Obese Children and Adolescents
A study testing the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged in people with Obesity, Childhood and Insulin Resistance, run by University of Jordan at 1 site in Jordan.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Insulin Resistance
- What is being tested?
- the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- 27 Feb 2020to 1 Feb 2021
- 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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).
- Conditions
- Obesity, Childhood, Insulin Resistance
- Being tested
- the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged
- Keywords
- Mediterranean Diet
- Medical subject headings
- Pediatric Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents agedOther
Also called Diet intervention
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
| Study group | Role | What they receive |
|---|---|---|
| regular diet | Placebo comparator | 50% of energy from carbohydrates, 30% fat and 20% from protein Receives: Other: the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged |
| Mediterranean diet | Active comparator | 60% of energy from carbohydrates, 25% fat and 15% from protein Receives: Other: the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mediterranean Diet and insulin Resistance
Mediterranean Diet change of blood level of Homa IR among Obese Children and Adolescents
Measured: 6 month
Mediterranean Diet and body weight
Mediterranean Diet change in body weight in kilogram among Obese Children and Adolescents
Measured: 6 month
Secondary outcomes (1)
Mediterranean Diet and lipid profile
Mediterranean Diet change of blood level of lipid profile among Obese Children and Adolescents
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start27 Feb 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Farrah, University of Jordan
- Investigators
- Reema F Tayyam, PHD, Study director, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313452
- Sponsor's protocol ID
- 8170598
- Status last verified
- Mar 2020
- First submitted
- 24 Feb 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: -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.
Publications
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.
PubMed 14715836Arslanian 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.
PubMed 28726334Bener A. Prevalence of obesity, overweight, and underweight in Qatari adolescents. Food Nutr Bull. 2006 Mar;27(1):39-45. doi: 10.1177/156482650602700106.
PubMed 16572718Bos 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.
PubMed 19692213Davis 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.
PubMed 26556369
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04313452
- Acronym / sponsor ID
- 8170598
- Conditions
- Obesity, Childhood, Insulin Resistance
- Keywords
- Mediterranean Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 18 Mar 2020 (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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| regular diet | Placebo comparator | Other: the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged50% of energy from carbohydrates, 30% fat and 20% from protein |
| Mediterranean diet | Active comparator | Other: the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged60% of energy from carbohydrates, 25% fat and 15% from protein |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents agedAlso: Diet interventionto 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 | Other | Mediterranean diet, regular diet |
Primary outcome
Mediterranean Diet and insulin Resistance
Time frame: 6 month
Mediterranean Diet change of blood level of Homa IR among Obese Children and Adolescents
Mediterranean Diet and body weight
Time frame: 6 month
Mediterranean Diet change in body weight in kilogram among Obese Children and Adolescents
1 secondary outcome
Mediterranean Diet and lipid profile
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 14715836Cruz 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 publication: PubMed 28726334Arslanian 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 publication: PubMed 16572718Bener A. Prevalence of obesity, overweight, and underweight in Qatari adolescents. Food Nutr Bull. 2006 Mar;27(1):39-45. doi: 10.1177/156482650602700106.
- Results publication: PubMed 19692213Bos 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 publication: PubMed 26556369Davis 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.
- Individual participant dataSharing planned: Yes. -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.
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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.
Reema F Tayyam, PHD study director
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged in people with Obesity, Childhood and Insulin Resistance, run by University of Jordan at 1 site in Jordan.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Mar 2020. 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 Jordan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Mediterranean Diet and insulin Resistance (time frame: 6 month). The study lists 2 primary outcomes in all. 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 NCT04313452, which also lists 5 linked publications.
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 18 Mar 2020.