Effects of high protein intake in obese childre

Completed

• Conditions: obesitas en daaraan gerelateerde aandoeningen; obesity; overweight; 10018424

• Registration Number: NL-OMON39425
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- obesity (BMI-SDS > 2.0)
- age 8-12 years
- pre-pubertal (Tanner stage 1)
- child and parents/caretakers are highly motivated to participate in the study
- written informed consent of the parents/caretakers

Exclusion Criteria

- obesity that is caused by a somatic treatable disorder
- use of systemic steroids

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in body composition (body fat%, fat-free mass, fat mass, fat-free<br /><br>mass index, fat mass index , waist and hip circumference, waist:hip ratio) in<br /><br>obese children who consumed a high protein diet for 4 weeks. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Whole body protein turnover, gluconeogenesis, energy expenditure, insulin<br /><br>sensitivity, cortisol concentration in hair, and markers of dyslipidemia and<br /><br>oxidative stress . The endpoints whole body protein turnover, gluconeogenesis,<br /><br>synthesis rate of apolipoprotein B100 and the synthesis rate of glutathione<br /><br>will be measured in a subgroup of the children, as there will be no more<br /><br>intravenous infusion of stable isotopes from March 2014 onwards.</p><br>