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Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01886482
Enrollment
50
Registered
2013-06-26
Start date
2011-09-30
Completion date
2012-09-30
Last updated
2013-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Mass Index Quantitative Trait Locus 7 Disorder, Tangier Disease

Brief summary

The investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.

Detailed description

Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD) risk factors have reported contradictory results. Objective: In present study, the investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children. Design: In this randomized controlled trial, the investigators recruited 50 overweight and obese women, aged 6-11years into HP or control energy restricted diets for 10 weeks (protein, carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount, divided to animal and plant sources in 50%-50% and animal sources distributed (half/half) between meats and dairy products. Fasting blood samples, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.

Interventions

OTHERnutrition intervention

high protein diet

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI \> 85th age of 6-11 years * no history of chronic diseases * no taken medications

Exclusion criteria

* do not prescribe their diet * mental retardation

Design outcomes

Primary

MeasureTime frameDescription
the amount of weight reduction in two dietary groups10 weeksweight reduction (kg)

Secondary

MeasureTime frame
LDL (mg/ml)10 weeks
HDL (mg/ml)10 weeks
fasting blood glucose10 weeks
total cholesterol (mg/dl)10 weeks
blood pressure10 weeks

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026