Trial record 6 of 11 for:
"familial HDL deficiency" OR "Hypoalphalipoproteinemias"
Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children
This study has been completed.
Sponsor:
Isfahan University of Medical Sciences
Information provided by (Responsible Party):
Leila Azadbakht, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01886482
First received: June 21, 2013
Last updated: June 25, 2013
Last verified: June 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.
| Condition | Intervention | Phase |
|---|---|---|
|
Body Mass Index Quantitative Trait Locus 7 Disorder Tangier Disease |
Other: nutrition intervention |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
Tangier disease
cholesteryl ester storage disease
familial HDL deficiency
U.S. FDA Resources
Further study details as provided by Isfahan University of Medical Sciences:
Primary Outcome Measures:
- the amount of weight reduction in two dietary groups [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]weight reduction (kg)
Secondary Outcome Measures:
- LDL (mg/ml) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
- HDL (mg/ml) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
- fasting blood glucose [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
- total cholesterol (mg/dl) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
- blood pressure [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 50 |
| Study Start Date: | September 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: nutrition intervention
high protein diet
|
Other: nutrition intervention
high protein diet
|
|
No Intervention: no intervention
control diet
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 11 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886482
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886482
Locations
| Iran, Islamic Republic of | |
| Isfahan University of Medical Sciences | |
| Isfahan, Iran, Islamic Republic of | |
Sponsors and Collaborators
Isfahan University of Medical Sciences
More Information
| Responsible Party: | Leila Azadbakht, Isfahan University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01886482 History of Changes |
| Other Study ID Numbers: | high protein diet in childhood |
| Study First Received: | June 21, 2013 |
| Last Updated: | June 25, 2013 |
| Health Authority: | Iran: Ethics Committee |
Additional relevant MeSH terms:
|
Hypoalphalipoproteinemias Tangier Disease Polyneuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Hypolipoproteinemias |
Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on September 28, 2016