NCT01886482

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2013

Enrollment Period

3 months

First QC Date

June 21, 2013

Last Update Submit

June 25, 2013

Conditions

Body Mass Index Quantitative Trait Locus 7 DisorderTangier Disease

Outcome Measures

Primary Outcomes (1)

  • the amount of weight reduction in two dietary groups

    weight reduction (kg)

    10 weeks

Secondary Outcomes (5)

  • LDL (mg/ml)

    10 weeks

  • HDL (mg/ml)

    10 weeks

  • fasting blood glucose

    10 weeks

  • total cholesterol (mg/dl)

    10 weeks

  • blood pressure

    10 weeks

Study Arms (2)

nutrition intervention

ACTIVE COMPARATOR

high protein diet

Other: nutrition intervention

no intervention

NO INTERVENTION

control diet

Interventions

nutrition interventionOTHER

high protein diet

nutrition intervention

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • do not prescribe their diet
  • mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, Iran

Location

MeSH Terms

Conditions

Tangier Disease

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

PolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesHypoalphalipoproteinemiasHypolipoproteinemiasLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Isfahan University of Medical Sciences

Study Record Dates

First Submitted

June 21, 2013

First Posted

June 26, 2013

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

September 1, 2012

Last Updated

June 26, 2013

Record last verified: 2013-06

Locations

IR(1)