NCT01763528

Brief Summary

The investigators aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
Last Updated

January 9, 2013

Status Verified

January 1, 2013

Enrollment Period

1.5 years

First QC Date

December 18, 2012

Last Update Submit

January 8, 2013

Conditions

Body Mass Index Quantitative Trait Locus 8 DisorderTangier Disease

Keywords

body weightLow-density-lipoprotein-type

Outcome Measures

Primary Outcomes (1)

  • the amount of weight reduction in two dietary groups

    weight reduction (kg)

    3 months

Secondary Outcomes (6)

  • LDL-C (mg/dl

    3 months

  • HDL-C (mg/dl)

    3 months

  • total cholesterol (mg/dl)

    3 months

  • fasting blood glucose(mg/dl)

    3 months

  • blood pressure (mmHg)

    3 months

  • +1 more secondary outcomes

Study Arms (2)

nutrition intervention

ACTIVE COMPARATOR

high protein diet

Other: nutrition intervention

control group

NO INTERVENTION

control diet

Interventions

nutrition interventionOTHER

high protein diet

nutrition intervention

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women aged between 20-65 years
  • BMI \> 25 kg/m2
  • were no smoker
  • no history of renal, liver, metabolic diseases or type 1 or 2 diabetes

You may not qualify if:

  • had gastrointestinal, respiratory, cardiovascular, metabolic, liver and renal -diseases
  • had macroalbuminuria
  • were pregnancy or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Azadbakht L, Izadi V, Surkan PJ, Esmaillzadeh A. Effect of a High Protein Weight Loss Diet on Weight, High-Sensitivity C-Reactive Protein, and Cardiovascular Risk among Overweight and Obese Women: A Parallel Clinical Trial. Int J Endocrinol. 2013;2013:971724. doi: 10.1155/2013/971724. Epub 2013 Aug 6.

    PMID: 23986778DERIVED

MeSH Terms

Conditions

Tangier DiseaseBody Weight

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 DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Leila Azadbakht, PhD

    Isfan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

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

December 18, 2012

First Posted

January 9, 2013

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

January 9, 2013

Record last verified: 2013-01