High Protein Weight Loss Diet, High Sensitivity C-Reactiv... | NCT01763528

Studies
High Protein Weight Loss Diet, High Sensitivity C-Reactive Protein and Cardiovascular Risks Among Obese Women

NCT01763528

Sponsor

Isfahan University of Medical Sciences

Status

Completed

Last Update Posted

Jan 9, 2013Estimated

Enrollment

63Actual

Phase

Phase 3

Conditions

Body Mass Index Quantitative Trait Locus 8 Disorder
Tangier Disease

Interventions

nutrition intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Dec 18, 2012

First Submission Date that Met QC Criteria

Jan 8, 2013

First Posted Date

Jan 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2013

Last Update Posted Date

Jan 9, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leila Azadbakht, Isfahan University of Medical Sciences,, Isfahan University of Medical SciencesPrincipal Investigator

Lead Sponsor

Isfahan University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design: In this randomized controlled trial, we recruited 60 overweight and obese women, aged 20-65 years into HP or control energy restricted diets for three months (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, hs-CRP, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nutrition intervention	Active Comparator	high protein diet	Other: nutrition intervention
control group	No Intervention	control diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nutrition intervention	Other	high protein diet	nutrition intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the amount of weight reduction in two dietary groups	weight reduction (kg)	3 months

Secondary Outcomes

Measure	Description	Time Frame
LDL-C (mg/dl	measurement of LDL-C (mg/dl), HDL-C (mg/dl), total cholesterol (mg/dl), fasting blood glucose (mg/dl), systolic and diastolic blood pressure (mmHg), c reactive protein by the measurement of blood samples.	3 months
HDL-C (mg/dl)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leila Azadbakht, PhD	Isfan University of Medical Sciences	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23986778	Derived	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.

ID	Term
D013631	Tangier Disease
D001835	Body Weight

ID	Term
D011115	Polyneuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

ID	Term
D044623	Nutrition Therapy
D013812	Therapeutics