High Versus Normal Protein Diet in Polycystic Ovary Syndr... | NCT01184963

Studies
High Versus Normal Protein Diet in Polycystic Ovary Syndrome (PCOS)

NCT01184963

Sponsor

Federal University of Rio Grande do Sul

Status

Completed

Last Update Posted

Aug 19, 2010Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Polycystic Ovary Syndrome

Interventions

High protein diet
Normal protein diet

Countries

Brazil

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

Dec 2009

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

Mar 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Aug 17, 2010

First Submission Date that Met QC Criteria

Aug 18, 2010

First Posted Date

Aug 19, 2010Estimated

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

Aug 18, 2010

Last Update Posted Date

Aug 19, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Federal University of Rio Grande do SulOTHER

Collaborators

Name	Class
Hospital de Clinicas de Porto Alegre	OTHER
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.	OTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

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 objective of this study is to assess the effects of a high protein (HP) and a normal protein diet (NP) on patients with polycystic ovary syndrome (PCOS) and body mass index (BMI)-matched controls in a sample of southern Brazilian women.

Patients will be randomized to receive high protein (30% protein, 40% carbohydrate, 30% lipid) or normal protein (15% protein, 55% carbohydrate, 30% lipid) during eight weeks.

The investigators hypothesis is that a different diet composition may have influences in changes of the main characteristics of PCOS, like hyperandrogenism and metabolic syndrome.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Controls	Other	Women in reproductive age regular ovulatory cycles	Dietary Supplement: High protein diet Dietary Supplement: Normal protein diet
PCOS patients	Other	Patients with anovulatory cycles, hyperandrogenism with or without polycystic ovarian appearance	Dietary Supplement: High protein diet Dietary Supplement: Normal protein diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High protein diet	Dietary Supplement	High protein diet (30% protein, 40% carbohydrate, 30% lipid)	Controls PCOS patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in corporal weight		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in body composition		8 weeks
changes in hormone and metabolic profile.		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women of reproductive age
BMI ranging from 18.5 to 39.9 kg/m²

Exclusion Criteria:

Use of any drugs known to interfere with hormone levels for at least 3 months before the study
Women with known type 2 diabetes, liver or renal disease or thyroid dysfunction
Other hyperandrogenic disorders than PCOS

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

35 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Poli Mara Spritzer, PhD, MD	Federal University of Rio Grande do Sul	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clínicas de Porto Alegre		Porto Alegre	Rio Grande do Sul	90035-003	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000073600	Diet, High-Protein

Ancestor Terms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747

Browse Leaves

Not provided

Browse Branches

Not provided