Polycystic Ovary SyndromeNCT01184963
High Versus Normal Protein Diet in Polycystic Ovary Syndrome (PCOS)
A study testing High protein diet and Normal protein diet in people with Polycystic Ovary Syndrome, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- High protein diet and Normal protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- women of reproductive age
- BMI ranging from 18.5 to 39.9 kg/m²
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: Effect of High-protein or Normal-protein Diet on Weight Loss, Body Composition, Hormone and Metabolic Profile in Women With Polycystic Ovary Syndrome From South Brazil: A Randomized Study
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- High protein diet, Normal protein diet
- Keywords
- PCOS, High protein diet
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein dietDietary supplement
High protein diet (30% protein, 40% carbohydrate, 30% lipid)
Normal protein dietDietary supplement
Normal protein diet (15% protein, 55% carbohydrate, 30% lipid
| Study group | Role | What they receive |
|---|---|---|
| Controls | Other | Women in reproductive age regular ovulatory cycles Receives: Dietary Supplement: High protein diet; Dietary Supplement: Normal protein diet |
| PCOS patients | Other | Patients with anovulatory cycles, hyperandrogenism with or without polycystic ovarian appearance Receives: Dietary Supplement: High protein diet; Dietary Supplement: Normal protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in corporal weight
Measured: 8 weeks
Secondary outcomes (2)
Changes in body composition
Measured: 8 weeks
changes in hormone and metabolic profile.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Poli Mara Spritzer, PhD, MD, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184963
- Sponsor's protocol ID
- 04-364
- Status last verified
- Dec 2009
- First submitted
- 17 Aug 2010
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-protein or Normal-protein Diet on Weight Loss, Body Composition, Hormone and Metabolic Profile in Women With Polycystic Ovary Syndrome From South Brazil: A Randomized Study
- ClinicalTrials.gov ID
- NCT01184963
- Acronym / sponsor ID
- 04-364
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, High protein diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | Other | Dietary Supplement: High protein diet, Dietary Supplement: Normal protein dietWomen in reproductive age regular ovulatory cycles |
| PCOS patients | Other | Dietary Supplement: High protein diet, Dietary Supplement: Normal protein dietPatients with anovulatory cycles, hyperandrogenism with or without polycystic ovarian appearance |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- women of reproductive age
- BMI ranging from 18.5 to 39.9 kg/m²
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High protein dietHigh protein diet (30% protein, 40% carbohydrate, 30% lipid) | Dietary supplement | Controls, PCOS patients |
| Normal protein dietNormal protein diet (15% protein, 55% carbohydrate, 30% lipid | Dietary supplement | Controls, PCOS patients |
Primary outcome
Changes in corporal weight
Time frame: 8 weeks
2 secondary outcomes
Changes in body composition
Time frame: 8 weeks
changes in hormone and metabolic profile.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2010.
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poli Mara Spritzer, PhD, MD study director
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein diet and Normal protein diet in people with Polycystic Ovary Syndrome, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in corporal weight (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2010.