The Female Health Dietary Intervention Study

Polycystic Ovary Syndrome Clinical Trial

— FEMIN  

Official title:

Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779571
• Other study ID #: 86-814d 6.2008.453
• Status: Completed
• Phase: N/A
• First received: October 22, 2008
• Last updated: October 9, 2014
• Start date: October 2008
• Est. completion date: February 2012

Study information

• Verified date: October 2014
• Source: The Hospital of Vestfold
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

This study has two phases:

1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared.

2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.

Description:

Weight loss is an important and effective treatment of morbidly obese women with PCOS. Effective weight reduction will improve manifestations of PCOS and risk factors for developing type 2 diabetes and coronary heart diseases. We compare the effect of two isocaloric low calorie diets (LCD), - one powder-based shake-diet and a fiber rich diet on the above mentioned parameters. In addition we want to compare the weight-maintenance effect the next 44 weeks of two different follow-up programs: A usual care- and a lifestyle-program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 38 Years

Eligibility

Inclusion Criteria:

• Woman (European Caucasian)

• PCOS

• BMI = or > 35

Exclusion Criteria:

• Cushing syndrome

• Adrenal hyperplasia

• Androgen-producing tumors

• Anovulation caused by hyperprolactinemia

• Pregnancy, breast feeding

• Use of oral contraceptives/hormone treatment/insulin-sensitizing agents

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Polycystic Ovary Syndrome

Intervention

Behavioral:
• Crispbread
8 week low calorie diet

Locations

Country	Name	City	State
Norway	Kvinneklinikken, Rikshospitalet-Radiumhospitalet HF	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital of Vestfold	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		One year	No
Secondary	Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors		one year	No