The Female Health Dietary Intervention Study

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome; Morbid Obesity
• Interventions: Behavioral: Crispbread

• Registration Number: NCT00779571
• Lead Sponsor: The Hospital of Vestfold

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-24
• Primary Completion: 2011-09
• Study Completion: 2012-02
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-09
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crispbread	Crispbread	Intervention: Crispbread LCD
Liquid meal replacement	Crispbread	Intervention: LMR LCD

Primary Outcome Measures

Name	Time	Method
Weight loss	One year

Secondary Outcome Measures

Name	Time	Method
Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors	one year

Trial Locations

Locations (1)

Kvinneklinikken, Rikshospitalet-Radiumhospitalet HF; 🇳🇴 Oslo, Norway