Skip to main content
OpenTrials
Completed

NCT Number: NCT00779571

The Female Health Dietary Intervention Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Body Weight Cardiovascular Diseases Coronary Disease Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Heart Diseases Morbid Obesity Myocardial Ischemia Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Vascular Diseases

Age range

19 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kvinneklinikken, Rikshospitalet-Radiumhospitalet HF

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crispbread

Behavioral

8 week low calorie diet

Primary outcomes

  1. Weight loss

    Time frame: One year

Secondary outcomes

  1. Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors

    Time frame: one year

Sponsors and collaborators

Lead sponsor

The Hospital of Vestfold

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

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

Acronym: FEMIN

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Oct 24, 2008
Registry last updated
Oct 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.