The Female Health Dietary Intervention Study (FEMIN)

The Hospital of Vestfold

Status: Completed

Conditions: Polycystic Ovary Syndrome; Morbid Obesity

Treatments: Behavioral: Crispbread

Study type: Interventional

Funder types: Other

Identifiers

NCT00779571

86-814d 6.2008.453

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: Female

Ages: 19 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Crispbread

Experimental group

Description:

Intervention: Crispbread LCD

Treatment:

Behavioral: Crispbread

Liquid meal replacement

Active Comparator group

Description:

Intervention: LMR LCD

Treatment:

Behavioral: Crispbread