Clinical trial · Interventional
The Female Health Dietary Intervention Study
Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study
NCT00779571CI-TRIAL-00015825FEMINcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Morbid Obesity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Crispbread | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Crispbread
- description
- Intervention: Crispbread LCD
- interventionNames
- Behavioral: Crispbread
- type
- ACTIVE_COMPARATOR
- label
- Liquid meal replacement
- description
- Intervention: LMR LCD
- interventionNames
- Behavioral: Crispbread
Primary outcomes (1)
- measure
- Weight loss
- timeFrame
- One year
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 38 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJohnson LK, Holven KB, Nordstrand N, Mellembakken JR, Tanbo T, Hjelmesaeth J. Fructose content of low calorie diets: effect on cardiometabolic risk factors in obese women with polycystic ovarian syndrome: a randomized controlled trial. Endocr Connect. 2015 Sep;4(3):144-54. doi: 10.1530/EC-15-0047. PMID 26138702