A trial to compare the effect of weight loss diets on obese women with polycystic ovarian syndrome (PCOS)

Not Applicable

Completed

• Conditions: PCOS and obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN36687466
• Lead Sponsor: Hull and East Yorkshire Hospitals

Brief Summary

2021 Abstract results in https://doi.org/10.1530/endoabs.77.P107 (added 18/02/2022) 2023 Results article in https://doi.org/10.3390/nu15183872 (added 10/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-24
• Study Completion: 2018-05-01
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

1. Women, aged 18-45 years (inclusive)
2. Individuals wishing to lose weight
3. Body Mass Index (BMI)=30 kg/m2 and <45 kg/m2
4. Have a reliable form of contraception in place
5. Confirmed diagnosis of PCOS based on Rotterdam criteria
6. Willing to commit to 18 weeks of no alcohol and significant alterations to their social life e.g. eating out, holidays, and celebrations

Exclusion Criteria

1. Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing’s disease and androgen-secreting tumours will be excluded by appropriate tests
2. Any concurrent illness including type 2 diabetes
3. Subjects who are on any of the following medications within 3 months of recruitment
4. Metformin or other insulin-sensitizing medications (e.g., pioglitazone). If cessation of the drug is agreed between the medics and the patient, in preparation for the trial an 8 week washout is required.
5. Hormonal contraceptives (e.g., birth control pills, hormone-releasing implants, etc.). Subjects will be advised to use barrier contraception during the study period. If cessation of the drug is agreed between the medics and the patient, in preparation for the trial a 4 week washout is required.
6. Anti-androgens (e.g., spironolactone, flutamide, finasteride, etc.). If cessation of the drug is agreed between the medics and the patient, in preparation for the trial a 8 week washout is required.
7. Clomiphene citrate or estrogen modulators such as letrozole
8. GnRH modulators such as leuprolide
9. Minoxidil
10. Women planning to conceive.
11. Weight loss of >5 kg within the last 6 months
12. A history of gallstones/gout ( diet may raise urate levels)
13. Substance abuse
14. Known cancer
15. Soya intolerance
16. Current treatment with anti-obesity drugs
17. Diagnosed eating disorder or purging in the last 12 months, based on patient reporting or results of EDI-3 RF questionnaire interpreted by clinical psychologist.
18. Pregnant/ considering pregnancy
19. Participants who have required hospitalisation for depression or are on antipsychotic drugs
20. Peri- or post-menopausal women
21. Lactating women
22. Lactose intolerance
23. Acute illness
24. Prescribed oral steroids or other medication that may affect appetite
25. Hospitalised subjects within 3 months of admission to the study
26. Participation in any other clinical interventional studies in the last 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Free androgen index is measured using a blood test at baseline and 8 weeks later at visit 6.