PCOS and obesity Nutritional, Metabolic, Endocrine PCOS and obesity
Conditions
Interventions
Participants are randomised to one of two study arms using the website randomisation.com.
Arm 1 – Very low calorie diet (VLCD): Shakes or soups will be consumed up to 4 times per day providing 800kca
Sponsors
Hull and East Yorkshire Hospitals
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Free androgen index is measured using a blood test at baseline and 8 weeks later at visit 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total body weight (kg) is measured using Marsden MS-4202L electronic scales at each patient visit, throughout the trial 2. Body composition is assessed using a DEXA scan, at baseline and 8 weeks later at visit 6 3. Waist hip ratio is measured using abdominal circumference tape measure. The tape measure, lying flat will be wrapped around the participant’s waist at the midway point between the bottom of the ribs and the top of the hips (iliac crest). These measurements will be then be used to calculate the waist to hip ratio at baseline and 8 weeks later at visit 6. 4. hsC Reactive Protein (CRP) levels are measured is measured using a blood test at baseline and 8 weeks later at visit 6 5. Serum androgens (androstenedione, 17 hydroxy progesterone, DHEAS) are is measured using a blood test at baseline and 8 weeks later at visit 6 6. Fasting lipids profile is measured using is measured using a blood test at baseline and 8 weeks later at visit 6 7. Vascular function is assessed using the EndoPAT 2000 test at baseline and 8 weeks later at visit 6 8. Micro particles are measured using a blood test at baseline and 8 weeks later at visit 6 9. Glucose and insulin levels are measured using OGTT – consuming a glucose load when fasted followed by a blood test. The test will be performed at baseline and 8 weeks later at visit 6. Hba1c and HOMA - IR will be measured via a blood test at baseline and 8 weeks later at visit 6. 10. Compliance to total diet replacement shakes will be measured by the dietitian and the number or unused sachets returned by the patient at visit 4 and 6 | — |
Countries
England, United Kingdom
Outcome results
None listed