Reversing PCOS

• Research type

  Research Study

• Full title

  A randomised controlled trial to investigate the effect of very low calorie diet (VLCD) vs. an energy deficit approach weight loss diet, over 8 weeks, in obese women with polycystic ovarian syndrome (PCOS).

• IRAS ID

  215253

• Contact name

  Thozhukat Sathypalan

• Sponsor organisation

  Hull and East Yorkshire Hospitals NHS Trust

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Title - A randomised controlled trial to investigate the effect of very low calorie diet (VLCD) vs. an energy deficit approach weight loss diet, over 8 weeks, in obese women with polycystic ovarian syndrome (PCOS).

  Females aged between 18-45 years of age diagnosed with PCOS will be randomised to a VLCD providing 800kcal day in the form of drinks and shakes which are nutritionally complete for micro-nutrients and vitamins ;Or an energy deficit approach weight loss diet i.e. the patients daily energy requirements minus 600kcal/day as calculated by the dietitian. Energy requirements are calculated based on the patient based on age, gender, weight ( kg) and activity levels. The VLCD will provide 800 kcal a day, in the form of 4 soups and drink made from pre prepared sachets provided by the Cambridge weight plan ™ company. 12 flavours of drinks and 6 flavours of soup are available. Each meal replacement provides 200kcal, 21g carbohydrate, 15g of protein, 3-4 g fats and are nutritionally complete for micronutrients. They are specifically designed to be used for total meal replacement. Once the patient has completed the 1st stage of the diet ( 8weeks) they will attend to see the dietitian for a further 8 weeks to complete a stepped return (increase of 200kcal/2weeks) to an isocaloric dietary intake.
  The research will be conducted at a single site - The Centre for Diabetes, Endocrinology and Metabolism research, Hull Royal infirmary. The intervention stage of the trial will last for 8 weeks. The patient will then be followed up for a period of 8 weeks. The patient may be involved in the trial for up to 18 weeks dependent on time taken to screen and consent. The main outcome measures are decreases in free androgen index and reductions in weight (kg) and total body weight loss (%).

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  16/YH/0518

• Date of REC Opinion

  14 Mar 2017

• REC opinion

  Further Information Favourable Opinion