Comparison of varying dietary interventions in an obese populatio
Completed
- Conditions
- ObesityNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN09760867
- Lead Sponsor
- The Robert Gordon University (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
1. Men and women older than 18 years of age
2. Body Mass Index (BMI) greater than or equal to 35 kg/m^2
Exclusion Criteria
1. History of hepatic or renal disease
2. Cancer
3. Current pregnancy/lactating
4. On anti-depressants or anti-obesity medication
5. Eating disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight loss, measured in kilograms before screening, at screening and 3 and 9 months post-screening.
- Secondary Outcome Measures
Name Time Method 1. Changes in cardiovascular risk, measured by looking at total cholesterol, triacylglycerols, high density lipoprotein (HDL), low density lipoprotein (LDL), fasting glucose (all in mmol/L), fasting insulin (uU/ml), HbA1c (%) waist circumference (cm), blood pressure (mmHg) <br>2. Liver and kidney function; liver function assessed by measuring albumin (g/L), total bilirubin (umol/L), alkaline phosphatase, alanine aminotransferase and gamma-glutamyl transferase (U/L). For kidney function urea (mmol/L) and creatinine (umol/L) were measured and the estimated glomerular filtration was calculated.<br>3. Quality of life, measured using the following questionnaires: Physical activity (in house), the Dutch Eating Behaviour, the World Health Organization (WHO) quality of life, the Beck Depression Inventory, General Health, Lee fatigue scale and the Epworth Sleepiness Scale<br>4. Changes in adipokines<br><br>All measured before screening, at screening and 3 and 9 months post-screening.