The effect of selenium supplementation alongside a balanced low-calorie diet in patients with obesity
Not Applicable
Completed
- Conditions
- Overweight/obesityNutritional, Metabolic, EndocrineObesity
- Registration Number
- ISRCTN61060735
- Lead Sponsor
- niversity of Padua
- Brief Summary
2020 results in https://pubmed.ncbi.nlm.nih.gov/32565792/ (added 23/06/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
1. Body mass index (BMI) =25 kg/m2
2. Aged 18-65 years
3. Referred to the Endocrinology Unit of the University of Padua for the purpose of losing weight
Exclusion Criteria
1. Smoking
2. Treatment with levothyroxine or any medication modifying thyroid function (e.g. corticosteroids, amiodarone, propranolol, lithium)
3. TSH levels outside the normal laboratory range
4. Severe cardiopathy treated with antiarrhythmics or vasodilators
5. Pregnancy or breastfeeding; previous or current malignancies
6. Severe eating disorders
7. Liver failure
8. Pharmacological treatment for obesity
9. Chronic inflammatory disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body mass composition will be assessed with a bioelectrical impedance analysis (BIA) using the Biavector® nomogram and Bodygram™ software (Akern Bioresearch s.r.l.), recording values for lean mass, fat mass, and muscle mass at baseline and 3 months
- Secondary Outcome Measures
Name Time Method <br> 1. Leptin levels will be assessed using blood samples taken at baseline and 3 months<br> 2. Weight will be measured during clinical assessment at baseline and 3 months<br> 3. Mood will be assessed using the Psychological General Well-Being Index (PGWBI) questionnaire at baseline and 3 months<br> 4. Thyroid function will be assessed using blood samples taken at baseline and 3 months<br>