The purpose this study is to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treat obese and overweight individuals. The functional bioactive supplement, containing antioxidant extracted from rosemary, oligosaccharides derived from lactulose and bioactive peptides, was developed to satiety control, improves of anti-inflammatory response and antioxidant defense mechanisms as well as to weight loss.
A randomized, parallel, double-blind, controlled was performed to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treatment of obesity and overweight. Women aged between 18 and 65 years with obesity and overweight diagnosis (IMC \>25\<35 kg/m2) were included in the study. The clinical trial will be performed in the Clinical Nutrition Department of La Paz University Hospital, in Madrid. All of the volunteers will receive a dietetic treatment with 1500 Kcal/day and physical activity recommendations during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
109
1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
Hospital Universitario La Paz
Madrid, Madrid, Spain
Changes in body composition
Clinical response - changes in body composition: weight, waist circumference and Absorptiometry, Dual X-Ray.The primary outcome result measurement was the lost weight, changes in body composition
Time frame: 12 weeks
Life style and health status: Life style and physical activity questionnaire
Time frame: Week 0 and Week 12
Genetic analysis
Time frame: Week 0 and Week 12
Metabolomic analyses
Time frame: Week 0 and Week 12
Endothelial function markers
Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure
Time frame: Week 0 y Week 12
Satiety hormones
Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY
Time frame: Week 0 y Week 12
Inflammatory markers
Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen
Time frame: Week 0 and Week 12
Glucose Metabolism
Glucose Metabolism: glucose, basal insulin, HbA1c (in diabetic patients), HOMA index (glycemic insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5)
Time frame: Week 0 and Week 12
Lipid profile: Cholesterol
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides
Time frame: Week 0 and Week 12
Oxidative Stress Parameters
Oxidative Stress Parameters: plasma antioxidant capacity (FRAP, ferric reducing antioxidant power) and lipidic peroxidation (TBARS, thiobarbituric acid reactive substances assay), oxidized LDL, PON1, F2-isoprostanes
Time frame: Week 0 and Week 12
Adverse effects
Adverse effects: transaminases and creatinine
Time frame: 0 , 3, 6, 9 and 12 weeks