A Randomized, Double-blind Trial to Evaluate the Effect of a Functional Bioactive Supplement Associated With a Hypocaloric Equilibrated Diet to Treatment of Obese and Overweight Individuals
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Obesity and Overweight
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Changes in body composition
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women from 45 to 75 years old;
- •Overweight (IMC ≥25\<30 Kg/m2) or obese (IMC ≥30\<35 Kg/m2) volunteers
- •Signed informed consent.
Exclusion Criteria
- •Subjects with drug consumption (lipid-lowering, oral hypoglycemic agents and / or hypertensive) in less than one month period;
- •Subjects with Diabetes Mellitus insulin dependent;
- •Individuals that stop smoking in the next 12 weeks (during the study);
- •Subjects with increased alcohol consumption (\> 1 glass of vine);
- •Subjects that consume drugs, vitamins, minerals, prebiotics or/and probiotics that interfere with the body's response to the extracts in the 2 weeks before to baseline;
- •Subjects with drugs consumption special diet due to disease as celiac disease, chronic renal failure, etc;
- •Subjects with disorders associated with eating behaviour;
- •Subjects with drugs or supplements consumption to weight lost;
- •Subjects with physical problems complying with the recommendations of physical activity and diet indicated;
- •Subjects who refuse to perform the indicated dietary changes throughout the study;
Outcomes
Primary Outcomes
Changes in body composition
Time Frame: 12 weeks
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
Secondary Outcomes
- Metabolomic analyses(Week 0 and Week 12)
- Life style and health status: Life style and physical activity questionnaire(Week 0 and Week 12)
- Genetic analysis(Week 0 and Week 12)
- Endothelial function markers(Week 0 y Week 12)
- Satiety hormones(Week 0 y Week 12)
- Inflammatory markers(Week 0 and Week 12)
- Glucose Metabolism(Week 0 and Week 12)
- Lipid profile: Cholesterol(Week 0 and Week 12)
- Oxidative Stress Parameters(Week 0 and Week 12)
- Adverse effects(0 , 3, 6, 9 and 12 weeks)