Functional Bioactive Supplement Effect in Lost Weight Treatment

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Obesity and Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: Functional bioactive supplement
* Dietary Supplement: Control supplement


Participation Criteria
=================
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; Subjects with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.); Subjects with mental disease or low cognitive function; Subjects with severe diseases (hepatic, kidney, cancer…); Pregnant women or lactating; Subjects with physical problems complying with the recommendations of physical activity. Subjects with intensive physical activity;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Functional bioactive supplement<br>The functional bioactive supplement is composed of antioxidant extracted from rosemary, oligosaccharides derived from lactulose and bioactive peptides. It will be used for obese and overweight treatment | Dietary Supplement: Functional bioactive supplement<br>* 1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides<br>* Other names: antioxidant, oligosaccharides and bioactive peptides;|
| Placebo Comparator: Maltodextrin and saccharose<br>The control supplement is composed of maltodextrin and saccharose . It has no effect for obese and overweight treatment | Dietary Supplement: Control supplement<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life style and health status: Life style and physical activity questionnaire |  | Week 0 and Week 12 | 
| Genetic analysis |  | Week 0 and Week 12 | 
| Metabolomic analyses |  | Week 0 and Week 12 | 
| Endothelial function markers | Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure | Week 0 y Week 12 | 
| Satiety hormones | Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY | Week 0 y Week 12 | 
| Inflammatory markers | Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen | 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) | Week 0 and Week 12 | 
| Lipid profile: Cholesterol | Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides | 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 | Week 0 and Week 12 | 
| Adverse effects | Adverse effects: transaminases and creatinine | 0 , 3, 6, 9 and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult, Clinical trials, Women, Functional food, Dietary Supplements, Overweight, Obese, Absorptiometry, Dual X-Ray, Rosmarinus, Oligosaccharides, Lactulose, Bioactive peptide