Functional Bioactive Supplement Effect in Lost Weight Treatment

Phase 4

Completed

• Conditions: Obesity and Overweight
• Interventions: Dietary Supplement: Control supplement; Dietary Supplement: Functional bioactive supplement

• Registration Number: NCT02024425
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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.

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2013-12
• Study First Submitted: 2013-12-27
• Study First Submitted QC: 2013-12-27
• Study First Posted: 2013-12-31
• Study Completion: 2014-01
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-18
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maltodextrin and saccharose	Control supplement	The control supplement is composed of maltodextrin and saccharose . It has no effect for obese and overweight treatment
Functional bioactive supplement	Functional bioactive supplement	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

Primary Outcome Measures

Name	Time	Method
Changes in body composition	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 Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain