Functional Bioactive Supplement Effect in Lost Weight Treatment

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2013

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.

Interventions

  • Dietary Supplement: Functional bioactive supplement
    • 1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
  • Dietary Supplement: Control supplement

Arms, Groups and Cohorts

  • Active Comparator: 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
  • Placebo Comparator: Maltodextrin and saccharose
    • The control supplement is composed of maltodextrin and saccharose . It has no effect for obese and overweight treatment

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
    • Time Frame: Week 0 y Week 12
    • Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure
  • Satiety hormones
    • Time Frame: Week 0 y Week 12
    • Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY
  • Inflammatory markers
    • Time Frame: Week 0 and Week 12
    • Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen
  • Glucose Metabolism
    • Time Frame: 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
    • Time Frame: Week 0 and Week 12
    • Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides
  • Oxidative Stress Parameters
    • Time Frame: 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
    • Time Frame: 0 , 3, 6, 9 and 12 weeks
    • Adverse effects: transaminases and creatinine

Participating in This Clinical Trial

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;

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto de Investigación Hospital Universitario La Paz
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Carmen Gomez Candela, PhD, Principal Investigator, Hospital Universitario La Paz

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