Functional Bioactive Supplement Effect in Lost Weight Treatment (ALIBIRDII)

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Madrid, Spain, 28061
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
Other Names:
  • antioxidant, oligosaccharides and bioactive peptides
Placebo Comparator: Maltodextrin and saccharose
The control supplement is composed of maltodextrin and saccharose . It has no effect for obese and overweight treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite and satiety
Time Frame: 0 , 3, 6, 9 and 12 weeks
0 , 3, 6, 9 and 12 weeks
Frequent daily evacuations
Time Frame: 4 Weeks
Frequent daily evacuations, format and consistency of the feces, total and segmental transit time. The format and consistency of the feces was evaluated in accordance with the Bristol Stool Form Scale (stool are rated based on water content of the feces, with 1 meaning hard stools to 7 meaning liquid stools)
4 Weeks
Adherence and Tolerance Parameters
Time Frame: 0 , 3, 6, 9 and 12 weeks
Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed
0 , 3, 6, 9 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carmen Gomez Candela, PhD, Hospital Universitario La Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

December 27, 2013

First Submitted That Met QC Criteria

December 27, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 18, 2015

Last Verified

November 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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