Functional Bioactive Supplement Effect in Lost Weight Treatment (ALIBIRDII)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT02024425
First received: December 27, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Obesity and Overweight
Dietary Supplement: Functional bioactive supplement
Dietary Supplement: Control supplement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Instituto de Investigación Hospital Universitario La Paz:

Primary Outcome Measures:
  • Changes in body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Life style and health status: Life style and physical activity questionnaire [ Time Frame: Week 0 and Week 12 ] [ Designated as safety issue: No ]
  • Genetic analysis [ Time Frame: Week 0 and Week 12 ] [ Designated as safety issue: No ]
  • Metabolomic analyses [ Time Frame: Week 0 and Week 12 ] [ Designated as safety issue: No ]
  • Endothelial function markers [ Time Frame: Week 0 y Week 12 ] [ Designated as safety issue: No ]
    Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure

  • Satiety hormones [ Time Frame: Week 0 y Week 12 ] [ Designated as safety issue: No ]
    Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY

  • Inflammatory markers [ Time Frame: Week 0 and Week 12 ] [ Designated as safety issue: No ]
    Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen

  • Glucose Metabolism [ Time Frame: Week 0 and Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides

  • Oxidative Stress Parameters [ Time Frame: Week 0 and Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Adverse effects: transaminases and creatinine


Other Outcome Measures:
  • Appetite and satiety [ Time Frame: 0 , 3, 6, 9 and 12 weeks ] [ Designated as safety issue: No ]
  • Frequent daily evacuations [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    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)

  • Adherence and Tolerance Parameters [ Time Frame: 0 , 3, 6, 9 and 12 weeks ] [ Designated as safety issue: No ]
    Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed


Enrollment: 109
Study Start Date: September 2013
Estimated Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Dietary Supplement: Functional bioactive supplement
Placebo Comparator: Maltodextrin and saccharose
The control supplement is composed of maltodextrin and saccharose . It has no effect for obese and overweight treatment
Dietary Supplement: Control supplement

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02024425

Locations
Spain
Hospital Universitario La Paz
Madrid, Spain, 28061
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
Principal Investigator: Carmen Gomez Candela, PhD Hospital Universitario La Paz
  More Information

Additional Information:
No publications provided

Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT02024425     History of Changes
Other Study ID Numbers: ALIBIRDII
Study First Received: December 27, 2013
Last Updated: December 27, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Dietary Supplements
Clinical trials
Adult
Women
Functional food
Overweight
Obese
Absorptiometry, Dual X-Ray
Rosmarinus
Oligosaccharides
Lactulose
Bioactive peptide

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014