Functional Bioactive Supplement Effect in Lost Weight Treatment

NCT02024425 | Completed Phase 4 DMC

• 1 other identifier: ALIBIRDII
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity and Overweight

Keywords

Clinical trials; Adult; Women; Functional food; Dietary Supplements; Overweight; Obese; Absorptiometry, Dual X-Ray; Rosmarinus; Oligosaccharides; Lactulose; Bioactive peptide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

  Week 0 y Week 12

• Satiety hormones

  Week 0 y Week 12

Other Outcomes (3)

• Appetite and satiety

  0 , 3, 6, 9 and 12 weeks

• Frequent daily evacuations

  4 Weeks

• Adherence and Tolerance Parameters

  0 , 3, 6, 9 and 12 weeks

Study Arms (2)

Functional bioactive supplement

ACTIVE COMPARATOR

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

Maltodextrin and saccharose

PLACEBO COMPARATOR

The control supplement is composed of maltodextrin and saccharose . It has no effect for obese and overweight treatment

Dietary Supplement: Control supplement

Interventions

Functional bioactive supplement DIETARY_SUPPLEMENT

1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides

Also known as: antioxidant, oligosaccharides and bioactive peptides

Functional bioactive supplement

Control supplement DIETARY_SUPPLEMENT

Maltodextrin and saccharose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women from 45 to 75 years old;
• Overweight (IMC ≥25\<30 Kg/m2) or obese (IMC ≥30\<35 Kg/m2) volunteers
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28061, Spain

Location

Related Links

• Institute for Health Research IdiPAZ

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Antioxidants; Oligosaccharides

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals; Polysaccharides; Carbohydrates

Study Officials

• Carmen Gomez Candela, PhD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: December 31, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

ES (1)