Functional Bioactive Supplement Effect in Lost Weight Treatment
NCT ID: NCT02024425
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
109 participants
INTERVENTIONAL
2013-09-30
2014-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Functional bioactive supplement
1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
Maltodextrin and saccharose
The control supplement is composed of maltodextrin and saccharose . It has no effect for obese and overweight treatment
Control supplement
Interventions
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Functional bioactive supplement
1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
Control supplement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Overweight (IMC ≥25\<30 Kg/m2) or obese (IMC ≥30\<35 Kg/m2) volunteers
* Signed informed consent.
Exclusion Criteria
* 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;
18 Years
65 Years
FEMALE
No
Sponsors
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Instituto de Investigación Hospital Universitario La Paz
OTHER
Responsible Party
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Principal Investigators
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Carmen Gomez Candela, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Paz
Locations
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Hospital Universitario La Paz
Madrid, Madrid, Spain
Countries
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Related Links
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Institute for Health Research IdiPAZ
Other Identifiers
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ALIBIRDII
Identifier Type: -
Identifier Source: org_study_id