- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02024425
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Madrid, Spain, 28061
- Hospital Universitario La Paz
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
Other Names:
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Placebo Comparator: Maltodextrin and saccharose
The control supplement is composed of maltodextrin and saccharose .
It has no effect for obese and overweight treatment
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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
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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
|
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Metabolomic analyses
Time Frame: Week 0 and Week 12
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Week 0 and Week 12
|
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Endothelial function markers
Time Frame: Week 0 y Week 12
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Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure
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Week 0 y Week 12
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Satiety hormones
Time Frame: Week 0 y Week 12
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Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY
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Week 0 y Week 12
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Inflammatory markers
Time Frame: Week 0 and Week 12
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Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen
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Week 0 and Week 12
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Glucose Metabolism
Time Frame: Week 0 and Week 12
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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
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Lipid profile: Cholesterol
Time Frame: Week 0 and Week 12
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Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides
|
Week 0 and Week 12
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Oxidative Stress Parameters
Time Frame: Week 0 and Week 12
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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
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Week 0 and Week 12
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Adverse effects
Time Frame: 0 , 3, 6, 9 and 12 weeks
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Adverse effects: transaminases and creatinine
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0 , 3, 6, 9 and 12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appetite and satiety
Time Frame: 0 , 3, 6, 9 and 12 weeks
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0 , 3, 6, 9 and 12 weeks
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Frequent daily evacuations
Time Frame: 4 Weeks
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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)
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4 Weeks
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Adherence and Tolerance Parameters
Time Frame: 0 , 3, 6, 9 and 12 weeks
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Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed
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0 , 3, 6, 9 and 12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Carmen Gomez Candela, PhD, Hospital Universitario La Paz
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALIBIRDII
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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