ALIBIRDII: Functional Bioactive Supplement Effect in Lost Weight Treatment

Sponsor

Instituto de Investigación Hospital Universitario La Paz (Other)

Overall Status

Completed

CT.gov ID

NCT02024425

Collaborator

(none)

109

Enrollment

Location

Arms

Duration (Months)

27.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity and Overweight	Dietary Supplement: Functional bioactive supplement Dietary Supplement: Control supplement	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

109 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

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	Dietary Supplement: Functional bioactive supplement 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	Dietary Supplement: Control supplement

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

Dietary Supplement: Functional bioactive supplement

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

Dietary Supplement: Control supplement

Outcome Measures

Primary Outcome Measures

Changes in body composition [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

Secondary Outcome Measures

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]
Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure
Satiety hormones [Week 0 y Week 12]
Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY
Inflammatory markers [Week 0 and Week 12]
Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen
Glucose Metabolism [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)
Lipid profile: Cholesterol [Week 0 and Week 12]
Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides
Oxidative Stress Parameters [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
Adverse effects [0 , 3, 6, 9 and 12 weeks]
Adverse effects: transaminases and creatinine

Other Outcome Measures

Appetite and satiety [0 , 3, 6, 9 and 12 weeks]
Frequent daily evacuations [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)
Adherence and Tolerance Parameters [0 , 3, 6, 9 and 12 weeks]
Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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;