Functional Bioactive Supplement Effect in Lost Weight Treatment (ALIBIRDII)

Instituto de Investigación Hospital Universitario La Paz

Status and phase: Completed; Phase 4

Conditions: Obesity and Overweight

Treatments: Dietary Supplement: Functional bioactive supplement; Dietary Supplement: Control supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02024425

ALIBIRDII

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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109 participants in 2 patient groups, including a placebo group

Functional bioactive supplement

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Functional bioactive supplement

Maltodextrin and saccharose

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Control supplement