Clinical trial NCT02024425: Functional Bioactive Supplement Effect in Lost Weight 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity and Overweight
Keywords: Clinical trials
Adult
Women
Functional food
Dietary Supplements
Overweight
Obese
Absorptiometry, Dual X-Ray
Rosmarinus
Oligosaccharides
Lactulose
Bioactive peptide
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Changes in body composition
timeFrame: 12 weeks
Secondary outcomes:
measure: Life style and health status: Life style and physical activity questionnaire
timeFrame: Week 0 and Week 12
measure: Genetic analysis
timeFrame: Week 0 and Week 12
measure: Metabolomic analyses
timeFrame: Week 0 and Week 12
measure: Endothelial function markers
timeFrame: Week 0 y Week 12
measure: Satiety hormones
timeFrame: Week 0 y Week 12
measure: Inflammatory markers
timeFrame: Week 0 and Week 12
measure: Glucose Metabolism
timeFrame: Week 0 and Week 12
measure: Lipid profile: Cholesterol
timeFrame: Week 0 and Week 12
measure: Oxidative Stress Parameters
timeFrame: Week 0 and Week 12
measure: Adverse effects
timeFrame: 0 , 3, 6, 9 and 12 weeks
Other outcomes:
measure: Appetite and satiety
timeFrame: 0 , 3, 6, 9 and 12 weeks
measure: Frequent daily evacuations
timeFrame: 4 Weeks
measure: Adherence and Tolerance Parameters
timeFrame: 0 , 3, 6, 9 and 12 weeks
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Carmen Gomez Candela, PhD
role: PRINCIPAL_INVESTIGATOR
References: