Functional Bioactive Supplement Effect in Lost Weight Treatment

Obesity and Overweight Clinical Trial

— ALIBIRDII  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024425
• Other study ID #: ALIBIRDII
• Status: Completed
• Phase: Phase 4
• First received: December 27, 2013
• Last updated: November 18, 2015
• Start date: September 2013
• Est. completion date: January 2014

Study information

• Verified date: November 2015
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity and Overweight
• Overweight

Intervention

Dietary Supplement:
• Functional bioactive supplement
1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
• Control supplement

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Appetite and satiety		0 , 3, 6, 9 and 12 weeks	No
Other	Frequent daily evacuations	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)	4 Weeks	No
Other	Adherence and Tolerance Parameters	Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed	0 , 3, 6, 9 and 12 weeks	No
Primary	Changes in body composition	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	12 weeks	No
Secondary	Life style and health status: Life style and physical activity questionnaire		Week 0 and Week 12	No
Secondary	Genetic analysis		Week 0 and Week 12	No
Secondary	Metabolomic analyses		Week 0 and Week 12	No
Secondary	Endothelial function markers	Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure	Week 0 y Week 12	No
Secondary	Satiety hormones	Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY	Week 0 y Week 12	No
Secondary	Inflammatory markers	Inflammatory markers: TNF-a, IL-6, PCR and fibrinogen	Week 0 and Week 12	No
Secondary	Glucose Metabolism	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	No
Secondary	Lipid profile: Cholesterol	Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides	Week 0 and Week 12	No
Secondary	Oxidative Stress Parameters	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	Week 0 and Week 12	No
Secondary	Adverse effects	Adverse effects: transaminases and creatinine	0 , 3, 6, 9 and 12 weeks	Yes

External Links

•   Institute for Health Research IdiPAZ
•   Research group in Nutrition and Functional Foods (NUTRINVEST)