NCT02024425

Functional Bioactive Supplement Effect in Lost Weight Treatment

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity and Overweight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Functional bioactive supplement	1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
DIETARY_SUPPLEMENT	Control supplement

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2013-12-31
• Last updated: 2015-11-20

Locations

1 site across 1 country: Spain