Skip to main content
OpenTrials
Completed

NCT Number: NCT02024425

Functional Bioactive Supplement Effect in Lost Weight Treatment

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario La Paz

Madrid, 28061, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Functional bioactive supplement

Dietary 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

Control supplement

Dietary Supplement

Primary outcomes

  1. Changes in body composition

    Time frame: 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 outcomes

  1. Life style and health status: Life style and physical activity questionnaire

    Time frame: Week 0 and Week 12

  2. Genetic analysis

    Time frame: Week 0 and Week 12

  3. Metabolomic analyses

    Time frame: Week 0 and Week 12

  4. Endothelial function markers

    Time frame: Week 0 y Week 12

    Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure

  5. Satiety hormones

    Time frame: Week 0 y Week 12

    Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY

  6. Inflammatory markers

    Time frame: Week 0 and Week 12

    Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen

  7. Glucose Metabolism

    Time frame: 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)

  8. Lipid profile: Cholesterol

    Time frame: Week 0 and Week 12

    Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides

  9. Oxidative Stress Parameters

    Time frame: 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

  10. Adverse effects

    Time frame: 0 , 3, 6, 9 and 12 weeks

    Adverse effects: transaminases and creatinine

Other outcomes

  1. Appetite and satiety

    Time frame: 0 , 3, 6, 9 and 12 weeks

  2. Frequent daily evacuations

    Time frame: 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)

  3. Adherence and Tolerance Parameters

    Time frame: 0 , 3, 6, 9 and 12 weeks

    Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study 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

Acronym: ALIBIRDII

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Dec 31, 2013
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.