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Functional Bioactive Supplement Effect in Lost Weight Treatment (ALIBIRDII)

Primary Purpose

Obesity and Overweight

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Functional bioactive supplement
Control supplement
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity and Overweight focused on measuring Clinical trials, Adult, Women, Functional food, Dietary Supplements, Overweight, Obese, Absorptiometry, Dual X-Ray, Rosmarinus, Oligosaccharides, Lactulose, Bioactive peptide

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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;

Sites / Locations

  • Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Functional bioactive supplement

Maltodextrin and saccharose

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Life style and health status: Life style and physical activity questionnaire
Genetic analysis
Metabolomic analyses
Endothelial function markers
Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure
Satiety hormones
Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY
Inflammatory markers
Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen
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)
Lipid profile: Cholesterol
Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides
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
Adverse effects
Adverse effects: transaminases and creatinine

Full Information

First Posted
December 27, 2013
Last Updated
November 18, 2015
Sponsor
Instituto de Investigación Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT02024425
Brief Title
Functional Bioactive Supplement Effect in Lost Weight Treatment
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity and Overweight
Keywords
Clinical trials, Adult, Women, Functional food, Dietary Supplements, Overweight, Obese, Absorptiometry, Dual X-Ray, Rosmarinus, Oligosaccharides, Lactulose, Bioactive peptide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional bioactive supplement
Arm Type
Active Comparator
Arm 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
Arm Title
Maltodextrin and saccharose
Arm Type
Placebo Comparator
Arm Description
The control supplement is composed of maltodextrin and saccharose . It has no effect for obese and overweight treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Functional bioactive supplement
Other Intervention Name(s)
antioxidant, oligosaccharides and bioactive peptides
Intervention Description
1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
Intervention Type
Dietary Supplement
Intervention Name(s)
Control supplement
Primary Outcome Measure Information:
Title
Changes in body composition
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Life style and health status: Life style and physical activity questionnaire
Time Frame
Week 0 and Week 12
Title
Genetic analysis
Time Frame
Week 0 and Week 12
Title
Metabolomic analyses
Time Frame
Week 0 and Week 12
Title
Endothelial function markers
Description
Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure
Time Frame
Week 0 y Week 12
Title
Satiety hormones
Description
Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY
Time Frame
Week 0 y Week 12
Title
Inflammatory markers
Description
Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen
Time Frame
Week 0 and Week 12
Title
Glucose Metabolism
Description
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)
Time Frame
Week 0 and Week 12
Title
Lipid profile: Cholesterol
Description
Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides
Time Frame
Week 0 and Week 12
Title
Oxidative Stress Parameters
Description
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
Time Frame
Week 0 and Week 12
Title
Adverse effects
Description
Adverse effects: transaminases and creatinine
Time Frame
0 , 3, 6, 9 and 12 weeks
Other Pre-specified Outcome Measures:
Title
Appetite and satiety
Time Frame
0 , 3, 6, 9 and 12 weeks
Title
Frequent daily evacuations
Description
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)
Time Frame
4 Weeks
Title
Adherence and Tolerance Parameters
Description
Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed
Time Frame
0 , 3, 6, 9 and 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gomez Candela, PhD
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28061
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.idipaz.es
Description
Institute for Health Research IdiPAZ
URL
http://www.nutrinvest.com
Description
Research group in Nutrition and Functional Foods (NUTRINVEST)

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Functional Bioactive Supplement Effect in Lost Weight Treatment

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