Obesity and OverweightPhase 4ALIBIRDIINCT02024425
Functional Bioactive Supplement Effect in Lost Weight Treatment
A Phase 4 study testing Functional bioactive supplement in people with Obesity and Overweight, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Functional bioactive supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Jan 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women from 45 to 75 years old;
- Overweight (IMC ≥25<30 Kg/m2) or obese (IMC ≥30<35 Kg/m2) volunteers
- Signed informed consent.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Functional bioactive supplement, Control supplement
- Keywords
- Clinical trials, Adult, Women, Functional food, Dietary Supplements, Overweight, Obese, Absorptiometry, Dual X-Ray, Rosmarinus, Oligosaccharides, Lactulose, Bioactive peptide
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional bioactive supplementDietary supplement
Also called antioxidant, oligosaccharides and bioactive peptides
1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
Control supplementDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Functional bioactive supplement | Active comparator | 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 Receives: Dietary Supplement: Functional bioactive supplement |
| Maltodextrin and saccharose | Placebo comparator | The control supplement is composed of maltodextrin and saccharose . It has no effect for obese and overweight treatment Receives: Dietary Supplement: Control supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (10)
Life style and health status: Life style and physical activity questionnaire
Measured: Week 0 and Week 12
Genetic analysis
Measured: Week 0 and Week 12
Metabolomic analyses
Measured: Week 0 and Week 12
Endothelial function markers
Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure
Measured: Week 0 y Week 12
Satiety hormones
Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY
Measured: Week 0 y Week 12
Inflammatory markers
Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen
Measured: Week 0 and Week 12
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)
Measured: Week 0 and Week 12
Lipid profile: Cholesterol
Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides
Measured: Week 0 and Week 12
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
Measured: Week 0 and Week 12
Adverse effects
Adverse effects: transaminases and creatinine
Measured: 0 , 3, 6, 9 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Gomez Candela, PhD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024425
- Sponsor's protocol ID
- ALIBIRDII
- Acronym
- ALIBIRDII
- Status last verified
- Nov 2015
- First submitted
- 27 Dec 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02024425
- Acronym / sponsor ID
- ALIBIRDII / ALIBIRDII
- Conditions
- Obesity and Overweight
- Keywords
- Clinical trials, Adult, Women, Functional food, Dietary Supplements, Overweight, Obese, Absorptiometry, Dual X-Ray
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional bioactive supplement | Active comparator | Dietary Supplement: Functional bioactive supplementThe 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 |
| Maltodextrin and saccharose | Placebo comparator | Dietary Supplement: Control supplementThe control supplement is composed of maltodextrin and saccharose . It has no effect for obese and overweight treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women from 45 to 75 years old;
- Overweight (IMC ≥25<30 Kg/m2) or obese (IMC ≥30<35 Kg/m2) volunteers
- Signed informed consent.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional bioactive supplementAlso: antioxidant, oligosaccharides and bioactive peptides1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides | Dietary supplement | Functional bioactive supplement |
| Control supplement | Dietary supplement | Maltodextrin and saccharose |
Primary outcome
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
10 secondary outcomes
Life style and health status: Life style and physical activity questionnaire
Time frame: Week 0 and Week 12
Genetic analysis
Time frame: Week 0 and Week 12
Metabolomic analyses
Time frame: Week 0 and Week 12
Endothelial function markers
Time frame: Week 0 y Week 12
Satiety hormones
Time frame: Week 0 y Week 12
Inflammatory markers
Time frame: Week 0 and Week 12
Glucose Metabolism
Time frame: Week 0 and Week 12
Lipid profile: Cholesterol
Time frame: Week 0 and Week 12
Oxidative Stress Parameters
Time frame: Week 0 and Week 12
Adverse effects
Time frame: 0 , 3, 6, 9 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Institute for Health Research IdiPAZLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Gomez Candela, PhD principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Functional bioactive supplement in people with Obesity and Overweight, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body composition (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.