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Functional Bioactive Supplement Effect in Lost Weight Treatment (ALIBIRDII)

18. november 2015 oppdatert av: Instituto de Investigación Hospital Universitario La Paz

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

109

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
      • Madrid, Spania, 28061
        • Hospital Universitario La Paz

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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;

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Functional bioactive supplement
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
Kosttilskudd: Functional bioactive supplement
1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
Andre navn:
  • antioxidant, oligosaccharides and bioactive peptides
Placebo komparator: Maltodextrin and saccharose
The control supplement is composed of maltodextrin and saccharose . It has no effect for obese and overweight treatment
Kosttilskudd: Control supplement

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in body composition
Tidsramme: 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
12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Life style and health status: Life style and physical activity questionnaire
Tidsramme: Week 0 and Week 12
Week 0 and Week 12
Genetic analysis
Tidsramme: Week 0 and Week 12
Week 0 and Week 12
Metabolomic analyses
Tidsramme: Week 0 and Week 12
Week 0 and Week 12
Endothelial function markers
Tidsramme: Week 0 y Week 12
Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure
Week 0 y Week 12
Satiety hormones
Tidsramme: Week 0 y Week 12
Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY
Week 0 y Week 12
Inflammatory markers
Tidsramme: Week 0 and Week 12
Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen
Week 0 and Week 12
Glucose Metabolism
Tidsramme: 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)
Week 0 and Week 12
Lipid profile: Cholesterol
Tidsramme: Week 0 and Week 12
Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides
Week 0 and Week 12
Oxidative Stress Parameters
Tidsramme: 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
Week 0 and Week 12
Adverse effects
Tidsramme: 0 , 3, 6, 9 and 12 weeks
Adverse effects: transaminases and creatinine
0 , 3, 6, 9 and 12 weeks

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Appetite and satiety
Tidsramme: 0 , 3, 6, 9 and 12 weeks
0 , 3, 6, 9 and 12 weeks
Frequent daily evacuations
Tidsramme: 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)
4 Weeks
Adherence and Tolerance Parameters
Tidsramme: 0 , 3, 6, 9 and 12 weeks
Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed
0 , 3, 6, 9 and 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Etterforskere

  • Hovedetterforsker: Carmen Gomez Candela, PhD, Hospital Universitario La Paz

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2013

Primær fullføring (Faktiske)

1. desember 2013

Studiet fullført (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først innsendt

27. desember 2013

Først innsendt som oppfylte QC-kriteriene

27. desember 2013

Først lagt ut (Anslag)

31. desember 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. november 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. november 2015

Sist bekreftet

1. november 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ALIBIRDII

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