Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effect of a Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects (POMEcardio)

13. april 2015 opdateret af: Juan Carlos Espín de Gea, National Research Council, Spain

Effect of an Ellagitannin Rich Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects. A Double-blind, Cross-over, Dose-response, Randomized, Placebo-controlled Trial (The POMEcardio Study)

The investigators objective is to carry out a placebo-controlled, dose-response, randomized clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular disease risk in overweight adult subjects upon the consumption of pomegranate extract.

The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory markers. The correlation between the effect exerted and the subjects' microbiota (capacity to produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of urolithins on the effects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Murcia, Spanien, 30107
        • UCAM (San Antonio Catholic University from Murcia)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Aged 40-65 years
  • Body mass index (BMI) >27 kg/m2
  • Healthy status (no illness in the previous 3-months).

Exclusion Criteria:

  • Smoking.
  • Pregnancy/lactation.
  • Severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, Crohn disease etc.).
  • Previous gastrointestinal surgery
  • Recent use of antibiotics (within 1-month prior to the study)
  • Suspected hypersensitivity to pomegranate or any of its components
  • Consumption of nutraceuticals, botanical extracts or other vitamin supplements or taking medication.
  • Regular consumption of ellagitannin-containing foodstuffs (walnuts, pomegranate, strawberries, raspberries, oak-aged red wine) (after filling a food-frequency questionnaire).
  • Intake of ellagitannins-containing foodstuffs the week before the pharmacokinetic intervention.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Pomegranate extract

Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo.

Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks.
Kosttilskud: Pomegranate extract-first dose-Group A
Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
Andre navne:
  • Group A consumes pomegranate extract (first dose)
Kosttilskud: Pomegranate extract-first dose-Group B
After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
Andre navne:
  • Group B consumes pomegranate extract (first dose)
Kosttilskud: Pomegranate extract-second dose-Group A
After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
Andre navne:
  • Group A consumes pomegranate extract (second dose)
Kosttilskud: Pomegranate extract-second dose-Group B
After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
Andre navne:
  • Group B consumes pomegranate extract (second dose)
Placebo komparator: Placebo

Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo.

Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks.
Kosttilskud: Placebo-first dose-Group B
Group B will consume 1 daily capsules of placebo for 3 weeks.
Andre navne:
  • Group B consumes placebo (first dose)
Kosttilskud: Placebo-first dose-Group A
After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
Andre navne:
  • Group A consumes placebo (first dose)
Kosttilskud: Placebo-second dose-Group B
After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
Andre navne:
  • Group B consumes placebo (second dose)
Kosttilskud: Placebo-second dose-Group A
After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
Andre navne:
  • Group A consumes placebo (second dose)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in serum oxidized LDL-cholesterol concentration
Tidsramme: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Effect on circulating levels of oxidized particles of LDL-cholesterol
Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in serum lipids and lipoproteins levels
Tidsramme: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Effects on serum total cholesterol, LDL-cholesterol, HDL-cholesterol and apolipoproteins A1 (ApoA1), B (ApoB) and E (ApoE).
Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Change in serum sICAM, sVCAM and hsCRP
Tidsramme: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Effect on soluble intercellular adhesion molecule (sICAM), soluble vascular adhesion molecule (sVCAM) and high-sensitivity C-reactive protein (hsCRP)
Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Change in fecal microbiota
Tidsramme: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Prebiotic effect: Change in short fatty acids, bifidobacteria, lactobacilli and other selected species in feces
Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Number of volunteers with adverse events as a measure of safety and tolerability
Tidsramme: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
  • Change in markers involved in hepatic and renal functions: GGT, AST, ALP, ALT, CPK, urate, creatinin, albumin, bilirubin, LDH.
  • Change in hematological variables: leucocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, mean corpuscular volume, mean platelet volume, platelets, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration.
  • Intolerance, dyspepsia, allergic reactions, constipation, diarrhea, abdominal pain, nausea.
Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Change in phenolics and derived metabolites in plasma, feces and urine.
Tidsramme: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Dose-response effect of pomegranate intake on phenolics and gut-microbiota derived metabolites in plasma, feces and urine.
Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Research Council, Spain

Samarbejdspartnere

Universidad Católica San Antonio de Murcia
The Scientific and Technological Research Council of Turkey

Efterforskere

  • Ledende efterforsker: Dr. Juan Carlos Espín, PhD, National Research Council (CEBAS-CSIC, Murcia, Spain)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2014

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

7. februar 2014

Først indsendt, der opfyldte QC-kriterier

11. februar 2014

Først opslået (Skøn)

12. februar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CEBAS-CSIC-4

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner