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

13. april 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

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

Studiesteder

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

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

40 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

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: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: Pomegranate extract-first dose-Group A
Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
Andre navn:
  • Group A consumes pomegranate extract (first dose)
Kosttilskudd: 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 navn:
  • Group B consumes pomegranate extract (first dose)
Kosttilskudd: 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 navn:
  • Group A consumes pomegranate extract (second dose)
Kosttilskudd: 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 navn:
  • 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.
Kosttilskudd: Placebo-first dose-Group B
Group B will consume 1 daily capsules of placebo for 3 weeks.
Andre navn:
  • Group B consumes placebo (first dose)
Kosttilskudd: Placebo-first dose-Group A
After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
Andre navn:
  • Group A consumes placebo (first dose)
Kosttilskudd: Placebo-second dose-Group B
After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
Andre navn:
  • Group B consumes placebo (second dose)
Kosttilskudd: Placebo-second dose-Group A
After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
Andre navn:
  • Group A consumes placebo (second dose)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

National Research Council, Spain

Samarbeidspartnere

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

Etterforskere

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

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. februar 2014

Primær fullføring (Faktiske)

1. august 2014

Studiet fullført (Faktiske)

1. desember 2014

Datoer for studieregistrering

Først innsendt

7. februar 2014

Først innsendt som oppfylte QC-kriteriene

11. februar 2014

Først lagt ut (Anslag)

12. februar 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. april 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. april 2015

Sist bekreftet

1. april 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CEBAS-CSIC-4

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