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Healthy Effects of an Innovative Probiotic Pasta (SFLABPASTA)

30 octobre 2018 mis à jour par: Nicoletta Pellegrini, PhD, University of Parma
The aim of the project was the evaluation of the antioxidant and anti-inflammatory effects of a whole grain pasta, enriched in barley β-glucans and fortified with strains of Bacillus coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized controlled trial.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Epidemiological evidences indicate that consumption of whole grains products is associated to a decreased risk for common chronic diseases, as cardiovascular diseases, diabetes, obesity, hypertension and metabolic syndrome. In the present study a whole grain pasta was supplemented with prebiotics and probiotics 'ad hoc' formulated. In detail, pasta was industrially developed after the identification of particular cultivars of wheat and barley, rich in carotenoids, β-glucans (2.6 g/100g pasta), not soluble fibers and antioxidants. Further, pasta was supplemented with spores of Bacillus coagulans, a putative probiotic microorganism, belonging to Lactobacillus family. It is well demonstrated the ability of this microorganism to survive to technological processes and to upper gastro-intesinal tract, in order to exert beneficial effects in the lower gut, as anti-microbial activity, increasing immunological defences as well as improvements in intestinal regularity. Conversely, the control pasta was made from the same cultivar of grain and by the same technological process, but without any supplementation.

In this parallel randomized controlled one arm trial, 40 healthy volunteers were randomly allocated for the consumption of the two kind of pasta once a day, for 12 weeks. At the beginning of the study and every 4 weeks, subjects were asked to provide blood, urine and feces for the evaluation of:

  • blood inflammation markers;
  • blood lipid and carbohydrate profile;
  • blood and urine markers of cardiovascular risk;
  • feces profile of microbiota and detection of markers for the healthiness of the gut.

In addition, volunteers filled in different questionnaires regarding their dietary habits, the physical activity and the gut healthiness.

Type d'étude

Interventionnel

Inscription (Réel)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Italie
      • Parma, Italie, 43124
        • University of Parma
    • PR
      • Parma, PR, Italie, 43124
        • University of Parma - Department of Food Sciences

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

30 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Overweight / Obesity
  • Lower consumers of fruit and vegetables

Exclusion Criteria:

  • Antibiotic treatment within 3 months prior the pasta feeding
  • Chronic diseases
  • Surgeries
  • Consumer of whole grain products
  • Dieting
  • Pregnant or lactating

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Control pasta
Volunteers were fed with control pasta, without B-glucans and spores of B. coagulans once a day for 12 weeks.
Complément alimentaire: whole grain pasta
Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.
Expérimental: Probiotic Whole Grain Pasta
Volunteers were fed with probiotic fortified pasta, including B-glucans and spores of B. coagulans once a day for 12 weeks.
Complément alimentaire: whole grain pasta
Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Variation of plasma lipids
Délai: 12 weeks

Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol; Measure of plasma concentrations (µg/mL) of Non Esterified Fatty Acids (NEFA), Esterified Fatty Acids (EFA) and Short Chain Fatty Acids (SCFA).

Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
12 weeks
Variation of fecal microbiota composition
Délai: 12 weeks

By FISH (colony-forming unit, CFU/g).

Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
12 weeks
Variation of antioxidant activity on fecal waters
Délai: 12 weeks

Measure of fecal waters FRAP (µmol/L) and TEAC (µmol/L) concentrations.

Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
12 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Variation of body weight
Délai: 12 weeks
Measure of body weight (kg).
12 weeks
Variation of serum inflammatory marker concentration
Délai: 12 weeks

Measure of serum IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, IFN-γ,TNF-α, PAI-1, Ghrelin, Leptin, Visfatin, Resistin concentrations (pg/mL).

Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.
12 weeks
Variation of blood pressure
Délai: 12 weeks

Measure of blood pressure (mmHg).

Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.
12 weeks
Variation of body circumferences
Délai: 12 weeks

Measure of waist and hip circumferences (mm).

Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.
12 weeks
Variation of urine antioxidant marker
Délai: 12 weeks

Measurement of betaine in urine (mmol/L).

Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.
12 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Parma

Collaborateurs

Universita di Verona

Les enquêteurs

  • Chercheur principal: Nicoletta Pellegrini, Professor, University of Parma

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2014

Achèvement primaire (Réel)

1 septembre 2014

Achèvement de l'étude (Réel)

1 mars 2015

Dates d'inscription aux études

Première soumission

26 juillet 2014

Première soumission répondant aux critères de contrôle qualité

7 septembre 2014

Première publication (Estimation)

10 septembre 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 novembre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 octobre 2018

Dernière vérification

1 octobre 2018

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SFLAB14

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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