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Healthy Effects of an Innovative Probiotic Pasta (SFLABPASTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02236533
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Universita di Verona
Information provided by (Responsible Party):
Nicoletta Pellegrini, PhD, University of Parma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
OBESITY INFLAMMATION DYSLIPIDEMIA CONSTIPATION Dietary Supplement: whole grain pasta Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Healthy Effects of an Innovative Probiotic Pasta
Study Start Date : March 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Placebo Comparator: Control pasta
Volunteers were fed with control pasta, without B-glucans and spores of B. coagulans once a day for 12 weeks.
Dietary Supplement: whole grain pasta
Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.

Experimental: 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.
Dietary Supplement: whole grain pasta
Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.




Primary Outcome Measures :
  1. Variation of plasma lipids [ Time Frame: 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.


  2. Variation of fecal microbiota composition [ Time Frame: 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.


  3. Variation of antioxidant activity on fecal waters [ Time Frame: 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.



Secondary Outcome Measures :
  1. Variation of body weight [ Time Frame: 12 weeks ]
    Measure of body weight (kg).

  2. Variation of serum inflammatory marker concentration [ Time Frame: 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.


  3. Variation of blood pressure [ Time Frame: 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.


  4. Variation of body circumferences [ Time Frame: 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.


  5. Variation of urine antioxidant marker [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236533


Locations
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Italy
University of Parma - Department of Food Sciences
Parma, PR, Italy, 43124
University of Parma
Parma, Italy, 43124
Sponsors and Collaborators
University of Parma
Universita di Verona
Investigators
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Principal Investigator: Nicoletta Pellegrini, Professor University of Parma
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nicoletta Pellegrini, PhD, Associate Professor, University of Parma
ClinicalTrials.gov Identifier: NCT02236533    
Other Study ID Numbers: SFLAB14
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Dyslipidemias
Inflammation
Constipation
Pathologic Processes
Signs and Symptoms, Digestive
Lipid Metabolism Disorders
Metabolic Diseases