Healthy Effects of an Innovative Probiotic Pasta

NCT ID: NCT02236533

Last Updated: 2018-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-03-31

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.

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.

Conditions

OBESITY; INFLAMMATION; DYSLIPIDEMIA; CONSTIPATION

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Control pasta

Volunteers were fed with control pasta, without B-glucans and spores of B. coagulans once a day for 12 weeks.

Group Type: PLACEBO_COMPARATOR

whole grain pasta

Intervention Type: DIETARY_SUPPLEMENT

Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.

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.

Group Type: EXPERIMENTAL

whole grain pasta

Intervention Type: DIETARY_SUPPLEMENT

Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.

Interventions

whole grain pasta

Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universita di Verona

OTHER

Sponsor Role: collaborator

University of Parma

OTHER

Sponsor Role: lead

Responsible Party

Nicoletta Pellegrini, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicoletta Pellegrini, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Parma

Locations

University of Parma - Department of Food Sciences

Parma, PR, Italy

University of Parma

Parma, , Italy

Countries

Italy

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Other Identifiers

SFLAB14

Identifier Type: -

Identifier Source: org_study_id