Healthy Effects of an Innovative Probiotic Pasta (SFLABPASTA)

University of Parma

Status: Completed

Conditions: CONSTIPATION; OBESITY; DYSLIPIDEMIA; INFLAMMATION

Treatments: Dietary Supplement: whole grain pasta

Study type: Interventional

Funder types: Other

Identifiers

NCT02236533

SFLAB14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Control pasta

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: whole grain pasta

Probiotic Whole Grain Pasta

Experimental group

Description:

Volunteers were fed with probiotic fortified pasta, including B-glucans and spores of B. coagulans once a day for 12 weeks.

Treatment:

Dietary Supplement: whole grain pasta