Healthy Effects of an Innovative Probiotic Pasta

Study Overview
=================
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.

Official Title
-----------------
Healthy Effects of an Innovative Probiotic Pasta

Conditions
-----------------
OBESITY, INFLAMMATION, DYSLIPIDEMIA, CONSTIPATION

Intervention / Treatment
-----------------
* Dietary Supplement: whole grain pasta


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control pasta<br>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<br>* Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.<br>|
| Experimental: Probiotic Whole Grain Pasta<br>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<br>* Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of plasma lipids | 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 | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of body weight | Measure of body weight (kg). | 12 weeks | 
| Variation of serum inflammatory marker concentration | 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 | 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 | 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 | 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 |