Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT02236533
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2014-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Healthy Effects of an Innovative Probiotic Pasta
Sponsor:
University of Parma
Organization:
Study Overview
Official Title:
Healthy Effects of an Innovative Probiotic Pasta
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SFLABPASTA
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: