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| Name | Class |
|---|---|
| Universita di Verona | OTHER |
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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.
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:
In addition, volunteers filled in different questionnaires regarding their dietary habits, the physical activity and the gut healthiness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control pasta | Placebo Comparator | Volunteers were fed with control pasta, without B-glucans and spores of B. coagulans once a day for 12 weeks. |
|
| Probiotic Whole Grain Pasta | Experimental | Volunteers were fed with probiotic fortified pasta, including B-glucans and spores of B. coagulans once a day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| whole grain pasta | Dietary Supplement | Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicoletta Pellegrini, Professor | University of Parma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Parma - Department of Food Sciences | Parma | PR | 43124 | Italy | ||
| University of Parma |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17513398 | Background | Andersson A, Tengblad S, Karlstrom B, Kamal-Eldin A, Landberg R, Basu S, Aman P, Vessby B. Whole-grain foods do not affect insulin sensitivity or markers of lipid peroxidation and inflammation in healthy, moderately overweight subjects. J Nutr. 2007 Jun;137(6):1401-7. doi: 10.1093/jn/137.6.1401. | |
| 15531664 | Background |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007249 | Inflammation |
| D050171 | Dyslipidemias |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| Parma |
| 43124 |
| Italy |
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| 16963350 | Background | Behall KM, Scholfield DJ, Hallfrisch J. Whole-grain diets reduce blood pressure in mildly hypercholesterolemic men and women. J Am Diet Assoc. 2006 Sep;106(9):1445-9. doi: 10.1016/j.jada.2006.06.010. |
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| 31162597 | Derived | Angelino D, Martina A, Rosi A, Veronesi L, Antonini M, Mennella I, Vitaglione P, Grioni S, Brighenti F, Zavaroni I, Fares C, Torriani S, Pellegrini N. Glucose- and Lipid-Related Biomarkers Are Affected in Healthy Obese or Hyperglycemic Adults Consuming a Whole-Grain Pasta Enriched in Prebiotics and Probiotics: A 12-Week Randomized Controlled Trial. J Nutr. 2019 Oct 1;149(10):1714-1723. doi: 10.1093/jn/nxz071. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D012817 | Signs and Symptoms, Digestive |