Healthy Effects of an Innovative Probiotic Pasta (SFLABPASTA)

October 30, 2018 updated by: Nicoletta Pellegrini, PhD, University of Parma
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43124
        • University of Parma
    • PR
      • Parma, PR, Italy, 43124
        • University of Parma - Department of Food Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control pasta
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
Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.
Experimental: 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.
Dietary supplement: whole grain pasta
Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of plasma lipids
Time Frame: 12 weeks

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
Time Frame: 12 weeks

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
Time Frame: 12 weeks

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
Time Frame: 12 weeks
Measure of body weight (kg).
12 weeks
Variation of serum inflammatory marker concentration
Time Frame: 12 weeks

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
Time Frame: 12 weeks

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
Time Frame: 12 weeks

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
Time Frame: 12 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Parma

Collaborators

Universita di Verona

Investigators

  • Principal Investigator: Nicoletta Pellegrini, Professor, University of Parma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 26, 2014

First Submitted That Met QC Criteria

September 7, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Actual)

November 1, 2018

Last Update Submitted That Met QC Criteria

October 30, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFLAB14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on OBESITY

Clinical Trials on whole grain pasta

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe