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Completed

NCT Number: NCT02236533

Healthy Effects of an Innovative Probiotic Pasta

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.

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Key information

Conditions

Obesity Body Weight Constipation Dyslipidemia Dyslipidemias Inflammation Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

whole grain pasta

Dietary Supplement

Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Variation of body weight

    Time frame: 12 weeks

    Measure of body weight (kg).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Collaborators

  • Universita di Verona

Registry information

Acronym: SFLABPASTA

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 10, 2014
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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