Overweight and ObesityProPasNCT04962633
Dietary Intervention With Probiotic Pasta and Evaluation of the Effects on Metabolic and Inflammatory Status
A study testing Probiotic Pasta in people with Overweight and Obesity, run by Federico II University at 1 site in Italy.
Trial summary
This study aims to investigate the effects of daily consumption for 4 weeks of a probiotic durum wheat pasta vs a conventional durum wheat pasta without probiotics on fasting metabolic parameters and inflammatory status, on gut permeability and functionality, on daily energy intakes, appetite feelings, body weight… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Probiotic Pasta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects;
- men and women;
- age 18-65 years;
- 25 kg/m2 ≤ BMI ≤ 35 kg/m2;
- habitual daily pasta consumption (≥ 1 portion/day);
- habitual diet characterized by absence of any food supplements and alternative medication, probiotics and prebiotics, whole grain and/or fiber enriched foods;
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- intake of fruit/vegetables < 3 servings/day;
- low level of physical activity (< 500 metabolic equivalent min/week);
- signed written informed consent.
Who cannot join
- food allergies and intolerances and celiac disease;
- gastrointestinal diseases;
- relevant diseases;
- pregnant or breastfeeding;
- previous abdominal surgery;
- hypertriglyceridemia (Triglycerides > 200 mg/dL);
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- hypercholesterolemia (Total cholesterol > 200 mg/dL);
- hyperglycaemia (glycaemia ≥ 110 mg/dL);
- hypertension (arterial blood pressure ≥140/90 mm Hg);
- weight loss ≥ 3 kg within 2 months before the study;
- antibiotics treatment within 3 months before the study;
- any medication (different from antibiotics) at the enrollment and within 2 months before the study;
- habitual diet characterized by high fruit and vegetables intakes (>3 portion/die);
- high level of physical activity;
- Alcohol consumption ≥ 3 alcohol units per day;
- simultaneous participation in other trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Intervention With Probiotic Pasta and Evaluation of the Effects on Metabolic and Inflammatory Status in Overweight and Obese Subjects
This study aims to investigate the effects of daily consumption for 4 weeks of a probiotic durum wheat pasta vs a conventional durum wheat pasta without probiotics on fasting metabolic parameters and inflammatory status, on gut permeability and functionality, on daily energy intakes, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences, blood pressure, body composition and wellbeing status in overweight and obese subjects.
Read the detailed description
Growing evidence highlights the role of the individual diet and gut microbiome in modulating human metabolism, inflammatory status and cardiovascular risk.
This scenario supports nutritional approaches targeted to modify gut microbiota composition to trigger health benefits and the interest to develop novel functional foods enriched with probiotics. Most of commercial probiotic foods are in the category of dairy products and contain Lactobacillus strains. Besides that, Bacillus spp. along with the ability to form spores show probiotic attributes by exhibiting pathogen exclusion and antioxidant, antimicrobial and immune-modulatory abilities. Furthermore, they possess a stronger viability and stability to withstand high temperature processes, such as baking and boiling, than other probiotic bacteria thus representing an ideal choice for the development of functional cereal-based products.
In particular, Bacillus clausii UBBC07 exhibits probiotic properties by alleviating the severity and symptoms of acute diarrhoea in adults and children and show a high stability over a wide range of temperatures with potential applications in a variety of formulations and foods. The health benefits of B. clausii UBBC07 in overweight and obese subjects is unexplored.
This study aims to investigate the effects of consumption for 4 weeks of a probiotic durum wheat pasta enriched with spores of B. clausii UBBC07 vs a conventional durum wheat pasta (control) on metabolic and inflammatory status, on gut permeability and functionality, on daily energy intakes, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences, blood pressure, body composition and wellbeing status in overweight and obese subjects.
- Conditions
- Overweight and Obesity
- Being tested
- Probiotic Pasta, Control Pasta
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic PastaOther
Subjects will consume for 4 weeks 80 g per day of probiotic durum wheat pasta. All subjects will be requested not to change the other daily dietary habits and their physical activity levels during the 4 week intervention period.
Control PastaOther
Subjects will consume for 4 weeks 80 g per day of conventional durum wheat pasta without probiotics. All subjects will be requested not to change the other daily dietary habits and their physical activity levels during the 4 week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Pasta Group | Experimental | Subjects in the Probiotic Pasta group will consume 80 g per day of a probiotic pasta for 4 weeks Receives: Other: Probiotic Pasta |
| Control Pasta Group | Active comparator | Control Pasta Subjects in the Control Pasta group will consume 80 g per day of conventional pasta for 4 weeks. Receives: Other: Control Pasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fasting inflammatory blood markers
Measure of plasma C-reactive protein (mmol/L)
Measured: 1 months
Changes in fasting plasma lipids
Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides
Measured: 1 months
Changes in fasting plasma glucose
Measure of plasma glucose concentrations (mg/dL)
Measured: 1 months
Secondary outcomes (25)
Changes in small intestine permeability
Measure of lactulose and mannitol excreted in urines collected in the 0-5 hours time interval after an oral challenge with 5 g lactulose, 2 g mannitol and 2 g sucralose dissolved in 100 mL of water. The amounts of lactulose and mannitol excreted will be expressed in milligrams, and their ratio (lactulose/mannitol) will be calculated and used as marker of small intestine permeability
Measured: 1 month
Changes in colonic permeability
Measure of sucralose excreted in urines collected over 24 hours after an oral challenge with 5 g lactulose, 2 g mannitol and 2 g sucralose dissolved in 100 mL of water. The amount of sucralose excreted will be expressed in milligrams and will be used as marker of colonic permeability
Measured: 1 month
Changes in stool consistency
Measure of consistency of feces by mean of King's stool chart filled out by subjects. The chart comprises four categories of stool consistency: hard and formed, soft and formed, loose and unformed, liquid.
Measured: 1 month
Changes in stool weight
Measure of stool weight by mean of King's stool chart filled out by subjects. The chart comprises three categories of stool weight : <100 g, 100-200 g, >200 g.
Measured: 1 month
Changes in stool frequency
Measure of frequency of feces by mean of King's stool chart filled out by subjects. Fecal frequency is incorporated by recording the code of each feces passed over a 24 hour period.
Measured: 1 month
Changes in gastrointestinal functionality
Calculation of daily fecal score from summation of all scores for stool consistency, weight and frequency obtained from King's stool chart filled out by subjects. Scores are weighted such that an increase in fecal frequency alone results in a higher score than a change in fecal consistency alone, which in turn results in a higher score than an increase in fecal weight alone. Diarrhea is classified by a daily fecal score of 15 or more.
Measured: 1 month
Changes in faecal microbiome
The composition of faecal microbiome will be determined by high throughput sequencing of the 16S ribosomal ribonucleic acid (rRNA) gene. The massive number of sequences obtained will be analyzed by using state of the art bioinformatics tools and the presence and relative abundance of the microbial species occurring in each sample will be determined.
Measured: 1 month
Variation of plasma glucagon like peptide-1 concentration
Measure of plasma glucagon like peptide-1 concentrations (mg/dL)
Measured: 1 month
Variation of plasma gastric inhibitory polypeptide hormone concentration
Measure of plasma gastric inhibitory polypeptide concentrations (mg/dL)
Measured: 1 month
Variation of plasma Glucagon hormone concentration
Measure of plasma Glucagon concentrations (mg/dL)
Measured: 1 month
Variation of plasma Ghrelin hormone concentration
Measure of plasma Ghrelin concentrations (mg/dL)
Measured: 1 month
Variation of plasma Insulin hormone concentration
Measure of plasma Insulin concentrations (mg/dL)
Measured: 1 month
Variation of plasma endocannabinoids and N-acyl-ethanolamines concentration
Measure of plasma endocannabinoids and N-acyl-ethanolamines concentrations (mg/dL)
Measured: 1 month
Variation of serum dipeptidyl-dipeptidase-IV activity
Measure of activity of dipeptidyl-dipeptidase-IV activity (U/L)
Measured: 1 month
Changes in body weight
Measure of body weight in fasting subjects
Measured: 1 month
Changes in body mass index
Calculation of body mass index by the formula weight in kilograms divided by height in meters squared.
Measured: 1 month
Changes in waist circumference
Measure of waist circumference at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest, with the tape parallel to the floor.
Measured: 1 month
Changes in hip circumference
Measure of hip circumference around the widest portion of the buttocks, with the tape parallel to the floor.
Measured: 1 month
Changes in blood pressure
Measure of systolic pressure and diastolic pressure in millimetres of mercury (mmHg) by using a digital sphygmomanometer
Measured: 1 month
Changes in body composition
Body composition is determined by conventional bioelectrical impedance analysis with a single-frequency 50 kilohertz (kHz) bioelectrical impedance analyzer in the postabsorptive state (fasting subjects) and after being in the supine position for 20 min. Body composition data will be calculated from bioelectrical measurements and anthropometric data by using validated predictive equations.
Measured: 1 month
Variation of daily energy intakes
Calculation of total daily energy intakes based on 7 days food records
Measured: 1 month
Variation of hunger sensation scores
Measures of hunger sensation over the day reported by subjects by using hunger Visual Analogue Scales (VAS) 0-10 centimeters. Changes in these scores may reflect potential effects of dietary intervention in modulating hunger.
Measured: 1 month
Variation of fullness sensation scores
Measure of fullness sensation over the day reported by subjects by using fullness Visual Analogue Scales (VAS) 0-10 centimeters. Changes in these scores may reflect potential effects of dietary intervention in modulating fullness.
Measured: 1 month
Variation of satiety sensation scores
Measure of satiety sensation over the day reported by subjects by using satiety Visual Analogue Scales (VAS) 0-10 centimeters. Changes in these scores may reflect potential effects of dietary intervention in modulating satiety.
Measured: 1 month
Variation of wellbeing status
Estimate of wellbeing status by mean of quality of life (QoL) questionnaire, which is based on Short Form-12 Health Survey (SF-12), a self-report form of subjective health. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Jan 2022
- Primary completion23 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paola Vitaglione, Federico II University
- Investigators
- Paola Vitaglione, Professor, Study director, Department of Agricultural Sciences, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962633
- Sponsor's protocol ID
- ProPas
- Acronym
- ProPas
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the IPD related to the results reported in the published paper with researchers who request it to the principal investigator (PI) or the corresponding authors.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention With Probiotic Pasta and Evaluation of the Effects on Metabolic and Inflammatory Status in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT04962633
- Acronym / sponsor ID
- ProPas / ProPas
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effects of daily consumption for 4 weeks of a probiotic durum wheat pasta vs a conventional durum wheat pasta without probiotics on fasting metabolic parameters and inflammatory status, on gut permeability and functionality, on daily energy intakes, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences, blood pressure, body composition and wellbeing status in overweight and obese subjects.
Detailed description
Growing evidence highlights the role of the individual diet and gut microbiome in modulating human metabolism, inflammatory status and cardiovascular risk.
This scenario supports nutritional approaches targeted to modify gut microbiota composition to trigger health benefits and the interest to develop novel functional foods enriched with probiotics. Most of commercial probiotic foods are in the category of dairy products and contain Lactobacillus strains. Besides that, Bacillus spp. along with the ability to form spores show probiotic attributes by exhibiting pathogen exclusion and antioxidant, antimicrobial and immune-modulatory abilities. Furthermore, they possess a stronger viability and stability to withstand high temperature processes, such as baking and boiling, than other probiotic bacteria thus representing an ideal choice for the development of functional cereal-based products.
In particular, Bacillus clausii UBBC07 exhibits probiotic properties by alleviating the severity and symptoms of acute diarrhoea in adults and children and show a high stability over a wide range of temperatures with potential applications in a variety of formulations and foods. The health benefits of B. clausii UBBC07 in overweight and obese subjects is unexplored.
This study aims to investigate the effects of consumption for 4 weeks of a probiotic durum wheat pasta enriched with spores of B. clausii UBBC07 vs a conventional durum wheat pasta (control) on metabolic and inflammatory status, on gut permeability and functionality, on daily energy intakes, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences, blood pressure, body composition and wellbeing status in overweight and obese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Pasta Group | Experimental | Other: Probiotic PastaSubjects in the Probiotic Pasta group will consume 80 g per day of a probiotic pasta for 4 weeks |
| Control Pasta Group | Active comparator | Other: Control PastaControl Pasta Subjects in the Control Pasta group will consume 80 g per day of conventional pasta for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- healthy subjects;
- men and women;
- age 18-65 years;
- 25 kg/m2 ≤ BMI ≤ 35 kg/m2;
- habitual daily pasta consumption (≥ 1 portion/day);
Key exclusion criteria (16 listed)
- food allergies and intolerances and celiac disease;
- gastrointestinal diseases;
- relevant diseases;
- pregnant or breastfeeding;
- previous abdominal surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic PastaSubjects will consume for 4 weeks 80 g per day of probiotic durum wheat pasta. All subjects will be requested not to change the other daily dietary habits and their physical activity levels during the 4 week intervention period. | Other | Probiotic Pasta Group |
| Control PastaSubjects will consume for 4 weeks 80 g per day of conventional durum wheat pasta without probiotics. All subjects will be requested not to change the other daily dietary habits and their physical activity levels during the 4 week intervention period. | Other | Control Pasta Group |
Primary outcome
Changes in fasting inflammatory blood markers
Time frame: 1 months
Measure of plasma C-reactive protein (mmol/L)
Changes in fasting plasma lipids
Time frame: 1 months
Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides
Changes in fasting plasma glucose
Time frame: 1 months
Measure of plasma glucose concentrations (mg/dL)
25 secondary outcomes
Changes in small intestine permeability
Time frame: 1 month
Changes in colonic permeability
Time frame: 1 month
Changes in stool consistency
Time frame: 1 month
Changes in stool weight
Time frame: 1 month
Changes in stool frequency
Time frame: 1 month
Changes in gastrointestinal functionality
Time frame: 1 month
Changes in faecal microbiome
Time frame: 1 month
Variation of plasma glucagon like peptide-1 concentration
Time frame: 1 month
Variation of plasma gastric inhibitory polypeptide hormone concentration
Time frame: 1 month
Variation of plasma Glucagon hormone concentration
Time frame: 1 month
Variation of plasma Ghrelin hormone concentration
Time frame: 1 month
Variation of plasma Insulin hormone concentration
Time frame: 1 month
Variation of plasma endocannabinoids and N-acyl-ethanolamines concentration
Time frame: 1 month
Variation of serum dipeptidyl-dipeptidase-IV activity
Time frame: 1 month
Changes in body weight
Time frame: 1 month
Changes in body mass index
Time frame: 1 month
Changes in waist circumference
Time frame: 1 month
Changes in hip circumference
Time frame: 1 month
Changes in blood pressure
Time frame: 1 month
Changes in body composition
Time frame: 1 month
Variation of daily energy intakes
Time frame: 1 month
Variation of hunger sensation scores
Time frame: 1 month
Variation of fullness sensation scores
Time frame: 1 month
Variation of satiety sensation scores
Time frame: 1 month
Variation of wellbeing status
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. We plan to share the IPD related to the results reported in the published paper with researchers who request it to the principal investigator (PI) or the corresponding authors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Vitaglione, Professor study director
Department of Agricultural Sciences, Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Pasta in people with Overweight and Obesity, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fasting inflammatory blood markers (time frame: 1 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.