Healthy VolunteersPROPASTANCT02842606
Metabolic Response to the Acute Consumption of Fiber-enriched Pasta
A study testing Test meal in people with Healthy Volunteers, run by Federico II University.
Trial summary
Cardio-metabolic diseases are a leading cause of mortality worldwide. Over the years, therefore, there have been considerable efforts to identify strategies for prevention and management of risk factors. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Test meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jul 2016
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18-29 kg / m2
- Good Health status
Who cannot join
- Diabetes
- Cardiovascular events (IMA or stroke) severe heart disease
- Kidney or liver failure
- Anemia and any other chronic disease
About this study
Official title: Effects of the Consumption of Fiber-enriched Pasta on Glucose and Lipid Metabolism and Satiety
Cardio-metabolic diseases are a leading cause of mortality worldwide. Over the years, therefore, there have been considerable efforts to identify strategies for prevention and management of risk factors. The diet, with its pleiotropic effects, is one of the most effective approaches to reduce the cardio-metabolic risk. In this context, the dietary fibers have been extensively studied and the available evidence supports the beneficial effects of its consumption. However, worldwide the average fiber consumption is still less than the recommended daily dose. For this reason, the availability of functional foods, such as additional sources of fiber in the diet, may facilitate the attainment of fiber recommended.
- Conditions
- Healthy Volunteers
- Being tested
- Test meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test mealOther
Also called Acute test meal
The two test meals are designed to have the same energy and macronutrient composition. They differ only in the carbohydrate source: fiber-enriched pasta or control pasta. Blood samples are taken at fasting and every 30 minutes over 4 hours. Fasting and postprandial intestinal fermentation is evaluated by breath test.
| Study group | Role | What they receive |
|---|---|---|
| Fiber-enriched pasta | Experimental | The participants consume whole wheat pasta with added fiber (fiber 12 g fiber/100 g). Receives: Other: Test meal |
| Control pasta | Active comparator | The participants consume pasta made from durum wheat semolina (fiber 2.7g/100g). Receives: Other: Test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose and lipid response
Evaluated by enzymatic colorimetric methods
Measured: 4 hours
Secondary outcomes (3)
Insulin response
Evaluated by ELISA
Measured: 4 hours
Hormone response (GLP-1, GIP, PYY and Ghrelin)
Evaluated by ELISA
Measured: 4 hours
Energy intake in the subsequent meal.
Evaluated by food record
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rivellese angela, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842606
- Sponsor's protocol ID
- 166/14
- Acronym
- PROPASTA
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2016
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Consumption of Fiber-enriched Pasta on Glucose and Lipid Metabolism and Satiety
- ClinicalTrials.gov ID
- NCT02842606
- Acronym / sponsor ID
- PROPASTA / 166/14
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 25 Jul 2016 (estimated)
- 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.
Cardio-metabolic diseases are a leading cause of mortality worldwide. Over the years, therefore, there have been considerable efforts to identify strategies for prevention and management of risk factors. The diet, with its pleiotropic effects, is one of the most effective approaches to reduce the cardio-metabolic risk. In this context, the dietary fibers have been extensively studied and the available evidence supports the beneficial effects of its consumption. However, worldwide the average fiber consumption is still less than the recommended daily dose. For this reason, the availability of functional foods, such as additional sources of fiber in the diet, may facilitate the attainment of fiber recommended.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber-enriched pasta | Experimental | Other: Test mealThe participants consume whole wheat pasta with added fiber (fiber 12 g fiber/100 g). |
| Control pasta | Active comparator | Other: Test mealThe participants consume pasta made from durum wheat semolina (fiber 2.7g/100g). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 18-29 kg / m2
- Good Health status
Key exclusion criteria (4 listed)
- Diabetes
- Cardiovascular events (IMA or stroke) severe heart disease
- Kidney or liver failure
- Anemia and any other chronic disease
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 |
|---|---|---|
| Test mealAlso: Acute test mealThe two test meals are designed to have the same energy and macronutrient composition. They differ only in the carbohydrate source: fiber-enriched pasta or control pasta. Blood samples are taken at fasting and every 30 minutes over 4 hours. Fasting and postprandial intestinal fermentation is evaluated by breath test. | Other | Control pasta, Fiber-enriched pasta |
Primary outcome
Glucose and lipid response
Time frame: 4 hours
Evaluated by enzymatic colorimetric methods
3 secondary outcomes
Insulin response
Time frame: 4 hours
Hormone response (GLP-1, GIP, PYY and Ghrelin)
Time frame: 4 hours
Energy intake in the subsequent meal.
Time frame: 4 hours
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 10 Aug 2017.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Test meal in people with Healthy Volunteers, run by Federico II University.
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 2 inclusion and 4 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 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Glucose and lipid response (time frame: 4 hours). 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 10 Aug 2017.