Food SelectionNCT01792596
Satiety Effects of Protein and Fiber Added to Pasta
A study testing Pasta with protein, Pasta with Fiber and Pasta in people with Food Selection, run by University of Minnesota at 1 site in United States.
Trial summary
The combination of fiber and protein added to pasta will enhance satiety. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Selection
- What is being tested?
- Pasta with protein, Pasta with Fiber and Pasta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jun 2013
- 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
- nonsmoking
- body mass index from 19 - 29
Who cannot join
- Antibiotic use
- any disease
- weight loss
- food allergies
- high fiber intake
- restrained eater
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Food Science and Nutrition
Saint Paul, Minnesota, 55108
About this study
The combination of fiber and protein added to pasta will enhance satiety.
Read the detailed description
Subjects will consume 3 different pasta lunches and satiety will be measured by visual analogue scales. They will consume an ad lib snack after 3 hours and food intake will be measured.
- Conditions
- Food Selection
- Being tested
- Pasta with protein, Pasta with Fiber, Pasta
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasta with proteinOther
Pasta with Protein
Pasta with FiberOther
Pasta with Fiber
PastaOther
Pasta
| Study group | Role | What they receive |
|---|---|---|
| pasta | Other | 1. Plain pasta Receives: Other: Pasta |
| pasta with protein | Other | Pasta with protein Receives: Other: Pasta with protein |
| pasta with fiber | Other | Pasta with Fiber Receives: Other: Pasta with Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
satiety
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SelectionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne Slavin, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792596
- Sponsor's protocol ID
- 1212E25704
- Status last verified
- Jan 2014
- First submitted
- 22 Jan 2013
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satiety Effects of Protein and Fiber Added to Pasta
- ClinicalTrials.gov ID
- NCT01792596
- Acronym / sponsor ID
- 1212E25704
- Conditions
- Food Selection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Feb 2013 (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.
The combination of fiber and protein added to pasta will enhance satiety.
Detailed description
Subjects will consume 3 different pasta lunches and satiety will be measured by visual analogue scales. They will consume an ad lib snack after 3 hours and food intake will be measured.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pasta | Other | Other: Pasta1. Plain pasta |
| pasta with protein | Other | Other: Pasta with proteinPasta with protein |
| pasta with fiber | Other | Other: Pasta with FiberPasta with Fiber |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy
- nonsmoking
- body mass index from 19 - 29
Key exclusion criteria (6 listed)
- Antibiotic use
- any disease
- weight loss
- food allergies
- high fiber intake
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 |
|---|---|---|
| Pasta with proteinPasta with Protein | Other | pasta with protein |
| Pasta with FiberPasta with Fiber | Other | pasta with fiber |
| PastaPasta | Other | pasta |
Primary outcome
satiety
Time frame: 180 minutes
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 7 Jan 2014.
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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.
Joanne Slavin, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pasta with protein, Pasta with Fiber and Pasta in people with Food Selection, run by University of Minnesota at 1 site in United States.
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 3 inclusion and 6 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 7 Jan 2014. 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 United States. 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?
satiety (time frame: 180 minutes). 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 7 Jan 2014.