Blood Glucose ConcentrationNCT01469312
Effect of Pasta on Blood Glucose Response in Normal Subjects
A study testing modified pasta in people with Blood Glucose Concentration and Type 2 Diabetes, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The objective of this study is to determine whether ingestion of modified pasta products (Dreamfields, Miracle Noodles) result in an improvement in blood glucose concentration when compared with a traditional pasta. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose Concentration, Type 2 Diabetes, Metabolic Syndrome
- What is being tested?
- modified pasta
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2011
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal blood glucose concentration
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
About this study
The objective of this study is to determine whether ingestion of modified pasta products (Dreamfields, Miracle Noodles) result in an improvement in blood glucose concentration when compared with a traditional pasta.
Read the detailed description
On one occasion the pasta will be a traditionally available pasta; on another occasion, approximately 1 week later a modified pasta, advertised to contain ~ 5 grams of digestible carbohydrate, or to be low in digestible starch, will be studied.
- Being tested
- modified pasta
- Keywords
- Low Biologically Available Glucose Diet (LoBAG diet), Diabetes, Glycemic Index
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified pastaOther
Also called Dreamfields Pasta, Miracle Noodles
50 grams carbohydrate as a single breakfast meal
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | The control arm consists of the traditional pasta. Receives: Other: modified pasta |
| Modified pasta | Active comparator | Dreamfields, Miracle Noodles Receives: Other: modified pasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Glucose
Blood glucose will be determined by finger stick.
Measured: 0, 30, 60, 90, 120, and 180 minutes after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startApr 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Glucose ConcentrationStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center
- Investigators
- Frank Q Nuttall, M.D., Ph.D., Principal investigator, Minneapolis Veterans Affairs Medical CenterMary C Gannon, Ph.D., Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469312
- Sponsor's protocol ID
- 4231
- Status last verified
- Nov 2011
- First submitted
- 3 Nov 2011
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Nuttall FQ, Schweim K, Hoover H, Gannon MC. Effect of the LoBAG30 diet on blood glucose control in people with type 2 diabetes. Br J Nutr. 2008 Mar;99(3):511-9. doi: 10.1017/S0007114507819155. Epub 2007 Sep 10.
PubMed 17868489
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pasta on Blood Glucose Response in Normal Subjects
- ClinicalTrials.gov ID
- NCT01469312
- Acronym / sponsor ID
- 4231
- Keywords
- Low Biologically Available Glucose Diet (LoBAG diet), Diabetes, Glycemic Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Study start
- Apr 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Nov 2011 (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 objective of this study is to determine whether ingestion of modified pasta products (Dreamfields, Miracle Noodles) result in an improvement in blood glucose concentration when compared with a traditional pasta.
Detailed description
On one occasion the pasta will be a traditionally available pasta; on another occasion, approximately 1 week later a modified pasta, advertised to contain ~ 5 grams of digestible carbohydrate, or to be low in digestible starch, will be studied.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: modified pastaThe control arm consists of the traditional pasta. |
| Modified pasta | Active comparator | Other: modified pastaDreamfields, Miracle Noodles |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal blood glucose concentration
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| modified pastaAlso: Dreamfields Pasta, Miracle Noodles50 grams carbohydrate as a single breakfast meal | Other | Control, Modified pasta |
Primary outcome
Change in Blood Glucose
Time frame: 0, 30, 60, 90, 120, and 180 minutes after ingestion
Blood glucose will be determined by finger stick.
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 11 Nov 2011.
- Background: PubMed 17868489Nuttall FQ, Schweim K, Hoover H, Gannon MC. Effect of the LoBAG30 diet on blood glucose control in people with type 2 diabetes. Br J Nutr. 2008 Mar;99(3):511-9. doi: 10.1017/S0007114507819155. Epub 2007 Sep 10.
Related trials for Blood Glucose Concentration
Not yet recruiting
A Clinical Trial to Investigate the Acute Effect of Bragg Apple Cider Vinegar Supplement on Blood Glucose Control in a Healthy Adult Population
Postprandial Glucose, Blood Glucose Concentration
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.
Frank Q Nuttall, M.D., Ph.D. principal investigator
Minneapolis Veterans Affairs Medical Center
Mary C Gannon, Ph.D. principal investigator
Minneapolis Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified pasta in people with Blood Glucose Concentration and Type 2 Diabetes, run by Minneapolis Veterans Affairs Medical Center 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 1 inclusion and 0 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 11 Nov 2011. 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. Some participants in this study may receive a placebo. 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?
Change in Blood Glucose (time frame: 0, 30, 60, 90, 120, and 180 minutes after ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01469312, which also lists 1 linked publication.
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 11 Nov 2011.