Postprandial Glycaemia,NCT01222845
Glycaemic, Insulinaemic and Appetite Responses to Two Different Types of Porridge
A study testing Test meal in people with Postprandial Glycaemia, and Postprandial Insulinaemia, run by Northumbria University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the postprandial glycaemic, insulinaemic and appetite responses to porridge made with oats processed differently. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glycaemia,, Postprandial Insulinaemia, Appetite
- What is being tested?
- Test meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Apr 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Aged 18-40 years
Who cannot join
- Food allergies
- Metabolic disorders
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain, Performance and Nutrition Centre, Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
The purpose of this study is to assess the postprandial glycaemic, insulinaemic and appetite responses to porridge made with oats processed differently.
- Conditions
- Postprandial Glycaemia,, Postprandial Insulinaemia, Appetite
- Being tested
- Test meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test mealDrug
Porridge made from rolled, or pinhead oats providing 50 g of carbohydrate
| Study group | Role | What they receive |
|---|---|---|
| Pinhead oat porridge | Experimental | Not described Receives: Drug: Test meal |
| Rolled oat porridge | Experimental | Not described Receives: Drug: Test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Measured: Measured at baseline, 15, 30, 45, 60, 90 and 120 min after ingestion of a test meal
Secondary outcomes (2)
Plasma insulin
Measured: Measured at baseline, 15, 30, 45, 60, 90 and 120 min after ingestion of a test meal
Subjective appetite ratings
Measured by a visual analogue scale (VAS)
Measured: Measured at baseline, 15, 30, 45, 60, 90 and 120 min after ingestion of a test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2011
- Study completionApr 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 Postprandial Glycaemia,Studies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, Northumbria University
- Investigators
- Emma J Stevenson, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222845
- Sponsor's protocol ID
- 32W4
- Status last verified
- May 2012
- First submitted
- 12 Oct 2010
- Last updated
- 2 May 2012
- Results posted
- No
Publications
Gonzalez JT, Stevenson EJ. Postprandial glycemia and appetite sensations in response to porridge made with rolled and pinhead oats. J Am Coll Nutr. 2012 Apr;31(2):111-6. doi: 10.1080/07315724.2012.10720016.
PubMed 22855916
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycaemic, Insulinaemic and Appetite Responses to Two Different Types of Porridge
- ClinicalTrials.gov ID
- NCT01222845
- Acronym / sponsor ID
- 32W4
- Conditions
- Postprandial Glycaemia,, Postprandial Insulinaemia, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Oct 2010 (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 purpose of this study is to assess the postprandial glycaemic, insulinaemic and appetite responses to porridge made with oats processed differently.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pinhead oat porridge | Experimental | Drug: Test meal |
| Rolled oat porridge | Experimental | Drug: Test meal |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- Aged 18-40 years
Key exclusion criteria (2 listed)
- Food allergies
- Metabolic disorders
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 mealPorridge made from rolled, or pinhead oats providing 50 g of carbohydrate | Drug | Pinhead oat porridge, Rolled oat porridge |
Primary outcome
Blood glucose
Time frame: Measured at baseline, 15, 30, 45, 60, 90 and 120 min after ingestion of a test meal
2 secondary outcomes
Plasma insulin
Time frame: Measured at baseline, 15, 30, 45, 60, 90 and 120 min after ingestion of a test meal
Subjective appetite ratings
Time frame: Measured at baseline, 15, 30, 45, 60, 90 and 120 min after ingestion of a test meal
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 2 May 2012.
- Derived from this study: PubMed 22855916Gonzalez JT, Stevenson EJ. Postprandial glycemia and appetite sensations in response to porridge made with rolled and pinhead oats. J Am Coll Nutr. 2012 Apr;31(2):111-6. doi: 10.1080/07315724.2012.10720016.
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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.
Emma J Stevenson, PhD principal investigator
Northumbria 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 Test meal in people with Postprandial Glycaemia, and Postprandial Insulinaemia, run by Northumbria University at 1 site in United Kingdom.
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 2 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 2 May 2012. 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 Kingdom. 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?
Blood glucose (time frame: Measured at baseline, 15, 30, 45, 60, 90 and 120 min after ingestion of a test meal). 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 NCT01222845, 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 2 May 2012.