HyperglycemiaNCT00687960
Effect of Resistant Starch Type 4 on Glycemia and Insulin Sensitivity in Young Adults
A study testing Resistant starch type 4 - raw, Resistant Starch Type 4 - Cooked and Dextrose in people with Hyperglycemia, run by Kansas State University at 1 site in United States.
Trial summary
This study tested the effects of resistant starch type 4 on blood sugar and hunger in young adults with Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Resistant starch type 4 - raw, Resistant Starch Type 4 - Cooked and Dextrose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2007
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently Healthy (not diagnosed with disease)
- Young Adults (18-35)
Who cannot join
- Diagnosed with diabetes or other metabolic disorders
- Allergies to Wheat
- Non-smokers
Trial locations and contacts
1 site in 1 country.
About this study
This study tested the effects of resistant starch type 4 on blood sugar and hunger in young adults with Type 2 diabetes.
Read the detailed description
To measure the blood glucose response, after an overnight fast, blood samples were collected before eating and at 15, 30, 45, 60, 90, and 120 minutes after each each bar. The incremental area under the curve was used to calculate the glycemic index and insulin sensitivity via minimal model.
- Conditions
- Hyperglycemia
- Being tested
- Resistant starch type 4 - raw, Resistant Starch Type 4 - Cooked, Dextrose, Puffed Wheat
- Keywords
- Diabetes, Diet, Fiber, Age
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant starch type 4 - rawDietary supplement
Dose: 80g bar containing Resistant Starch Type 4 - raw
Resistant Starch Type 4 - CookedDietary supplement
Dose: 80g bar containing Resistant Starch Type 4 - cooked
DextroseDietary supplement
Dose: 7 oz of oral glucose tolerance beverage
Puffed WheatDietary supplement
Dose: 80g bar containing puffed wheat cereal
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Resistant Starch Type 4-Raw Receives: Dietary Supplement: Resistant starch type 4 - raw |
| 2 | Experimental | Resistant Starch Type 4-cooked Receives: Dietary Supplement: Resistant Starch Type 4 - Cooked |
| 3 | Active comparator | Puffed wheat Receives: Dietary Supplement: Puffed Wheat |
| 4 | Placebo comparator | Dextrose Receives: Dietary Supplement: Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Prandial Metabolism
Measured: Early morning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startNov 2006
- Primary completionMay 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Collaborators
- MGP Ingredients, Inc.
- Investigators
- Mark Haub, Ph.D., Principal investigator, Department of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687960
- Sponsor's protocol ID
- KSU-HML-RSt2
- Status last verified
- May 2008
- First submitted
- 22 May 2008
- Last updated
- 2 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistant Starch Type 4 on Glycemia and Insulin Sensitivity in Young Adults
- ClinicalTrials.gov ID
- NCT00687960
- Acronym / sponsor ID
- KSU-HML-RSt2
- Conditions
- Hyperglycemia
- Keywords
- Diabetes, Diet, Fiber, Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Collaborators
- MGP Ingredients, Inc.
- Study start
- Nov 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 2 Jun 2008 (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.
This study tested the effects of resistant starch type 4 on blood sugar and hunger in young adults with Type 2 diabetes.
Detailed description
To measure the blood glucose response, after an overnight fast, blood samples were collected before eating and at 15, 30, 45, 60, 90, and 120 minutes after each each bar. The incremental area under the curve was used to calculate the glycemic index and insulin sensitivity via minimal model.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Resistant starch type 4 - rawResistant Starch Type 4-Raw |
| 2 | Experimental | Dietary Supplement: Resistant Starch Type 4 - CookedResistant Starch Type 4-cooked |
| 3 | Active comparator | Dietary Supplement: Puffed WheatPuffed wheat |
| 4 | Placebo comparator | Dietary Supplement: DextroseDextrose |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Apparently Healthy (not diagnosed with disease)
- Young Adults (18-35)
Key exclusion criteria (3 listed)
- Diagnosed with diabetes or other metabolic disorders
- Allergies to Wheat
- Non-smokers
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 |
|---|---|---|
| Resistant starch type 4 - rawDose: 80g bar containing Resistant Starch Type 4 - raw | Dietary supplement | 1 |
| Resistant Starch Type 4 - CookedDose: 80g bar containing Resistant Starch Type 4 - cooked | Dietary supplement | 2 |
| DextroseDose: 7 oz of oral glucose tolerance beverage | Dietary supplement | 4 |
| Puffed WheatDose: 80g bar containing puffed wheat cereal | Dietary supplement | 3 |
Primary outcome
Post-Prandial Metabolism
Time frame: Early morning
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 Jun 2008.
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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.
Mark Haub, Ph.D. principal investigator
Department of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant starch type 4 - raw, Resistant Starch Type 4 - Cooked and Dextrose in people with Hyperglycemia, run by Kansas State University 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 2 inclusion and 3 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 Jun 2008. 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?
Post-Prandial Metabolism (time frame: Early morning). 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 2 Jun 2008.