HyperglycemiaNCT00691249
Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes
A study testing Resistant Starch Type 4-Raw, Resistant Starch Type 4-Cooked and Shredded Wheat in people with Hyperglycemia, run by Kansas State University at 1 site in United States.
Trial summary
This study will test the effects of resistant starch type 4 on blood sugar and hunger in adults with Type 2 diabetes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Resistant Starch Type 4-Raw, Resistant Starch Type 4-Cooked and Shredded Wheat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 2 Diabetics
Who cannot join
- Diagnosed with other metabolic disorders
- Allergies to wheat
- Non-smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
Kansas State Univerity: Department of Human Nutrition
Manhattan, Kansas, 66506
About this study
This study will test the effects of resistant starch type 4 on blood sugar and hunger in adults with Type 2 diabetes.
Read the detailed description
To measure the blood glucose response, after an overnight fast, blood samples will be collected before eating and 15, 30, 45, 60, 90, and 120 minutes after eating each bar. The incremental area under the curve was used to calculate glycemic index. The investigators will also measure the second meal effect by measuring the metabolic response (glucose, insulin, and gut hormones) after a standardized lunch two hours following the first assessment.
- Conditions
- Hyperglycemia
- Being tested
- Resistant Starch Type 4-Raw, Resistant Starch Type 4-Cooked, Shredded Wheat
- Keywords
- Diabetes, Diet, Fiber
- 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
Low Dose- 70g bar
Resistant Starch Type 4-RawDietary supplement
High Dose- 100g bar
Resistant Starch Type 4-CookedDietary supplement
Low Dose- 70g bar
Resistant Starch Type 4-CookedDietary supplement
High dose: 100g bar
Shredded WheatDietary supplement
70g bar
| 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-Raw Receives: Dietary Supplement: Resistant Starch Type 4-Raw |
| 3 | Experimental | Resistant starch type 4-Cooked Receives: Dietary Supplement: Resistant Starch Type 4-Cooked |
| 4 | Experimental | Resistant starch type 4-Cooked Receives: Dietary Supplement: Resistant Starch Type 4-Cooked |
| 5 | Placebo comparator | Shredded wheat Receives: Dietary Supplement: Shredded Wheat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Prandial metabolism
Measured: Acute -- fasting, 15, 30, 45, 60, 90 and 120 minutes post-ingestion
Secondary outcomes (1)
Satiety
Measured: Early morning - Midafternoon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionJun 2009
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
- 10 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
- NCT00691249
- Sponsor's protocol ID
- KSU-HML-RSt3
- Status last verified
- May 2008
- First submitted
- 22 May 2008
- Last updated
- 2 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00691249
- Acronym / sponsor ID
- KSU-HML-RSt3
- Conditions
- Hyperglycemia
- Keywords
- Diabetes, Diet, Fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Collaborators
- MGP Ingredients, Inc.
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 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 will test the effects of resistant starch type 4 on blood sugar and hunger in adults with Type 2 diabetes.
Detailed description
To measure the blood glucose response, after an overnight fast, blood samples will be collected before eating and 15, 30, 45, 60, 90, and 120 minutes after eating each bar. The incremental area under the curve was used to calculate glycemic index. The investigators will also measure the second meal effect by measuring the metabolic response (glucose, insulin, and gut hormones) after a standardized lunch two hours following the first assessment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Resistant Starch Type 4-RawResistant starch type 4-Raw |
| 2 | Experimental | Dietary Supplement: Resistant Starch Type 4-RawResistant starch type 4-Raw |
| 3 | Experimental | Dietary Supplement: Resistant Starch Type 4-CookedResistant starch type 4-Cooked |
| 4 | Experimental | Dietary Supplement: Resistant Starch Type 4-CookedResistant starch type 4-Cooked |
| 5 | Placebo comparator | Dietary Supplement: Shredded WheatShredded wheat |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 Diabetics
Key exclusion criteria (3 listed)
- Diagnosed with 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-RawLow Dose- 70g bar | Dietary supplement | 1 |
| Resistant Starch Type 4-RawHigh Dose- 100g bar | Dietary supplement | 2 |
| Resistant Starch Type 4-CookedLow Dose- 70g bar | Dietary supplement | 3 |
| Resistant Starch Type 4-CookedHigh dose: 100g bar | Dietary supplement | 4 |
| Shredded Wheat70g bar | Dietary supplement | 5 |
Primary outcome
Post-Prandial metabolism
Time frame: Acute -- fasting, 15, 30, 45, 60, 90 and 120 minutes post-ingestion
1 secondary outcome
Satiety
Time frame: Early morning - Midafternoon
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 Jul 2009.
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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 Shredded Wheat 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 1 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 Jul 2009. 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: Acute -- fasting, 15, 30, 45, 60, 90 and 120 minutes post-ingestion). 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 Jul 2009.