Postprandial HyperglycemiaNCT00930956
Comparison of Different Types of Resistant Starch
A study testing Resistant Starch in people with Postprandial Hyperglycemia, run by Kansas State University at 1 site in United States.
Trial summary
This study is to determine whether different types of resistant starch have different effects on blood glucose in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- Resistant Starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to May 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- apparently healthy
Who cannot join
- diagnosis of any chronic disease
- wheat allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Metabolism Laboratory (K-State Univ.)
Manhattan, Kansas, 66502
About this study
Official title: Resistant Starch Type 2 and Cross Linked Resistant Starch Type 4 on Blood Glucose
This study is to determine whether different types of resistant starch have different effects on blood glucose in healthy adults.
Read the detailed description
Each volunteer will visit the laboratory in a 10-12 hour fasted state on three occasions over a three-week period, up to two visits/wk, with at least 48 hours between visits. Volunteers will be asked to refrain from vigorous physical activity and the consumption of alcohol the day before each testing visit. Randomization using a Latin Square design was applied to minimize confounding issues associated with the order of administration.
In the morning of each test, a finger-prick capillary blood samples will be collected to determine fasting (baseline) blood glucose levels. The volunteers will then consume the test solution assigned for that trial. Ten minutes will be allowed for the test solution to be consumed. Over the two hours following the start of each test, finger-prick capillary blood samples were collected at 30, 60, 90, and 120 min. Blood glucose levels will be immediately measured in duplicate using an automated blood glucose analyzer (YSI 2300, Yellow Springs, OH). Analysis of the collected sample was repeated if the difference between duplicate samples was greater than 0.1 mmol/L. Once the samples were analyzed, the data was entered and the incremental area under the curve was calculated using the trapezoidal model (GraphPad v5.0, La Jolla, CA).
- Conditions
- Postprandial Hyperglycemia
- Being tested
- Resistant Starch
- Keywords
- Diabetes, Obesity, Hyperglycemia, Dietary Fiber, Wheat, Grain
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant StarchDietary supplement
Also called Hi-Maize 260, Fibersym RW
30 g of carbohydrate per Arm
| Study group | Role | What they receive |
|---|---|---|
| Dextrose | Active comparator | 30 g of carbohydrate via Sun-Dex OGTT beverage Receives: Dietary Supplement: Resistant Starch |
| RS Type 2 | Experimental | 30g Resistant Starch Type 2 (Hi-Maize 260, National Starch) Receives: Dietary Supplement: Resistant Starch |
| RS Type 4 (cross linked) | Experimental | 30g of cross linked RS type 4 (Fibersym RW, MGP Ingredients, Inc.) Receives: Dietary Supplement: Resistant Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Measured: Acute response -- fasting and 30, 60, 90 and 120 minutes post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startMay 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Investigators
- Mark D Haub, Ph.D., Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930956
- Sponsor's protocol ID
- KSUHML09-RS
- Status last verified
- Jun 2009
- First submitted
- 30 Jun 2009
- Last updated
- 29 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistant Starch Type 2 and Cross Linked Resistant Starch Type 4 on Blood Glucose
- ClinicalTrials.gov ID
- NCT00930956
- Acronym / sponsor ID
- KSUHML09-RS
- Conditions
- Postprandial Hyperglycemia
- Keywords
- Diabetes, Obesity, Hyperglycemia, Dietary Fiber, Wheat, Grain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 2 Jul 2009 (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 is to determine whether different types of resistant starch have different effects on blood glucose in healthy adults.
Detailed description
Each volunteer will visit the laboratory in a 10-12 hour fasted state on three occasions over a three-week period, up to two visits/wk, with at least 48 hours between visits. Volunteers will be asked to refrain from vigorous physical activity and the consumption of alcohol the day before each testing visit. Randomization using a Latin Square design was applied to minimize confounding issues associated with the order of administration.
In the morning of each test, a finger-prick capillary blood samples will be collected to determine fasting (baseline) blood glucose levels. The volunteers will then consume the test solution assigned for that trial. Ten minutes will be allowed for the test solution to be consumed. Over the two hours following the start of each test, finger-prick capillary blood samples were collected at 30, 60, 90, and 120 min. Blood glucose levels will be immediately measured in duplicate using an automated blood glucose analyzer (YSI 2300, Yellow Springs, OH). Analysis of the collected sample was repeated if the difference between duplicate samples was greater than 0.1 mmol/L. Once the samples were analyzed, the data was entered and the incremental area under the curve was calculated using the trapezoidal model (GraphPad v5.0, La Jolla, CA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dextrose | Active comparator | Dietary Supplement: Resistant Starch30 g of carbohydrate via Sun-Dex OGTT beverage |
| RS Type 2 | Experimental | Dietary Supplement: Resistant Starch30g Resistant Starch Type 2 (Hi-Maize 260, National Starch) |
| RS Type 4 (cross linked) | Experimental | Dietary Supplement: Resistant Starch30g of cross linked RS type 4 (Fibersym RW, MGP Ingredients, Inc.) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- apparently healthy
Key exclusion criteria (2 listed)
- diagnosis of any chronic disease
- wheat allergy
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 StarchAlso: Hi-Maize 260, Fibersym RW30 g of carbohydrate per Arm | Dietary supplement | Dextrose, RS Type 2, RS Type 4 (cross linked) |
Primary outcome
Blood glucose
Time frame: Acute response -- fasting and 30, 60, 90 and 120 minutes post-ingestion
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 29 Jul 2010.
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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 D Haub, Ph.D. principal investigator
Kansas State 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 Resistant Starch in people with Postprandial 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 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 29 Jul 2010. 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?
Blood glucose (time frame: Acute response -- fasting and 30, 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 29 Jul 2010.