HyperglycemiaNCT00676767
Resistant Starch on Glycemic Response in Older Adults
A study testing Resistant Starch Type 4, Dextrose and Puffed wheat in people with Hyperglycemia, run by Kansas State University at 1 site in United States.
Trial summary
The purpose of this study was to determine how blood glucose changes after eating energy bars containing resistant starch type 4 compared with bars made with puffed wheat in healthy older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Resistant Starch Type 4, Dextrose and Puffed wheat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Nov 2006
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy (not diagnosed with disease)
- Over 60 years of age
Who cannot join
- Diagnosed with diabetes or other metabolic disorder
- Allergies to wheat
- Non-smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Metabolism Laboratory
Manhattan, Kansas, 66506
About this study
Official title: Resistant Starch Type 4 on the Glycemic Response in Older Adults
The purpose of this study was to determine how blood glucose changes after eating energy bars containing resistant starch type 4 compared with bars made with puffed wheat in healthy older adults.
Read the detailed description
To measure the blood glucose response, we collected blood samples 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.
- Conditions
- Hyperglycemia
- Being tested
- Resistant Starch Type 4, Dextrose, Puffed wheat
- Keywords
- Aging, 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 4Dietary supplement
DextroseDietary supplement
Puffed wheatDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: Resistant Starch Type 4 |
| 2 | Active comparator | Not described Receives: Dietary Supplement: Dextrose |
| 3 | Placebo comparator | Not described Receives: Dietary Supplement: Puffed wheat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Response
Measured: 2-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startAug 2006
- Primary completionNov 2006
- Study completionNov 2006
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Collaborators
- MGP Ingredients, Inc.
- Investigators
- Mark D Haub, Ph.D, Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676767
- Sponsor's protocol ID
- KSU-HML-RSt1
- Status last verified
- May 2008
- First submitted
- 8 May 2008
- Last updated
- 23 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistant Starch Type 4 on the Glycemic Response in Older Adults
- ClinicalTrials.gov ID
- NCT00676767
- Acronym / sponsor ID
- KSU-HML-RSt1
- Conditions
- Hyperglycemia
- Keywords
- Aging, Diabetes, Diet, Fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Collaborators
- MGP Ingredients, Inc.
- Study start
- Aug 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 13 May 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.
The purpose of this study was to determine how blood glucose changes after eating energy bars containing resistant starch type 4 compared with bars made with puffed wheat in healthy older adults.
Detailed description
To measure the blood glucose response, we collected blood samples 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Resistant Starch Type 4 |
| 2 | Active comparator | Dietary Supplement: Dextrose |
| 3 | Placebo comparator | Dietary Supplement: Puffed wheat |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Apparently healthy (not diagnosed with disease)
- Over 60 years of age
Key exclusion criteria (3 listed)
- Diagnosed with diabetes or other metabolic disorder
- 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 | Dietary supplement | 1 |
| Dextrose | Dietary supplement | 2 |
| Puffed wheat | Dietary supplement | 3 |
Primary outcome
Glycemic Response
Time frame: 2-hours
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 23 May 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 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 Type 4, Dextrose and Puffed 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 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 23 May 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?
Glycemic Response (time frame: 2-hours). 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 23 May 2008; AzTrials last refreshed its copy on 6 Nov 2026.