Hyperglycemia, Diabetes, and ObesityNCT02161250
Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses
A study testing Resistant Starch in people with Hyperglycemia, Diabetes, and Obesity, run by Purdue University at 1 site in United States.
Trial summary
Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to beverage with maltodextrin (an easily digested carbohydrate). Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Diabetes, and Obesity
- What is being tested?
- Resistant Starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2014
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Thirty healthy men and women (aged 18-29y) will be recruited from the greater Lafayette, IN region with the expectation that ≥20 subjects will complete the study. Subjects must weigh >110 pounds, with a BMI between 20.0 and 29.9.
Who cannot join
- Weight change > 3kg in the past 3 months
- Exercising vigorously over the past 3 months as well as no exercise 3 days prior to testing day
- Intestinal disorders including lipid mal-absorption or lactose intolerance
- Abnormal liver or kidney function tests; fasting blood glucose >100mg/dL
- Smoking
- Drinking more than 2 alcoholic drinks per day
- Taking lipid-lowering medications or dietary supplements affecting plasma cholesterol concentration.
- Subjects must not be pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to beverage with maltodextrin (an easily digested carbohydrate).
Read the detailed description
- About two-thirds of adults in the United States are overweight or obese which can cause adverse health consequences for those individuals. Post-prandial hyperglycemia is one of these possible consequences and is associated with a higher risk for Type 2 Diabetes. Controlling hyperglycemia is important in the prevention of the onset of diabetes and obesity. Resistant starch is a dietary carbohydrate which is not completely digested in the gut and produces energy for the body to use. The investigators are interested in assessing the effects of resistant starch on postprandial blood glucose and insulin concentrations.
- Aim: To assess the effects of a resistant starch on post-prandial blood glucose and insulin concentrations.
- Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to a beverage with maltodextrin (an easily digested carbohydrate).
- Conditions
- Hyperglycemia, Diabetes, and Obesity
- Being tested
- Resistant Starch, Control
- 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
Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing resistant starch. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.
ControlDietary supplement
Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing maltodextrin. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.
| Study group | Role | What they receive |
|---|---|---|
| Resistant starch | Experimental | The test beverage consumed has the resistant starch. Receives: Dietary Supplement: Resistant Starch |
| Control | Experimental | The control beverage uses maltodextrin rather than the resistant starch. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
resistant starch effects
effects of resistant starch consumption of area under the curve of blood serum glucose, insulin, and hydrogen breath testing.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycemia, Diabetes, and ObesityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Ingredion Incorporated
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne Campbell, Phd, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161250
- Sponsor's protocol ID
- 1312014354
- Status last verified
- Jun 2014
- First submitted
- 9 Jun 2014
- Last updated
- 12 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses
- ClinicalTrials.gov ID
- NCT02161250
- Acronym / sponsor ID
- 1312014354
- Conditions
- Hyperglycemia, Diabetes, and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Ingredion Incorporated
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Jun 2014 (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.
Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to beverage with maltodextrin (an easily digested carbohydrate).
Detailed description
- About two-thirds of adults in the United States are overweight or obese which can cause adverse health consequences for those individuals. Post-prandial hyperglycemia is one of these possible consequences and is associated with a higher risk for Type 2 Diabetes. Controlling hyperglycemia is important in the prevention of the onset of diabetes and obesity. Resistant starch is a dietary carbohydrate which is not completely digested in the gut and produces energy for the body to use. The investigators are interested in assessing the effects of resistant starch on postprandial blood glucose and insulin concentrations.
- Aim: To assess the effects of a resistant starch on post-prandial blood glucose and insulin concentrations.
- Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to a beverage with maltodextrin (an easily digested carbohydrate).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistant starch | Experimental | Dietary Supplement: Resistant StarchThe test beverage consumed has the resistant starch. |
| Control | Experimental | Dietary Supplement: ControlThe control beverage uses maltodextrin rather than the resistant starch. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Thirty healthy men and women (aged 18-29y) will be recruited from the greater Lafayette, IN region with the expectation that ≥20 subjects will complete the study. Subjects must weigh >110 pounds, with a BMI between 20.0 and 29.9.
Key exclusion criteria (8 listed)
- Weight change > 3kg in the past 3 months
- Exercising vigorously over the past 3 months as well as no exercise 3 days prior to testing day
- Intestinal disorders including lipid mal-absorption or lactose intolerance
- Abnormal liver or kidney function tests; fasting blood glucose >100mg/dL
- Smoking
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 StarchEach subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing resistant starch. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar. | Dietary supplement | Resistant starch |
| ControlEach subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing maltodextrin. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar. | Dietary supplement | Control |
Primary outcome
resistant starch effects
Time frame: 2 weeks
effects of resistant starch consumption of area under the curve of blood serum glucose, insulin, and hydrogen breath testing.
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 12 Jun 2014.
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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.
Wayne Campbell, Phd principal investigator
Purdue 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 Hyperglycemia, Diabetes, and Obesity, run by Purdue 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 8 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 12 Jun 2014. 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?
resistant starch effects (time frame: 2 weeks). 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 12 Jun 2014.