Postprandial HyperglycemiaNCT05349916
The Attenuating Effect of Soluble Fiber Consumption on Postprandial Glycemia in Humans
A study testing Isomaltodextrin Low Dose, Isomaltodextrin High Dose and GPC partially digestible maltodextrin in people with Postprandial Hyperglycemia and Type2 Diabetes, run by Purdue University at 1 site in United States.
Trial summary
The main objective of the current study is to investigate whether consumption of soluble fibers (isomaltodextrin [IMD], partially digestible maltodextrin) and RS4 starch will lower postprandial glycemia as well as postprandial insulin in human subjects with relatively high fasting blood glucose, when consumed with a… Read more about this study
- Who is it for?
- Ages 22 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia, Type2 Diabetes, Blood Sugar; High
- What is being tested?
- Isomaltodextrin Low Dose, Isomaltodextrin High Dose and GPC partially digestible maltodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2021to 9 Mar 2022
- 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 22 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (18.5 kg/m² ≤ BMI ≤ 29.9 kg/m²)
- No history of abnormal glucose metabolism
- No ongoing use of drugs affecting blood glucose levels
- Fasting blood glucose between 90-110 mg/dL
- Low dietary fiber intake (less than 15 g per day)
Who cannot join
- Diabetic individuals
- Individuals with history of gastrointestinal disease
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the current study is to investigate whether consumption of soluble fibers (isomaltodextrin [IMD], partially digestible maltodextrin) and RS4 starch will lower postprandial glycemia as well as postprandial insulin in human subjects with relatively high fasting blood glucose, when consumed with a specific amount of digestible carbohydrate (rice porridge). The primary outcome of the study is the effect of fibers on postprandial blood glucose, whereas the secondary outcome will be its effect on postprandial blood insulin.
- Being tested
- Control, Isomaltodextrin Low Dose, Isomaltodextrin High Dose, GPC partially digestible maltodextrin, Resistant Starch Type 4
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
300 g rice porridge + 150 ml drinking water
Isomaltodextrin Low DoseOther
300 g rice porridge + (5 g IMD in 150 ml drinking water)
Isomaltodextrin High DoseOther
300 g rice porridge + (10 g IMD in 150 ml drinking water)
GPC partially digestible maltodextrinOther
300 g rice porridge + (15 g GPC fiber in 150 ml drinking water)
Resistant Starch Type 4Other
300 g rice porridge + (15 g RS4 starch in 150 ml drinking water)
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Not described Receives: Other: Control |
| Isomaltodextrin Low Dose | Experimental | Not described Receives: Other: Isomaltodextrin Low Dose |
| Isomaltodextrin High Dose | Experimental | Not described Receives: Other: Isomaltodextrin High Dose |
| GPC partially digestible maltodextrin | Experimental | Not described Receives: Other: GPC partially digestible maltodextrin |
| Resistant Starch Type 4 | Experimental | Not described Receives: Other: Resistant Starch Type 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemic response
Blood glucose will be measured, (AUC)
Measured: Acute study: [3 hours of measurement after consumption of test food]
Postprandial glycemic response
Blood glucose will be measured, (C max)
Measured: Acute study: [3 hours of measurement after consumption of test food]
Postprandial glycemic response
Blood glucose will be measured, (t max)
Measured: Acute study: [3 hours of measurement after consumption of test food]
Secondary outcomes (3)
Postprandial insulin response
Blood insulin will be measured, (AUC)
Measured: Acute study: [3 hours of measurement after consumption of test food]
Postprandial insulin response
Blood insulin will be measured, (C max)
Measured: Acute study: [3 hours of measurement after consumption of test food]
Postprandial insulin response
Blood insulin will be measured, (t max)
Measured: Acute study: [3 hours of measurement after consumption of test food]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start7 Dec 2021
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Grain processing corporation
- Responsible party
- Principal investigator, Bruce R. Hamaker, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349916
- Sponsor's protocol ID
- IRB-2021-122
- Status last verified
- Apr 2022
- First submitted
- 17 Oct 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Attenuating Effect of Soluble Fiber Consumption on Postprandial Glycemia in Humans
- ClinicalTrials.gov ID
- NCT05349916
- Acronym / sponsor ID
- IRB-2021-122
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Grain processing corporation
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 27 Apr 2022 (actual)
- 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 main objective of the current study is to investigate whether consumption of soluble fibers (isomaltodextrin [IMD], partially digestible maltodextrin) and RS4 starch will lower postprandial glycemia as well as postprandial insulin in human subjects with relatively high fasting blood glucose, when consumed with a specific amount of digestible carbohydrate (rice porridge). The primary outcome of the study is the effect of fibers on postprandial blood glucose, whereas the secondary outcome will be its effect on postprandial blood insulin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: Control |
| Isomaltodextrin Low Dose | Experimental | Other: Isomaltodextrin Low Dose |
| Isomaltodextrin High Dose | Experimental | Other: Isomaltodextrin High Dose |
| GPC partially digestible maltodextrin | Experimental | Other: GPC partially digestible maltodextrin |
| Resistant Starch Type 4 | Experimental | Other: Resistant Starch Type 4 |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (18.5 kg/m² ≤ BMI ≤ 29.9 kg/m²)
- No history of abnormal glucose metabolism
- No ongoing use of drugs affecting blood glucose levels
- Fasting blood glucose between 90-110 mg/dL
- Low dietary fiber intake (less than 15 g per day)
Key exclusion criteria (3 listed)
- Diabetic individuals
- Individuals with history of gastrointestinal disease
- Pregnant or nursing women
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 |
|---|---|---|
| Control300 g rice porridge + 150 ml drinking water | Other | Control |
| Isomaltodextrin Low Dose300 g rice porridge + (5 g IMD in 150 ml drinking water) | Other | Isomaltodextrin Low Dose |
| Isomaltodextrin High Dose300 g rice porridge + (10 g IMD in 150 ml drinking water) | Other | Isomaltodextrin High Dose |
| GPC partially digestible maltodextrin300 g rice porridge + (15 g GPC fiber in 150 ml drinking water) | Other | GPC partially digestible maltodextrin |
| Resistant Starch Type 4300 g rice porridge + (15 g RS4 starch in 150 ml drinking water) | Other | Resistant Starch Type 4 |
Primary outcome
Postprandial glycemic response
Time frame: Acute study: [3 hours of measurement after consumption of test food]
Blood glucose will be measured, (AUC)
Postprandial glycemic response
Time frame: Acute study: [3 hours of measurement after consumption of test food]
Blood glucose will be measured, (C max)
Postprandial glycemic response
Time frame: Acute study: [3 hours of measurement after consumption of test food]
Blood glucose will be measured, (t max)
3 secondary outcomes
Postprandial insulin response
Time frame: Acute study: [3 hours of measurement after consumption of test food]
Postprandial insulin response
Time frame: Acute study: [3 hours of measurement after consumption of test food]
Postprandial insulin response
Time frame: Acute study: [3 hours of measurement after consumption of test food]
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 27 Apr 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isomaltodextrin Low Dose, Isomaltodextrin High Dose and GPC partially digestible maltodextrin in people with Postprandial Hyperglycemia and Type2 Diabetes, 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 5 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 27 Apr 2022. 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?
Postprandial glycemic response (time frame: Acute study: [3 hours of measurement after consumption of test food]). The study lists 3 primary outcomes in all. 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 27 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.