Type 1 DiabetesPhase 1NCT04114357
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
A Phase 1 study testing Acetylated and Butyrylated High Amylose Maize Starch in people with Type 1 Diabetes, run by Indiana University at 1 site in United States.
Trial summary
Data suggest that intestinal microbiota might be critically involved both in autoimmunity and in glucose homeostasis. An acetylated and butyrylated form of high amylose maize starch (HAMS-AB) that increases beneficial short chain fatty acid (SCFA) production has been safe and effective in disease prevention in mouse… Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Acetylated and Butyrylated High Amylose Maize Starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2020to 9 Jun 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be between 11-17 years of age
- Willing to consume HAMS-AB and follow a diabetic diet
- Diagnosed by American Diabetes Association criteria with T1D in the last 4-36 months
- Random non-fasting C-peptide of 0.17nmol/ml or greater
- Willing to use an effective form of contraception if sexually active
- BMI< 85% for age and sex
- Positive for any one of the following diabetes-related autoantibodies that are tested clinically [insulin autoantibody (if tested within 14 days of diagnosis), glutamic acid decarboxylase (GAD), insulinoma-associated protein-2 (IA-2), or Zinc transporter 8 autoantibodies (ZnT8)].
Who cannot join
- Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, except for well-controlled hypothyroidism and mild asthma not requiring oral steroids.
- Diabetes other than T1D (Known monogenic forms of diabetes, Type 2 diabetes)
- Chronic illness known to affect glucose metabolism (e.g. Cushing syndrome, polycystic ovarian disorder, cystic fibrosis) or taking medications that affect glucose metabolism (e.g. steroids, metformin)
- Psychiatric impairment or current use of anti-psychotic medication
- Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.
- Female participants of child-bearing age with reproductive potential, must not be pregnant and agree to use an effective form of birth control or be abstinent during the study period (see below)
Show all 21Show fewer
- History of recurrent infections
- History of on-going infections or antibiotic treatment within the past three months
- History of immune compromise
- Steroid intake (inhaled or oral)
- Other immunosuppressant use in past 6 months
- History of gastrointestinal disease
- Possible or confirmed celiac disease
- Pregnancy or possible pregnancy
- Allergy to corn (prebiotic)
- Allergy to milk or milk products or soy present in Boost
- Participation in other intervention research trials within the past 3 months
- Anticipate major changes in diabetes management during study (change from injection to pump, new start of continuous glucose monitoring)
- Consuming high fiber or vegetarian diet (consuming three or more servings of high fiber foods on 4 or more days per week) using validated dietary assessments (see below under schedule of events table).
- Taking fiber supplements
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: Evaluating the Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function in Newly Diagnosed Type 1 Diabetes
Data suggest that intestinal microbiota might be critically involved both in autoimmunity and in glucose homeostasis. An acetylated and butyrylated form of high amylose maize starch (HAMS-AB) that increases beneficial short chain fatty acid (SCFA) production has been safe and effective in disease prevention in mouse type 1 diabetes (T1D) models. The objective of this application is to assess the effect of administering a prebiotic, such as HAMS- AB, on the gut microbiome profile, glycemia and β-cell function in humans with T1D.
Read the detailed description
This is a pilot, single center clinical trial to evaluate the effect of using the prebiotic, HAMS-AB, on the gut microbiome profile, glycemia and β-cell function in children and adolescents ages 12-16 years with recently diagnosed type 1 diabetes.
Approximately 12 participants will be randomized to first to take the supplement and follow the diabetic diet or follow a diabetic diet alone for 4 weeks and then cross-over after a 4 week washout period.
The primary objective is to determine the effect of using the prebiotic on the gut microbiome profile in youth with T1D.
The secondary objectives are to determine the effect of using the prebiotic on SCFA production, glycemia and β-cell health and function.
Exploratory outcomes include changes in MAIT cells.
- Conditions
- Type 1 Diabetes
- Being tested
- Acetylated and Butyrylated High Amylose Maize Starch
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylated and Butyrylated High Amylose Maize StarchDrug
Also called Hylon™ VII Butyrate, Hylon™ VII Acetate
Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Supplement Intervention and Control Diet, then Control Diet Alone | Experimental | This group will first consume the supplement daily for 4 weeks in addition to the diabetic diet then cross-over to follow the diabetic diet for 4 weeks. Receives: Drug: Acetylated and Butyrylated High Amylose Maize Starch |
| Control Diet Alone, then Supplement Intervention and Control Diet | No intervention | This group will follow the control diet for 4 weeks first then cross-over to receive the supplement for 4 weeks in addition to the diabetic diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Gut Microbiome Profile
We planned to assess the effect of administering acetylated and butyrylated high amylose maize starch (HAMS-AB) on the gut microbiome profile in people with recently-diagnosed type 1 diabetes (T1D) by sequencing the gut microbiome profile.
This measure was assesed using the absolute abundance of certain bacterial species of interest.
The changes will be compared before and after each 4 week time period.
Measured: before and after completion of each 4 week sequence
Secondary outcomes (3)
Changes in the Short Chain Fatty Acid Levels in the Gut.
Measurement of Short Chain Fatty Acid Levels in the Stools.
Measured: before and after completion of each 4 week sequence
Changes in Average Glucose
We will compare average glucose changes pre/post intervention with HAMS-AB. We will compare their glycemic changes using continuous glucose monitoring data.
Measured: before and after completion of each 4 week sequence
C-peptide Levels (Changes in Beta Cell Health).
We will compare β-cell measures pre/post intervention with HAMS-AB and between the intervention and control groups. We will assess β-cell function using mixed meal tolerance-derived C-peptide measurements ( a measure of β-cell function).
Measured: before and after completion of each 4 week sequence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start22 Jun 2020
- Primary completion9 Jun 2023
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Heba M. Ismail, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114357
- Sponsor's protocol ID
- 1907172784
- Other IDs
- KL2TR002530, UL1TR002529
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2019
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ismail HM, Spall M, Evans-Molina C, DiMeglio LA. Evaluating the effect of prebiotics on the gut microbiome profile and beta cell function in youth with newly diagnosed type 1 diabetes: protocol of a pilot randomized controlled trial. Pilot Feasibility Stud. 2023 Aug 25;9(1):150. doi: 10.1186/s40814-023-01373-4.
PubMed 37626387
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function in Newly Diagnosed Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04114357
- Acronym / sponsor ID
- 1907172784
- Conditions
- Type 1 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Data suggest that intestinal microbiota might be critically involved both in autoimmunity and in glucose homeostasis. An acetylated and butyrylated form of high amylose maize starch (HAMS-AB) that increases beneficial short chain fatty acid (SCFA) production has been safe and effective in disease prevention in mouse type 1 diabetes (T1D) models. The objective of this application is to assess the effect of administering a prebiotic, such as HAMS- AB, on the gut microbiome profile, glycemia and β-cell function in humans with T1D.
Detailed description
This is a pilot, single center clinical trial to evaluate the effect of using the prebiotic, HAMS-AB, on the gut microbiome profile, glycemia and β-cell function in children and adolescents ages 12-16 years with recently diagnosed type 1 diabetes.
Approximately 12 participants will be randomized to first to take the supplement and follow the diabetic diet or follow a diabetic diet alone for 4 weeks and then cross-over after a 4 week washout period.
The primary objective is to determine the effect of using the prebiotic on the gut microbiome profile in youth with T1D.
The secondary objectives are to determine the effect of using the prebiotic on SCFA production, glycemia and β-cell health and function.
Exploratory outcomes include changes in MAIT cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement Intervention and Control Diet, then Control Diet Alone | Experimental | Drug: Acetylated and Butyrylated High Amylose Maize StarchThis group will first consume the supplement daily for 4 weeks in addition to the diabetic diet then cross-over to follow the diabetic diet for 4 weeks. |
| Control Diet Alone, then Supplement Intervention and Control Diet | No intervention | –This group will follow the control diet for 4 weeks first then cross-over to receive the supplement for 4 weeks in addition to the diabetic diet. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Be between 11-17 years of age
- Willing to consume HAMS-AB and follow a diabetic diet
- Diagnosed by American Diabetes Association criteria with T1D in the last 4-36 months
- Random non-fasting C-peptide of 0.17nmol/ml or greater
- Willing to use an effective form of contraception if sexually active
Key exclusion criteria (21 listed)
- Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, except for well-controlled hypothyroidism and mild asthma not requiring oral steroids.
- Diabetes other than T1D (Known monogenic forms of diabetes, Type 2 diabetes)
- Chronic illness known to affect glucose metabolism (e.g. Cushing syndrome, polycystic ovarian disorder, cystic fibrosis) or taking medications that affect glucose metabolism (e.g. steroids, metformin)
- Psychiatric impairment or current use of anti-psychotic medication
- Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.
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 |
|---|---|---|
| Acetylated and Butyrylated High Amylose Maize StarchAlso: Hylon™ VII Butyrate, Hylon™ VII AcetateParticipants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner for 4 weeks | Drug | Supplement Intervention and Control Diet, then Control Diet Alone |
Primary outcome
Change in the Gut Microbiome Profile
Time frame: before and after completion of each 4 week sequence
We planned to assess the effect of administering acetylated and butyrylated high amylose maize starch (HAMS-AB) on the gut microbiome profile in people with recently-diagnosed type 1 diabetes (T1D) by sequencing the gut microbiome profile. This measure was assesed using the absolute abundance of certain bacterial species of interest. The changes will be compared before and after each 4 week time period.
3 secondary outcomes
Changes in the Short Chain Fatty Acid Levels in the Gut.
Time frame: before and after completion of each 4 week sequence
Changes in Average Glucose
Time frame: before and after completion of each 4 week sequence
C-peptide Levels (Changes in Beta Cell Health).
Time frame: before and after completion of each 4 week sequence
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37626387Ismail HM, Spall M, Evans-Molina C, DiMeglio LA. Evaluating the effect of prebiotics on the gut microbiome profile and beta cell function in youth with newly diagnosed type 1 diabetes: protocol of a pilot randomized controlled trial. Pilot Feasibility Stud. 2023 Aug 25;9(1):150. doi: 10.1186/s40814-023-01373-4.
- 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 Phase 1 study testing Acetylated and Butyrylated High Amylose Maize Starch in people with Type 1 Diabetes, run by Indiana 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 7 inclusion and 21 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 1 Oct 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the Gut Microbiome Profile (time frame: before and after completion of each 4 week sequence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114357, which also lists 1 linked publication.
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 1 Oct 2024.