A Phase 1 interventional study of Acetylated and Butyrylated High Amylose Maize Starch in Type 1 Diabetes, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Indiana University · Phase 1, Interventional, and Treatment
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Taking fiber supplements
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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.
Drug: Acetylated and Butyrylated High Amylose Maize Starch
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.
Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner for 4 weeks
Also known as: Hylon™ VII Butyrate, Hylon™ VII Acetate
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.
Time frame: before and after completion of each 4 week sequence
Changes in the Short Chain Fatty Acid Levels in the Gut.
Measurement of Short Chain Fatty Acid Levels in the Stools.
Time frame: 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.
Time frame: 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).
Time frame: before and after completion of each 4 week sequence
Changes in Frequency of Mucosal Associated Invariant T (MAIT) Cells
We will compare changes in MAIT cell frequency (as measured by % of CD3 T cells that are MAIT cells) before and after the interventions
Time frame: before and after completion of each 4 week sequence
Changes in Function of Mucosal Associated Invariant T (MAIT) Cells
We will compare changes in % of MAIT cell with CD25 function before and after the interventions
Time frame: before and after completion of each 4 week sequence
Changes in Phenotype of Mucosal Associated Invariant T (MAIT) Cells
We will compare changes in % of MAIT cells with a BCL2-GzB+ phenotype before and after the interventions
Time frame: before and after completion of each 4 week sequence
| Milestone | Supplement Intervention and Control Diet, Then Control Diet Alone | Control Diet Alone, Then Supplement Intervention and Control Diet |
|---|---|---|
| Started | 6 | 6 |
| Completed | 3 | 4 |
| Not completed | 3 | 2 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Milestone | Supplement Intervention and Control Diet, Then Control Diet Alone | Control Diet Alone, Then Supplement Intervention and Control Diet |
|---|---|---|
| Started | 3 | 4 |
| Completed | 3 | 3 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
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.
| species count | Supplement Intervention and Control Diet | Control Diet Alone |
|---|---|---|
| Baseline Bifidobacterium Longum | 818.5 (110 to 1280) | 229 (49 to 609) |
| Bifidobacteria Longum (after 4 weeks) | 1610 (382 to 1819.5) | 177 (75.5 to 924.5) |
| Baseline Parabacteroides distasonis | 4964 (0 to 9782) | 2632 (1407 to 5179.5) |
| Parabacteroides distasonis (after 4 weeks) | 561 (55 to 3556) | 561 (136 to 2986) |
Measurement of Short Chain Fatty Acid Levels in the Stools.
| mmol / kg fecal material | Supplement Intervention and Control Diet | Control Diet Alone |
|---|---|---|
| Butyrate | 23 ± 6 | 19 ± 5 |
| Propionate | 16 ± 9 | 16 ± 5 |
| acetate | 60 ± 23 | 56 ± 18 |
We will compare average glucose changes pre/post intervention with HAMS-AB. We will compare their glycemic changes using continuous glucose monitoring data.
| mg/dl | Supplement Intervention and Control Diet | Control Diet Alone |
|---|---|---|
| baseline | 256 ± 19 | 228 ± 13 |
| 4 weeks after | 232 ± 31 | 217 ± 27 |
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).
| ng/ml | Supplement Intervention and Control Diet | Control Diet Alone |
|---|---|---|
| baseline | 2.0 ± 0.3 | 1.7 ± 0.3 |
| after 4 weeks | 2.7 ± 0.6 | 2.6 ± 0.4 |
We will compare changes in MAIT cell frequency (as measured by % of CD3 T cells that are MAIT cells) before and after the interventions
| percentage of CD3 T cells | Supplement Intervention and Control Diet | Control Diet Alone |
|---|---|---|
| Baseline | 2.3 | 1.6 |
| after 4 weeks | 2.1 | 2.4 |
We will compare changes in % of MAIT cell with CD25 function before and after the interventions
| percentage of MAIT cells | Supplement Intervention and Control Diet | Control Diet Alone |
|---|---|---|
| before | 4.7 | 3.8 |
| after | 3.2 | 4.0 |
We will compare changes in % of MAIT cells with a BCL2-GzB+ phenotype before and after the interventions
| percentage of MAIT cells | Supplement Intervention and Control Diet | Control Diet Alone |
|---|---|---|
| before | 16.7 | 11.5 |
| after | 5.4 | 9.0 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/9 (0%) | 0/9 (0%) | 7/9 (77.8%) |
| Control Group | 0/10 (0%) | 0/10 (0%) | 7/10 (70%) |
| Event | Intervention Group | Control Group |
|---|---|---|
| constipationGastrointestinal disorders | 0/9 | 2/10 |
| Dental PainMusculoskeletal and connective tissue disorders | 1/9 | 0/10 |
| coldInfections and infestations | 1/9 | 0/10 |
| NauseaGastrointestinal disorders | 1/9 | 0/10 |
| abdominal painGastrointestinal disorders | 1/9 | 0/10 |
| yeast infectionInfections and infestations | 1/9 | 0/10 |
| flatulenceGastrointestinal disorders | 1/9 | 0/10 |
| emesisGastrointestinal disorders | 1/9 | 0/10 |
| anxietyInvestigations | 0/9 | 1/10 |
| bilateral halux infectionInfections and infestations | 0/9 | 1/10 |
| Age, Continuous(years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 14.98 ± 1.92 | 13.58 ± 1.07 | 14.28 ± 1.73 |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Female | 6 | 4 | 10 |
| Male | 0 | 2 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 1 | 7 |
| Not Hispanic or Latino | 0 | 5 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 5 | 5 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| United States | 6 | 6 | 12 |
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Indiana University