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Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Acetylated and Butyrylated High Amylose Maize Starch

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)].

Exclusion Criteria:

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)
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
-

Sites / Locations

Indiana University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

This arm will consume the supplement daily for 4 weeks.

This arm will not receive the supplement for 4 weeks.

Outcomes

Primary Outcome Measures

Change in the gut microbiome profile

We plan to assess the effect of administering HAMS-AB on the gut microbiome profile in people with recently-diagnosed T1D by sequencing the gut microbiome profile.

Secondary Outcome Measures

Changes in the Short Chain Fatty Acid Levels in the Gut.

Measurement of Short Chain Fatty Acid Levels in the Stools.

Changes in Glycemia.

We will compare glycemic changes pre/post intervention with HAMS-AB and between the intervention and control groups. We will measure glycemia using HbA1c, average glucose and glucose variability using blinded continuous glucose monitoring.

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 measures. We will assess β-cell stress using fasting proinsulin/C-peptide (PI:C) ratios. We will assess β-cell death by differential methylation of preproinsulin (INS) DNA.

Full Information

NCT ID

NCT04114357

First Posted

September 30, 2019

Last Updated

July 17, 2023

Sponsor

Indiana University

Collaborators

National Center for Advancing Translational Sciences (NCATS)

1. Study Identification

Unique Protocol Identification Number

NCT04114357

Brief Title

Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function

Official Title

Evaluating the Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function in Newly Diagnosed Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

June 22, 2020 (Actual)

Primary Completion Date

June 9, 2023 (Actual)

Study Completion Date

June 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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 first to take the supplement or follow a diabetic diet 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

This arm will consume the supplement daily for 4 weeks.

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

This arm will not receive the supplement for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Acetylated and Butyrylated High Amylose Maize Starch

Other Intervention Name(s)

Hylon™ VII Butyrate, Hylon™ VII Acetate

Intervention Description

Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner

Primary Outcome Measure Information:

Title

Change in the gut microbiome profile

Description

We plan to assess the effect of administering HAMS-AB on the gut microbiome profile in people with recently-diagnosed T1D by sequencing the gut microbiome profile.

Time Frame

Through study completion, an average of 12 weeks

Secondary Outcome Measure Information:

Title

Changes in the Short Chain Fatty Acid Levels in the Gut.

Description

Measurement of Short Chain Fatty Acid Levels in the Stools.

Time Frame

Through study completion, an average of 12 weeks

Title

Changes in Glycemia.

Description

Time Frame

Through study completion, an average of 12 weeks

Title

Changes in Beta cell Health.

Description

Time Frame

Through study completion, an average of 12 weeks

Other Pre-specified Outcome Measures:

Title

Changes in frequency of Mucosal Associated invariant T (MAIT) cells

Description

We will compare changes in MAIT cell frequency before and after the interventions

Time Frame

Through study completion, an average of 12 weeks

Title

Changes in function of Mucosal Associated invariant T (MAIT) cells

Description

We will compare changes in MAIT cell function before and after the interventions

Time Frame

Through study completion, an average of 12 weeks

Title

Changes in phenotype of Mucosal Associated invariant T (MAIT) cells

Description

We will compare changes in MAIT cell phenotype before and after the interventions

Time Frame

Through study completion, an average of 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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)]. Exclusion Criteria: 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) 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 -

Facility Information:

Facility Name

Indiana University School of Medicine

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function

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