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

NCT ID: NCT04114357

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-22
• Study Completion Date: 2023-06-09

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Supplement Intervention and Control Diet, then Control Diet Alone

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.

Group Type: EXPERIMENTAL

Acetylated and Butyrylated High Amylose Maize Starch

Intervention Type: DRUG

Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner for 4 weeks

Control Diet Alone, then Supplement Intervention and Control Diet

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acetylated and Butyrylated High Amylose Maize Starch

Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner for 4 weeks

Intervention Type: DRUG

Other Intervention Names

Hylon™ VII Butyrate, Hylon™ VII Acetate

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

1. 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.

2. Diabetes other than T1D (Known monogenic forms of diabetes, Type 2 diabetes)

3. 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)

4. Psychiatric impairment or current use of anti-psychotic medication

5. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.

6. 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)

7. History of recurrent infections

8. History of on-going infections or antibiotic treatment within the past three months

9. History of immune compromise

10. Steroid intake (inhaled or oral)

11. Other immunosuppressant use in past 6 months

12. History of gastrointestinal disease

13. Possible or confirmed celiac disease

14. Pregnancy or possible pregnancy

15. Allergy to corn (prebiotic)

16. Allergy to milk or milk products or soy present in Boost

17. Participation in other intervention research trials within the past 3 months

18. Anticipate major changes in diabetes management during study (change from injection to pump, new start of continuous glucose monitoring)

19. 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).

20. Taking fiber supplements

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• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Heba M. Ismail

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana University School of Medicine

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37626387 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

KL2TR002530

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UL1TR002529

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1907172784

Identifier Type: -

Identifier Source: org_study_id