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Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet

Primary Purpose

Type1diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gluten and Amylase Trypsin Inhibitors (ATI)-free diet
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type1diabetes focused on measuring Siblings

Eligibility Criteria

2 Years - 23 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Males and females 2-23 years of age
  2. Full-sibling of an individual with a clinical diagnosis of type 1 diabetes
  3. Treatment naïve of any immunomodulatory agent

Exclusion Criteria:

  1. Abnormal HbA1c, defined as ≥ 6%
  2. Previous or current use of a gluten-free diet
  3. Current diagnosis of celiac disease
  4. An elevated tissue transglutaminase IgA level (> 10 units/mL)
  5. Chronic (≥ 3 months duration) gastrointestinal disease or presence of gastrointestinal symptoms within the prior 6 weeks (e.g., abdominal pain, worsening constipation, diarrhea, or recurrent nausea +/- vomiting)
  6. Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids
  7. Use of any medications that affect glucose metabolism (e.g., metformin) or the immune system (e.g., use of any glucocorticoids (inhaled, intranasal, oral, intravenous) within the previous 3 months)
  8. Use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics)
  9. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

Sites / Locations

  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dietary intervention

Arm Description

Participants will be asked to remove food containing gluten and ATI from their diets for 4 weeks.

Outcomes

Primary Outcome Measures

Change in the plasma-induced transcriptional assay
Investigators will measure the participants overall immune inflammation and regulation by a plasma-induced transcriptional bioassay. The change in this bioassay will be determined for each subject and the entire group both before and after the dietary intervention. This bioassay informs the investigators of which genes may be positively or negatively impacted by this dietary change and whether the removal of gluten and amylase trypsin inhibitors (ATI) affects a participant's immune state.

Secondary Outcome Measures

Stool microbial composition
Stool samples will be collected both before and after the dietary intervention to determine if the removal of gluten and amylase trypsin inhibitors (ATI) from the diet affects the composition and density of the stool microbiota
Plasma microbial antigen detection
Microbial antigen levels in the plasma of participants will be assayed both before and after the dietary intervention. Systemic microbial antigens are a marker of intestinal permeability so this measure will tell the investigators if the removal of gluten and amylase trypsin inhibitors (ATI) affects the degree of intestinal permeability/leakiness.
Leukocyte analyses
The degree of responsiveness of participants leukocytes to stimulation with gluten and amylase trypsin inhibitors (ATI) will be measured in vitro both before and after the dietary intervention.

Full Information

First Posted
January 31, 2018
Last Updated
May 9, 2022
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT03443180
Brief Title
Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet
Official Title
Gluten and Amylase Trypsin Inhibitors (ATI) as Nutritional Contributors to Type 1 Diabetes Susceptibility
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
March 9, 2020 (Actual)
Study Completion Date
March 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Siblings of those with type 1 diabetes are at an increased risk of developing the disease themselves. Through prior research, the investigators have found that siblings as well as those with type 1 diabetes have a general level of inflammation in the body. The investigators are examining the role that diet plays in this level of inflammation by asking siblings of children with type 1 diabetes to go on a gluten and Amylase Trypsin Inhibitors (ATI)-free diet for 4 weeks. Blood and stool samples will be measured before the diet, after the diet is completed and again 4 weeks after participants resume their normal diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
Keywords
Siblings

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will receive a dietary intervention. They will be instructed and asked to follow a diet free of gluten and the protein amylase trypsin inhibitors (ATI), which is frequently found in gluten-containing foods, for four weeks. They will then be asked to resume their normal diet.
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary intervention
Arm Type
Other
Arm Description
Participants will be asked to remove food containing gluten and ATI from their diets for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Gluten and Amylase Trypsin Inhibitors (ATI)-free diet
Intervention Description
Participants will be asked to avoid foods containing gluten and ATI (a similar protein found in grains) for 4 weeks.
Primary Outcome Measure Information:
Title
Change in the plasma-induced transcriptional assay
Description
Investigators will measure the participants overall immune inflammation and regulation by a plasma-induced transcriptional bioassay. The change in this bioassay will be determined for each subject and the entire group both before and after the dietary intervention. This bioassay informs the investigators of which genes may be positively or negatively impacted by this dietary change and whether the removal of gluten and amylase trypsin inhibitors (ATI) affects a participant's immune state.
Time Frame
2 years (study duration)
Secondary Outcome Measure Information:
Title
Stool microbial composition
Description
Stool samples will be collected both before and after the dietary intervention to determine if the removal of gluten and amylase trypsin inhibitors (ATI) from the diet affects the composition and density of the stool microbiota
Time Frame
2 years (study duration)
Title
Plasma microbial antigen detection
Description
Microbial antigen levels in the plasma of participants will be assayed both before and after the dietary intervention. Systemic microbial antigens are a marker of intestinal permeability so this measure will tell the investigators if the removal of gluten and amylase trypsin inhibitors (ATI) affects the degree of intestinal permeability/leakiness.
Time Frame
2 years (study duration)
Title
Leukocyte analyses
Description
The degree of responsiveness of participants leukocytes to stimulation with gluten and amylase trypsin inhibitors (ATI) will be measured in vitro both before and after the dietary intervention.
Time Frame
2 years (study duration)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females 2-23 years of age Full-sibling of an individual with a clinical diagnosis of type 1 diabetes Treatment naïve of any immunomodulatory agent Exclusion Criteria: Abnormal HbA1c, defined as ≥ 6% Previous or current use of a gluten-free diet Current diagnosis of celiac disease An elevated tissue transglutaminase IgA level (> 10 units/mL) Chronic (≥ 3 months duration) gastrointestinal disease or presence of gastrointestinal symptoms within the prior 6 weeks (e.g., abdominal pain, worsening constipation, diarrhea, or recurrent nausea +/- vomiting) Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids Use of any medications that affect glucose metabolism (e.g., metformin) or the immune system (e.g., use of any glucocorticoids (inhaled, intranasal, oral, intravenous) within the previous 3 months) Use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics) Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet

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