Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet

NCT03443180 | Completed

• 1 other identifier: 1138159
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes

Keywords

Siblings

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years (study duration)

Secondary Outcomes (3)

• Stool microbial composition

  2 years (study duration)

• Plasma microbial antigen detection

  2 years (study duration)

• Leukocyte analyses

  2 years (study duration)

Study Arms (1)

Dietary intervention

OTHER

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

Other: Gluten and Amylase Trypsin Inhibitors (ATI)-free diet

Interventions

Gluten and Amylase Trypsin Inhibitors (ATI)-free diet OTHER

Participants will be asked to avoid foods containing gluten and ATI (a similar protein found in grains) for 4 weeks.

Dietary intervention

Eligibility Criteria

• Age: 2 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Interventions

Glutens

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 23, 2018
• Study Start: January 1, 2018
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)