Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet
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|ClinicalTrials.gov Identifier: NCT03443180|
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : October 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type1diabetes||Other: Gluten and Amylase Trypsin Inhibitors (ATI)-free diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Gluten and Amylase Trypsin Inhibitors (ATI) as Nutritional Contributors to Type 1 Diabetes Susceptibility|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2022|
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
Participants will be asked to avoid foods containing gluten and ATI (a similar protein found in grains) for 4 weeks.
- Change in the plasma-induced transcriptional assay [ Time Frame: 2 years (study duration) ]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.
- Stool microbial composition [ Time Frame: 2 years (study duration) ]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 [ Time Frame: 2 years (study duration) ]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 [ Time Frame: 2 years (study duration) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443180
|Contact: Susanne Cabrera, MDemail@example.com|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Susanne Cabrera, MD 414-955-4903 firstname.lastname@example.org|