Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249074
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Brief Title:
Gluten-free Diet in Women With Autoimmune Thyroiditis
Sponsor:
Medical University of Gdansk
Organization:
Medical University of Gdansk
Study Overview
Official Title:
The Impact of Gluten-free Diet on the Thyroid Function Quality of Life and Gut Microbiome Composition in Women With Autoimmune Thyroiditis
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this interventional study was to check if the elimination of gluten from the diet of women with autoimmune thyroiditis affects their health and thyroid function quality of life and the gut microbiome composition
The main questions it aimed to answer were
Does the gluten-free diet worsen the gut microbiome composition
Does the gluten-free diet improve thyroid function measured as thyroid stimulating hormone TSH thyroid hormones thyroxine FT4 and triiodothyronine FT3 thyroid peroxidase antibodies TPOAb and thyroglobulin antibodies TgAb
Does the gluten-free diet improve the quality of life
Participants
followed normocaloric gluten-free diet for 8 weeks
after first 4 weeks were randomly assigned to one of two groups One group over next 4 weeks additionally to gluten-free diet received gluten in gastrosoluble capsules and second group - rice starch placebo
Blood and stool samples were collected before diet T0 after 4 weeks T1 and after 8 weeks of diet T2 total of 3 samples per participant Also each participant completed the ThyPROpl quality of life assessment questionnaire for patients with thyroid diseases in three time points before the diet T0 after 4 weeks T1 and after 8 weeks of the diet T2
The main questions it aimed to answer were
Does the gluten-free diet worsen the gut microbiome composition
Does the gluten-free diet improve thyroid function measured as thyroid stimulating hormone TSH thyroid hormones thyroxine FT4 and triiodothyronine FT3 thyroid peroxidase antibodies TPOAb and thyroglobulin antibodies TgAb
Does the gluten-free diet improve the quality of life
Participants
followed normocaloric gluten-free diet for 8 weeks
after first 4 weeks were randomly assigned to one of two groups One group over next 4 weeks additionally to gluten-free diet received gluten in gastrosoluble capsules and second group - rice starch placebo
Blood and stool samples were collected before diet T0 after 4 weeks T1 and after 8 weeks of diet T2 total of 3 samples per participant Also each participant completed the ThyPROpl quality of life assessment questionnaire for patients with thyroid diseases in three time points before the diet T0 after 4 weeks T1 and after 8 weeks of the diet T2
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None