Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2020-09-22
2021-11-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Gluten
Gluten group received gluten in gastrosoluble capsules - 2 g of gluten in 3 capsules daily for 4 weeks (week 5 to week 8).
Gluten-free diet
Diet with gluten elimination followed by all participants for 8 weeks
Gluten capsules supplementation
2 g of gluten given in 3 capsules daily for 4 weeks (week 5 to week 8)
Placebo
Placebo group received rice starch in gastrosoluble capsules - 3 capsules daily for 4 weeks (week 5 to week 8).
Gluten-free diet
Diet with gluten elimination followed by all participants for 8 weeks
Placebo capsules supplementation
Rice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8).
Interventions
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Gluten-free diet
Diet with gluten elimination followed by all participants for 8 weeks
Gluten capsules supplementation
2 g of gluten given in 3 capsules daily for 4 weeks (week 5 to week 8)
Placebo capsules supplementation
Rice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8).
Eligibility Criteria
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Inclusion Criteria
* stabilized thyroid function, i.e. thyroid hormones within normal range;
* BMI indicating correct body mass, i.e. within 18.5 - 24.9 kg/m\^2.
Exclusion Criteria
* concomitant celiac disease and / or wheat allergy;
* gluten-free diet followed during 6 months prior to enrollment;
* intestinal disorders;
* antibiotic or probiotic therapy during 6 months prior to enrollment.
20 Years
50 Years
FEMALE
No
Sponsors
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Nutricia Foundation
OTHER
Medical University of Gdansk
OTHER
Responsible Party
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Principal Investigators
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Aleksandra Rodziewicz, MSc
Role: PRINCIPAL_INVESTIGATOR
Medical University of Gdansk
Locations
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Medical University of Gdańsk
Gdansk, , Poland
Countries
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References
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Caturegli P, Kimura H, Rocchi R, Rose NR. Autoimmune thyroid diseases. Curr Opin Rheumatol. 2007 Jan;19(1):44-8. doi: 10.1097/BOR.0b013e3280113d1a.
McLeod DS, Cooper DS. The incidence and prevalence of thyroid autoimmunity. Endocrine. 2012 Oct;42(2):252-65. doi: 10.1007/s12020-012-9703-2. Epub 2012 May 29.
Vanderpump MP. The epidemiology of thyroid disease. Br Med Bull. 2011;99:39-51. doi: 10.1093/bmb/ldr030.
Proal AD, Albert PJ, Marshall TG. The human microbiome and autoimmunity. Curr Opin Rheumatol. 2013 Mar;25(2):234-40. doi: 10.1097/BOR.0b013e32835cedbf.
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De Filippis F, Pellegrini N, Vannini L, Jeffery IB, La Storia A, Laghi L, Serrazanetti DI, Di Cagno R, Ferrocino I, Lazzi C, Turroni S, Cocolin L, Brigidi P, Neviani E, Gobbetti M, O'Toole PW, Ercolini D. High-level adherence to a Mediterranean diet beneficially impacts the gut microbiota and associated metabolome. Gut. 2016 Nov;65(11):1812-1821. doi: 10.1136/gutjnl-2015-309957. Epub 2015 Sep 28.
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Di Sabatino A, Volta U, Salvatore C, Biancheri P, Caio G, De Giorgio R, Di Stefano M, Corazza GR. Small Amounts of Gluten in Subjects With Suspected Nonceliac Gluten Sensitivity: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial. Clin Gastroenterol Hepatol. 2015 Sep;13(9):1604-12.e3. doi: 10.1016/j.cgh.2015.01.029. Epub 2015 Feb 19.
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Other Identifiers
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RG 4/2020
Identifier Type: -
Identifier Source: org_study_id
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