The effect of gluten in adolescents and young adults with gastrointestinal symptoms: a blinded randomised cross-over trial.
gluten
gluten sensitivity enteropathy
gluten-free diet
Journal
Alimentary pharmacology & therapeutics
ISSN: 1365-2036
Titre abrégé: Aliment Pharmacol Ther
Pays: England
ID NLM: 8707234
Informations de publication
Date de publication:
05 2022
05 2022
Historique:
revised:
17
09
2021
received:
19
08
2021
accepted:
20
03
2022
pubmed:
31
3
2022
medline:
20
4
2022
entrez:
30
3
2022
Statut:
ppublish
Résumé
The popularity of the gluten-free diet and sales of gluten-free products have increased immensely. To investigate whether gluten induces gastrointestinal symptoms, measured by self-reported questionnaires, as well as mental health symptoms in adolescents from a population-based cohort. The eligible participants (n = 273) were recruited from a population-based cohort of 1266 adolescents and had at least four different gastrointestinal symptoms. Phase one (n = 54) was a run-in phase where the participants lived gluten-free for 2 weeks. If they improved they continued to phase 2 (n = 33), a blinded randomised cross-over trial. Participants were blindly randomised either to start with 7 days of gluten, eating two granola bars containing 10 g of gluten or to 7 days on placebo, eating two granola bars without gluten, followed by the reverse and separated by a 7-day washout period. The effects of the intervention on gastrointestinal symptoms and mental health symptoms were assessed. In total, 54/273 participants entered the run-in phase and 35 were eligible for randomization. A total of 33 were randomised and 32 completed the trial. The median age was 20.3 (IQR 19.2-20.9) and 32/33 participants were females. Compared with a placebo, gluten did not induce gastrointestinal symptoms. The difference in the average VAS was -0.01 (95% confidence interval -2.07 to 2.05). Nor did we find a difference in the outcomes measuring mental health. Compared with placebo, adding gluten to the diet did not induce gastrointestinal symptoms or worsened mental health in adolescents recruited from a population-based cohort. The trial registration number is NCT04639921.
Sections du résumé
BACKGROUND
The popularity of the gluten-free diet and sales of gluten-free products have increased immensely.
AIMS
To investigate whether gluten induces gastrointestinal symptoms, measured by self-reported questionnaires, as well as mental health symptoms in adolescents from a population-based cohort.
METHODS
The eligible participants (n = 273) were recruited from a population-based cohort of 1266 adolescents and had at least four different gastrointestinal symptoms. Phase one (n = 54) was a run-in phase where the participants lived gluten-free for 2 weeks. If they improved they continued to phase 2 (n = 33), a blinded randomised cross-over trial. Participants were blindly randomised either to start with 7 days of gluten, eating two granola bars containing 10 g of gluten or to 7 days on placebo, eating two granola bars without gluten, followed by the reverse and separated by a 7-day washout period. The effects of the intervention on gastrointestinal symptoms and mental health symptoms were assessed.
RESULTS
In total, 54/273 participants entered the run-in phase and 35 were eligible for randomization. A total of 33 were randomised and 32 completed the trial. The median age was 20.3 (IQR 19.2-20.9) and 32/33 participants were females. Compared with a placebo, gluten did not induce gastrointestinal symptoms. The difference in the average VAS was -0.01 (95% confidence interval -2.07 to 2.05). Nor did we find a difference in the outcomes measuring mental health.
CONCLUSION
Compared with placebo, adding gluten to the diet did not induce gastrointestinal symptoms or worsened mental health in adolescents recruited from a population-based cohort. The trial registration number is NCT04639921.
Identifiants
pubmed: 35352373
doi: 10.1111/apt.16914
pmc: PMC9313792
doi:
Substances chimiques
Glutens
8002-80-0
Banques de données
ClinicalTrials.gov
['NCT04639921']
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1116-1127Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.
Références
Neurogastroenterol Motil. 2018 Mar 15;:
pubmed: 29542844
Nutrients. 2021 Jan 27;13(2):
pubmed: 33513886
Nutrients. 2017 Jul 19;9(7):
pubmed: 28753927
Nutrients. 2016 Feb 08;8(2):84
pubmed: 26867199
BMJ. 2019 Jul 31;366:l4378
pubmed: 31366597
Clin Gastroenterol Hepatol. 2021 Nov;19(11):2343-2352.e8
pubmed: 32827724
Nutrients. 2015 Jun 18;7(6):4966-77
pubmed: 26096570
J Clin Epidemiol. 1998 Nov;51(11):1001-11
pubmed: 9817118
Nutrients. 2020 Feb 15;12(2):
pubmed: 32075276
Gastroenterology. 2019 Jun;156(8):2266-2280
pubmed: 30802444
Nutrition. 2021 Jan;81:110944
pubmed: 33053456
Nutrients. 2020 Mar 06;12(3):
pubmed: 32155878
Appetite. 2021 Jan 1;156:104958
pubmed: 32919023
BMC Med. 2014 May 23;12:85
pubmed: 24885375
Med J Aust. 2020 Feb;212(3):126-131
pubmed: 31909482
J Hum Nutr Diet. 2013 Aug;26(4):349-58
pubmed: 23198728
Nat Commun. 2018 Nov 13;9(1):4630
pubmed: 30425247
Nutrients. 2020 Jun 30;12(7):
pubmed: 32629906
Clin Gastroenterol Hepatol. 2016 May;14(5):696-703.e1
pubmed: 26748221
Gastroenterology. 2013 Aug;145(2):320-8.e1-3
pubmed: 23648697
Am J Clin Nutr. 2021 Mar 11;113(3):622-629
pubmed: 33184625
Clin Gastroenterol Hepatol. 2015 Sep;13(9):1604-12.e3
pubmed: 25701700
Eur J Nutr. 2017 Feb;56(1):107-117
pubmed: 26437832
Aliment Pharmacol Ther. 2015 Oct;42(8):968-76
pubmed: 26310131
Nutrients. 2020 Mar 28;12(4):
pubmed: 32231050
Sci Rep. 2020 Feb 12;10(1):2401
pubmed: 32051513
J Hum Nutr Diet. 2019 Jun;32(3):311-320
pubmed: 30834587
Scand J Public Health. 2001 Dec;29(4):300-7
pubmed: 11775787
Nutrients. 2017 Jan 21;9(1):
pubmed: 28117706
Gastroenterology. 2018 Feb;154(3):529-539.e2
pubmed: 29102613
United European Gastroenterol J. 2018 Jul;6(6):866-878
pubmed: 30023064
Br J Nutr. 2019 Jul 28;122(2):231-239
pubmed: 31232248
Am J Gastroenterol. 2018 Mar;113(3):421-430
pubmed: 29380821
Acta Paediatr. 2014 Feb;103(2):214-24
pubmed: 24127859
Clin Gastroenterol Hepatol. 2017 Mar;15(3):339-348
pubmed: 27523634
Clin Gastroenterol Hepatol. 2020 Aug;18(9):1913-1922.e1
pubmed: 30978535
PeerJ. 2020 Jul 27;8:e9590
pubmed: 33194333
Med Care. 1992 Jun;30(6):473-83
pubmed: 1593914
Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907
pubmed: 22825366
Nutrients. 2016 Nov 08;8(11):
pubmed: 27834802
BMJ. 2011 Feb 07;342:d40
pubmed: 21300711
J Pediatr. 2014 Mar;164(3):463-7.e1
pubmed: 24252792
Aliment Pharmacol Ther. 2022 May;55(9):1116-1127
pubmed: 35352373
Am J Gastroenterol. 2006 Oct;101(10):2356-9
pubmed: 17032202
J Biomed Inform. 2019 Jul;95:103208
pubmed: 31078660
Health Qual Life Outcomes. 2007 Nov 27;5:63
pubmed: 18042300
N Engl J Med. 2020 Feb 6;382(6):554-561
pubmed: 32023375
Am J Gastroenterol. 2021 Jan 1;116(1):17-44
pubmed: 33315591
Nutrients. 2015 Jul 21;7(7):6000-15
pubmed: 26197336