None listed
Conditions
Brief summary
The purpose of this study is to examine the effect of gluten on gastrointestinal symptoms and mental health in those with NCGS. It is hypothesised that a major effect of gluten in those with NCGS is on mental health and not necessarily on GI symptoms.
Interventions
Participants receive one of three dietary challenges consecutively for 3 days, followed by a minimum 3-day washout before crossing over to the next diet. Challenge food is supplemented with gluten (16g/day whole wheat gluten), whey (16g/day whey protein isolate) or not supplemented (control). All meals and snacks are supplied throughout the duration of the study and controlled for other potential inducers of symptoms (FODMAPs, dairy, food chemicals).
Dietary adherence will be assessed by entri
Participants receive one of three dietary challenges consecutively for 3 days, followed by a minimum 3-day washout before crossing over to the next diet. Challenge food is supplemented with gluten (16g/day whole wheat gluten), whey (16g/day whey protein isolate) or not supplemented (control). All meals and snacks are supplied throughout the duration of the study and controlled for other potential inducers of symptoms (FODMAPs, dairy, food chemicals). Dietary adherence will be assessed by entries into a tick-box diary and unused food is counted at the end of each dietary challenge. Participants are asked to document any additional foods consumed.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged >16 years of age, met Rome III criteria for IBS prior to implementation of a GFD, had currently well controlled gastrointestinal symptoms, and had been adherent to a GFD for at least the preceding six weeks. Celiac disease was excluded by either a normal duodenal biopsy (Marsh 0) performed at endoscopy while on a gluten containing diet and/or by the absence of the HLA-DQ2 and HLA-DQ8 haplotype.
Exclusion criteria
Other significant gastrointestinal disease (such as cirrhosis or inflammatory bowel disease); other clinically significant co-morbidity; intake of non-steroidal anti-inflammatory agents; use of systemic immunosuppressant medication; poorly controlled psychiatric disease; excessive alcohol intake; pregnancy; or inability to give written informed consent.
Outcome results
None listed