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Role of naturally occurring dietary salicylates in Irritable Bowel Syndrome

Role of naturally occurring dietary salicylates in Irritable Bowel Syndrome: Investigating impact on gastrointestinal symptoms

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001250921
Enrollment
10
Registered
2020-11-20
Start date
2014-07-22
Completion date
2015-05-31
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

An therapeutic diet targeting naturally-occurring bioactive chemicals has been suggested to relieve gastrointestinal symptoms. A major focus of this diet is salicylates. This study aimed to address a potential role of dietary salicylates in causing symptoms in patients with irritable bowel syndrome (IBS). A pilot, double-blind, randomised, cross-over trial of two-week low-versus high-salicylate diets was undertaken. All food was provided containing minimal quantities of other potential food triggers. Gastrointestinal and extra-intestinal symptoms were measured daily using a 100-mm visual-analogue-scale. We hypothesised that a low salicylate diet would improve symptoms compared to the high salicylate diet in the 10 patients with IBS who conducted the study.

Interventions

Brief name: Low salicylate diet Comparator diet: High salicylate diet (see below) Overall design: This was a pilot, double-blind, randomised, cross-over trial of low versus high-salicylate diets in IBS patients who had no previous exposure to a low chemical diet. Materials: Participants were randomized by a computer-generated order to receive a diet either low or high in salicylate content for 14-days (6.6 and 27.9 g/day salicylate respectively). All food was provided. Participants and invest

Brief name: Low salicylate diet Comparator diet: High salicylate diet (see below) Overall design: This was a pilot, double-blind, randomised, cross-over trial of low versus high-salicylate diets in IBS patients who had no previous exposure to a low chemical diet. Materials: Participants were randomized by a computer-generated order to receive a diet either low or high in salicylate content for 14-days (6.6 and 27.9 g/day salicylate respectively). All food was provided. Participants and investigators were blinded to the diet. After the initial 14-days, the participants undertook a washout period of 7 days, where they resumed their habitual diet. No food was provided during this phase. During the washout phase, they completed a diary recording their symptoms and the amount and type of food they ate. This was followed by a cross-over to the alternate diet for further 14 days. During the interventional dietary phases, all participants were provided with food and they completed information on the quantity of the provided foods consumed. Interventional diets: All foods including three main meals, morning and afternoon snacks, and drinks were provided. Detailed meal plans for high- and low-salicylate diets were provided to the participants. For some meals that included fresh salads, detailed recipes were provided for participants to prepare before consumption. They were strictly instructed to avoid eating out during the course of the study. If participants wanted to eat foods that were not specified on the supplied list, they contacted the study investigator for guidance on food choices. Who provided intervention delivery & mode of delivery: The study investigator and two professional chefs prepared all foods in the commercial kitchen of Department of Dietetics, Monash University. Frozen complete meals were provided to the participants with instructions to thaw and heat before consumption. The foods were delivered bi-weekly free of charge to the participant homes. The diets were designed based upon the salicylate content of foods. Both diets were free of gluten, preservatives, additives and lactose, were consistent in their levels of minimal FODMAPs (fermentable oligo- di- mono-saccharides and polyols), and contained moderate levels of amines and glutamates as per published food content to avoid any confounding factors that might affect the symptoms. The average daily intake of salicylates in the low-salicylate diet was approximately 6 mg. The meal plans had an average energy value of 8 MJ daily and met the recommended serves of all food groups according to the Australian dietary guidelines. Location: The intervention occurred within the participants home. Personalisation: The intervention was not personalised to each patient. Adherence: Compliance was monitored via the daily food diaries.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Patients with irritable bowel syndrome based on Rome III criteria.

Exclusion criteria

- coeliac disease - pregnancy and breastfeeding, - other significant co-morbid conditions such as diabetes and inflammatory bowel disease. - previously received advice or information on a low chemical diet. - taking pharmacological agents like laxatives to alter their symptoms. - taking aspirin or any other drugs containing or delivering salicylates for at least two weeks prior to the commencement of the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 14, 2026