Role of naturally occurring dietary salicylates in Irritable Bowel Syndrome
Monash UniversityDataset description
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.
Date Information
Identifiers
Source Study
Trial name (public)
Purpose:
Phase:
Trial acronym
Trial ID
ACTRN12620001250921
Funding
University, Monash University
Scientific enquiries
Dr Caroline Tuck
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 trig .... Read more
Key Inclusion Criteria
Patients with irritable bowel syndrome based on Rome III criteria.
Key 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.
Can healthy volunteers participate?
No
Population
Sample Size 10
Min. age 18 Years
Max. age 75 Years
Sex Both males and females
Condition category Irritable bowel syndrome
Condition code Oral and Gastrointestinal
Intervention
Intervention code Treatment: Other
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 investiga .... Read more
Comparison
Control group Active
Comparator diet: High salicylate diet The average daily intake of salicylates in the high-salicylate diet was 28 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.
Outcomes
Outcome: The primary endpoint was the difference in overall gastrointestinal symptoms measured by the 100-mm Visual Analogue Scale on the low-salicylate diet compared to those on the high-salicylate diet. Timepoint: All comparisons were made using average symptom scores of the last three days of the respective dietary periods.
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
On request on a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
For IPD meta-analyses