Data

Role of naturally occurring dietary salicylates in Irritable Bowel Syndrome

Monash University

Dataset 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.
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Source Study

Trial acronym

Not available

Trial ID

ACTRN12620001250921

Purpose

Treatment

Phase

Not Applicable

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 ....
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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 ....
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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.

Study Protocol: Not Available
Data Dictionary: Not Available

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

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au