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Trial registered on ANZCTR


Registration number
ACTRN12616000766415
Ethics application status
Approved
Date submitted
7/06/2016
Date registered
10/06/2016
Date last updated
10/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Minimising the impact of high fructose foods for patients with Irritable Bowel Syndrome: investigating the use of added glucose to assist with fructose absorption from food by the small intestine in healthy volunteers and in patients with IBS
Scientific title
Minimising the impact of high fructose foods for patients with Irritable Bowel Syndrome: investigating the use of added glucose to assist with fructose absorption from food by the small intestine in healthy volunteers and in patients with IBS
Secondary ID [1] 289385 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable bowel syndrome 299029 0
Condition category
Condition code
Oral and Gastrointestinal 299085 299085 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This was a randomised, single-blind crossover trial using whole foods as the source of fructose with and without added glucose. During a 36-h low FODMAP (Fermentable, Oligosaccharides, Disacchardies, Monosaccharides and Polyols) run-in period, followed by a 24-h test day, all food was provided. Breath hydrogen samples were collected hourly for 14 h on two consecutive days, commencing before breakfast each day. For the test day, participants were randomised to either a diet high in fructose with no added glucose (high fructose diet), or high in fructose with glucose added to give a 1:1 ratio of free fructose to free glucose (fructose/glucose co-administration diet). Following a one-week washout period, participants crossed over to the alternative diet. For both test diets, foods included were naturally high in fructose in excess of glucose (including watermelon, apple/guava juice, pear and apple muffins). The remainder of the diet was low in total FODMAP content.

For the fructose/glucose co-administration diet, glucose was co-ingested by participants in tablet form (Glucodin tablets; Reckitt Benckiser, NSW Australia) when whole pieces of fruit were eaten. Participants were asked to consume the glucose tablets at the time of meal consumption. Glucose powder (Glucodin Powder; Reckitt Benckiser, NSW Australia) was added during the baking process for apple muffins and pre-mixed with apple/guava juice. For the high fructose diet, sucrose cubes and powder replaced the glucose to aid in blinding the participants.

The high fructose foods provided 11 g of fructose in excess of glucose. The diets provided during the two run-in periods were identical. The two high excess-fructose diets were also identical apart from the addition of sucrose and/or glucose. There were no differences in macronutrient content between the two test diets including total carbohydrate, starch, dietary fibre and total sugar levels.

The provided diet on the test day is listed below:
† denotes high fructose foods
Energy intake was not individualised, it was a standard amount, the same given to each participant. Total energy provided was 9.5MJ/day.

Breakfast: Corn flakes (30 g), Milk (LF), Bread 2 slices (GF), Butter/margarine, Vegemite, † 1 slice fresh Watermelon (plus 1 *glucose tablet), †Apple-guava Juice (200ml + 1.5 g *glucose powder)
Morning tea: † 1 fresh Pear (plus 6 *glucose tablets), Sweet biscuit (GF)
Lunch: Chicken pasta bake, † Apple-guava Juice (200ml + 1.5 g glucose)
Afternoon tea: † Apple muffin (GF + 0.1 g glucose)
Dinner: Lasagne (GF)
Supper: Drinking chocolate

Note: Each glucose tablet contains 1.5g glucose.

Participants completed food diaries to monitor compliance.

Participants consume all meals at home at their own convenience. It was up to the participant as to what time of day each meal and snack was consumed.
Intervention code [1] 294972 0
Treatment: Other
Comparator / control treatment
A healthy control group without symptoms of irritable syndrome were also recruited.
Control group
Active

Outcomes
Primary outcome [1] 298552 0
Breath hydrogen testing

The breath hydrogen testing will measure the amount of carbohydrate which is not absorbed in the small intestine and hence travels to the large intestine and is fermented by the colonic bacteria. Therefore it will measure if the glucose is able to improve small intestinal absorption and subsequently reduce fermentation in the large bowel (measured via amount of breath hydrogen production).

The outcome is therefore how much breath hydrogen is produced, which gives us a indirect measure of the amount of small intestinal fructose absorption.
Timepoint [1] 298552 0
Area under the curve of samples taken hourly for 14 hours

Breath hydrogen testing occurs from prior to breakfast consumption on each day and then a sample is taken on an hourly basis for the following 14 hours. The 14 hour testing occurs on the day before the test day (run-in) and also on the test day.

E.g. if the participant ate Breakfast at 7am, they would complete their first sample at 7am and take samples hourly until 9pm.
Primary outcome [2] 298553 0
Overall symptom score.

Participants are asked to score how their gastrointestinal symptoms were overall from 0-100 (no symptoms at all to worst ever symptoms) on a 100mm visual analogue scale (VAS).

They rate their symptoms at bedtime for how they felt for the day.

This is for the 'overall symptom score' i.e. how they felt their IBS symptoms were overall that day. (Below in the secondary outcomes are the other questions for specific symptom types).
Timepoint [2] 298553 0
Measured daily at the end of each day on a validated 100 mm visual analogue scale (VAS).
Symptoms were measured at bedtime on both the run-in (end of the run-in period) as well as the end of the 24 hour test day.
The run-in period also included the evening meal the night before (i.e. 2 days before the test day), but symptoms were not measured this day.
Secondary outcome [1] 324566 0
Abdominal pain - measured on 100mm VAS
Timepoint [1] 324566 0
Measured daily at the end of each day on a validated 100 mm visual analogue scale (VAS).
Symptoms were measured at bedtime on both the run-in (end of the run-in period) as well as the end of the 24 hour test day.
Secondary outcome [2] 324596 0
Bloating - measured on 100mm VAS
Timepoint [2] 324596 0
Measured daily at the end of each day on a validated 100 mm visual analogue scale (VAS).
Symptoms were measured at bedtime on both the run-in (end of the run-in period) as well as the end of the 24 hour test day.
Secondary outcome [3] 324597 0
Wind - measured on 100mm VAS
Timepoint [3] 324597 0
Measured daily at the end of each day on a validated 100 mm visual analogue scale (VAS).
Symptoms were measured at bedtime on both the run-in (end of the run-in period) as well as the end of the 24 hour test day.
Secondary outcome [4] 324598 0
Nausea - measured on 100mm VAS
Timepoint [4] 324598 0
Measured daily at the end of each day on a validated 100 mm visual analogue scale (VAS).
Symptoms were measured at bedtime on both the run-in (end of the run-in period) as well as the end of the 24 hour test day.
Secondary outcome [5] 324599 0
Lethargy - measured on 100mm VAS
Timepoint [5] 324599 0
Measured daily at the end of each day on a validated 100 mm visual analogue scale (VAS).
Symptoms were measured at bedtime on both the run-in (end of the run-in period) as well as the end of the 24 hour test day.

Eligibility
Key inclusion criteria
Inclusion criteria required participants to be aged 18-70 years, and, within the past 3 months, to have fructose malabsorption identified by breath hydrogen rise of >15 ppm after 35 g fructose. Two groups of fructose malabsorbers were recruited: healthy subjects (without gastrointestinal symptoms) and patients with FBD, as determined by a gastroenterologist using the Rome III criteria. Those who expressed interest but had a positive fructose breath test more than 3 months prior were asked to repeat the fructose breath test prior to enrolment and only if fructose malabsorption was retained were they then invited to enrol.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria included inadequate breath hydrogen production (<15 ppm) after 35 g fructose, pregnancy or breastfeeding, diabetes, other gastrointestinal disorders such as coeliac disease, antibiotic or probiotic use in the past 2 weeks, and the taking of colonoscopy preparations in the past 4 weeks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
1/03/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293773 0
University
Name [1] 293773 0
Monash University
Country [1] 293773 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd & Blackburn Rd,
Clayton
VIC 3800
Australia
Country
Australia
Secondary sponsor category [1] 292601 0
None
Name [1] 292601 0
None
Address [1] 292601 0
None
Country [1] 292601 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295201 0
Deakin University Human Research Committee
Ethics committee address [1] 295201 0
Ethics committee country [1] 295201 0
Australia
Date submitted for ethics approval [1] 295201 0
20/03/2008
Approval date [1] 295201 0
27/03/2008
Ethics approval number [1] 295201 0
EC 37-2008

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66490 0
Ms Caroline Tuck
Address 66490 0
Monash University
Level 6, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 66490 0
Australia
Phone 66490 0
+61399030264
Fax 66490 0
Email 66490 0
[email protected]
Contact person for public queries
Name 66491 0
Caroline Tuck
Address 66491 0
Monash University
Level 6, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 66491 0
Australia
Phone 66491 0
+61399030264
Fax 66491 0
Email 66491 0
[email protected]
Contact person for scientific queries
Name 66492 0
Caroline Tuck
Address 66492 0
Monash University
Level 6, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 66492 0
Australia
Phone 66492 0
+61399030264
Fax 66492 0
Email 66492 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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