Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000845134
Ethics application status
Approved
Date submitted
30/05/2019
Date registered
14/06/2019
Date last updated
14/06/2019
Date data sharing statement initially provided
14/06/2019
Date results provided
14/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating health effects of fibre consumption in healthy humans
Scientific title
Exploring the use of a high-fibre diet to alter short-chain fatty acids and immune markers in healthy humans: A pilot study
Secondary ID [1] 298364 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gut disease 313025 0
Asthma 313026 0
Inflammatory Bowel Disease 313098 0
Allergies 313099 0
Condition category
Condition code
Diet and Nutrition 311536 311536 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 311537 311537 0 0
Normal development and function of the immune system
Metabolic and Endocrine 311580 311580 0 0
Normal metabolism and endocrine development and function
Oral and Gastrointestinal 311581 311581 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study has a cross-over design in which participants are randomised to complete a intervention diet and control diet in random order. The intervention diet is a 5-day high-fibre dietary intervention provided in the form of meals to study participants. Participants are provided with 3 main meals day (breakfast, lunch, dinner) and 2 snack items a day (morning tea, afternoon tea). Participants may also eat other foods outside of the provided diet but are given a list of recommended snack foods to help them follow the intervention diet as best as possible. Meals have been developed with a dietitian to ensure they are nutritionally balanced and are cooked by a research chef in a commercial grade kitchen. Meals are portioned, vacuum-sealed and then provided to participants frozen. Participants are given study food diaries to follow and to help assess compliance. The average amount of energy provided by the study meals/snacks is 9277 kj/day. The average amount of total fibre is 39 g/day all of which is naturally contained in the foods provided. These are mainly in the form of resistant starch (7 g/day) and fermentable oligosaccharides (7 g/day). Meals for the high fibre diet high in legumes, wholegrains, fruits and vegetables. Example foods include Rye bread, wholegrain cereals (wheat bran), brown rice, split peas, pear and cannellini beans. These figures have been calculated through the use of food composition software (Foodworks).
Once completed, there is a 5-day wash-out period between the diets.
Intervention code [1] 314607 0
Treatment: Other
Comparator / control treatment
The study has a cross-over design in which participants are randomised to complete a intervention diet and control diet in random order.
The control diet is a 5-day low fibre diet provided in the form of meals to study participants. This provides an average of 18 g/day and has much lower levels of resistant starch (2 g/day vs 7 g/day) and oligosaccharides (1 g/day vs 7 g/day) compared to the high-fibre diet. This is achieved by making meals with refined grains and flours and low fermentable fibre fruits and vegetables (i.e strawberries, kiwifuit, lettuce, tomato). Participants are provided with 3 main meals day (breakfast, lunch, dinner) and 2 snack items a day (morning tea, afternoon tea). Participants may also eat other foods outside of the provided diet but are given a list of recommended snack foods to help them follow the intervention diet as best as possible. Meals have been developed with a dietitian to ensure they are nutritionally balanced and are cooked by a research chef in a commercial grade kitchen. Meals are portioned, vacuum-sealed and then provided to participants frozen by the study researcher.. Participants are given study food diaries to follow and to help assess compliance. The average amount of energy provided by the study meals/snacks is 9132 kj/day. This figure has been calculated through the use of food composition software (Foodworks).
Control group
Active

Outcomes
Primary outcome [1] 320238 0
Blood Short-chain fatty acid level
Timepoint [1] 320238 0
Morning of Day 5 of intervention and control diet
Secondary outcome [1] 370958 0
Proportion of peripheral blood T-regulatory cells
Timepoint [1] 370958 0
Morning of Day 5 of intervention and control diet
Secondary outcome [2] 370959 0
This is a composite secondary outcome measuring Blood cytokine levels.
Interleukin (IL)-10, IL-17A, IL-1B, IL-6, IL-8 and Tumour necrosis factor (TNF)-a
Measured by multiplex analysis
Timepoint [2] 370959 0
Morning of day 5 of intervention and control diet

Eligibility
Key inclusion criteria
Healthy adults
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inflammatory conditions (i.e asthma, inflammatory bowel disease, rheumatoid arthritis, allergy)
Recent bacterial or viral infection (<4 weeks)
Current or recent (<4 weeks) use of probiotics, antibiotics or medications that potentially alter normal gut function
Pregnancy or current breastfeeding
Special dietary requirements (i.e. allergy, vegetarian, vegan)

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/07/2015
Date of last participant enrolment
Anticipated
Actual
11/08/2015
Date of last data collection
Anticipated
Actual
10/09/2015
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302903 0
University
Name [1] 302903 0
Monash University
Country [1] 302903 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Gastroenterology, Central clinical school, Level 6, The Alfred centre, 99 Commercial road, Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 302861 0
None
Name [1] 302861 0
Address [1] 302861 0
Country [1] 302861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303476 0
Monash University Human Research Ethics Commitee
Ethics committee address [1] 303476 0
Ethics committee country [1] 303476 0
Australia
Date submitted for ethics approval [1] 303476 0
Approval date [1] 303476 0
27/05/2015
Ethics approval number [1] 303476 0

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

Contacts
Principal investigator
Name 93782 0
A/Prof Jane Muir
Address 93782 0
Department of Gastroenterology, Monash University, Level 6, The Alfred centre, 99 Commercial Road, Melbourne, Victoria 3004
Country 93782 0
Australia
Phone 93782 0
+61 3 99030274
Fax 93782 0
Email 93782 0
[email protected]
Contact person for public queries
Name 93783 0
Paul Gill
Address 93783 0
Department of Gastroenterology, Monash University, Level 6, The Alfred centre, 99 Commercial Road, Melbourne, Victoria 3004
Country 93783 0
Australia
Phone 93783 0
+61 3 99030396
Fax 93783 0
Email 93783 0
[email protected]
Contact person for scientific queries
Name 93784 0
Paul Gill
Address 93784 0
Department of Gastroenterology, Monash University, Level 6, The Alfred centre, 99 Commercial Road, Melbourne, Victoria 3004
Country 93784 0
Australia
Phone 93784 0
+61 3 99030396
Fax 93784 0
Email 93784 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD sharing was not included in approved ethics obtained from Monash University Human research ethics committee.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.