ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001054202

Ethics application status

Approved

Date submitted

15/06/2018

Date registered

25/06/2018

Date last updated

15/11/2019

Date data sharing statement initially provided

5/06/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Studying health effects of consumption of a high fibre diet in healthy humans

Scientific title

Study of immune and therapeutic effects of short-chain fatty acids in humans given a high fibre diet.

Secondary ID [1]

NONE

Universal Trial Number (UTN)

Trial acronym

SITES

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hypertension

Gut disease

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Inflammatory and Immune System

Normal development and function of the immune system

Cardiovascular

Hypertension

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

3 week dietary intervention provided in the form of meals and supplements 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 8400 kj/day as to ensure all intervention meals are consumed. The average amount of fibre is 40 g/day. 20 g of which is from the foods provided, 10 g from Resistant starch added to certain meals and 10 g from Inulin also added to certain meals. These fibres are mixed into meals during the cooking process. These figures have been calculated through the use of food composition software (Foodworks).
Examples of meals that have resistant starch fibre added to them include breakfast pancakes, muffins and Tuna and vegetable patties. Some meals will also have a fermentable fibre (inulin) added to them such as risotto, pasta sauce and curry.

Intervention code [1]

Lifestyle

Comparator / control treatment

A 3-week low fibre diet. This will deliver 20 g/day of dietary fibre on on the low fibre diet.
3 week dietary intervention provided in the form of meals to study participants. No additional supplements are provided. 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 8400 kj/day as to ensure all intervention meals are consumed. This figure has been calculated through the use of food composition software (Foodworks).
Examples of meals (all made with gluten-free/low flour) include breakfast pancakes, muffins and Tuna and vegetable patties

Control group

Dose comparison

Outcomes

Primary outcome [1]

Blood short-chain fatty acid level

Timepoint [1]

Day 21 of dietary intervention period

Primary outcome [2]

Peripheral blood immune cells assessed by flow cyotmetry. Absolute numbers of the following cells will be assessed:
T cells: Th2, Th1, Th17, Treg subsets
B cells: IgA+, IgG+, IgE+
Innate immune cells: Dendritic cells, neutrophils, macrophages

This is a composite primary outcome.

Timepoint [2]

Day 21 of dietary intervention period

Primary outcome [3]

Faecal microbiota composition as assessed by 16S rRNA sequencing. This is an exploratory outcome

Timepoint [3]

Day 20 of dietary intervention period

Secondary outcome [1]

Blood pressure, measured by a digital blood pressure monitor.

Timepoint [1]

24 hours during day 20 of dietary intervention period

Secondary outcome [2]

Gastrointestinal symptoms. Participants will complete bowel symptom diaries to assess abdominal bloating, bowel movements, urgency of bowel movements, wind and nausea. These are measured using VAS scales. Stool form will also be assessed using the bristol stool scale.
Together, this is a composite primary outcome.

Timepoint [2]

Everyday throughout dietary intervention period

Eligibility

Key inclusion criteria

Healthy adults

Minimum age

18 Years

Maximum age

45 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Existing or history of gastrointestinal or chronic inflammatory disease; recent acute illness or infection; antibiotic use within one month of study; consumption of probiotics or prebiotics within one month of study; use of medication gastrointestinal transit (e.g. laxatives or hypomotility agents); pregnant or planning pregnancy; suffering from an eating disorder; have special dietary requirements (vegetarian/vegan) or currently taking medication for hypertension.

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

28/06/2018

Actual

23/08/2018

Date of last participant enrolment

Anticipated

29/06/2019

Actual

25/06/2019

Date of last data collection

Anticipated

14/09/2019

Actual

9/09/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment postcode(s) [1]

3004 - Prahran

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Department of Gastroenterology, Central clinical school, Level 6, The Alfred centre, 99 Commercial road, Melbourne, Victoria 3004

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Commitee

Ethics committee address [1]

Monash Research Office,  26 Sports Walk, Monash University, Wellington Road, Clayton VIC 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/01/2018

Approval date [1]

01/03/2018

Ethics approval number [1]

11190

Summary

Brief summary

Dietary fibre is important for gut health. Within the large intestine, some dietary fibres are broken down by the gut bacteria (microbiota) in a process called fermentation. A product of fermentation are metabolites called short-chain fatty acids. These can also be found in fermented foods and drinks, such as vinegar. In animal studies, short-chain fatty acids have been associated with reduced inflammation and lower blood pressure.
The aims of this research project is to investigate if increasing short-chain fatty acids through increasing fibre and fermentable foods in the diet have effects on:
1. Immune cells and inflammation
2. Blood pressure
3. Gut function
To answer these questions, we are asking for healthy volunteers to participate in a dietary intervention study. This will involve consuming a diet with varying levels of fibre and fermented foods. At certain points in the study, Blood and faecal samples will be taken and we will also measure your blood pressure. We aim to recruit 30 healthy participants.
This study will help us to understand if dietary fibre and fermentable foods could be used to reduce inflammation and blood pressure in conditions such as asthma, allergy and hypertension in the future. This study has been initiated by A/Prof. Jane Muir, head of Translational research at the Department of Gastroenterology and is being conducted by Mr. Paul Gill as part of his PhD studies

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Jane Muir

Address

Department of Gastroenterology, Monash University, Level 6, The Alfred centre, 99 Commercial Road, Melbourne, Victoria 3004

Country

Australia

Phone

+61 3 99030274

Fax

jane.muir@monash.edu

Contact person for public queries

Name

Paul Gill

Address

Department of Gastroenterology, Monash University, Level 6, The Alfred centre, 99 Commercial Road, Melbourne, Victoria 3004

Country

Australia

Phone

+61 3 99030396

Fax

paul.gill@monash.edu

Contact person for scientific queries

Name

Paul Gill

Address

Department of Gastroenterology, Monash University, Level 6, The Alfred centre, 99 Commercial Road, Melbourne, Victoria 3004

Country

Australia

Phone

+61 3 99030396

Fax

paul.gill@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

We have not obtained ethics approval for individual participant data to be made public. At this stage we do not intend on making this data public.

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

Source	Title	Year of Publication	DOI
Embase	A randomized dietary intervention to increase colonic and peripheral blood SCFAs modulates the blood B- and T-cell compartments in healthy humans.	2022	https://dx.doi.org/10.1093/ajcn/nqac246

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically