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Trial registered on ANZCTR

Registration number

ACTRN12609000306213

Ethics application status

Approved

Date submitted

17/05/2009

Date registered

19/05/2009

Date last updated

14/07/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

The Effect Of Red Meat And Resistant Starch On Bowel Health

Scientific title

Dietary protein-induced Deoxyribonucleic acid (DNA) damage in the colon: the effect of a high red meat diet compared to a high red meat diet supplemented with Resistant Starch (RS) in healthy volunteers aged 50-75 years

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Bowel disease

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Run in period (4 weeks consisting of normal diet with no added resistant starch) followed by 4 weeks of high red meat diet (300g per day) AND resistant starch 40g (20g twice a day, StarPlus (trademark) powder to be added to juice or custard), followed by a washout period (4 weeks consisting of normal diet) before moving onto 4 wks of a high red meat diet of 300g per day WITHOUT added Resistant starch.

Intervention code [1]

Prevention

Comparator / control treatment

Run in period (4 weeks consisting of normal diet with no added resistant starch) followed by 4 weeks of high red meat diet (300g per day) WITHOUT resistant starch 40g (20g twice a day, StarPlus (trademark) powder to be added to juice or custard), followed by a washout period (4 weeks consisting of normal diet) before moving onto 4 wks of a high red meat diet of 300g per day AND added Resistant starch.

Control group

Active

Outcomes

Primary outcome [1]

Effect of protein and Resistant Starch (RS) on formation of fermentation products

Faecal sample measures include: Faecal bulk, pH, carbohydrate fermentation products (short chain fatty acids), protein fermentation products (N-nitrosamines, phenols, cresols), microflora profile.

Rectal epithelium: Histological analysis of rectal epithelial: Deoxyribonucleic acid (DNA) strand breaks, O6-MeG DNA adducts, baseline apoptosis, cell proliferation, expression of methylguanine DNA methyltransferase (MGMT) and carcinogenesis-related factors (activity, micro Ribonucleic acid (mRNA), gene expression).

Timepoint [1]

Baseline - prior to intervention
wk 4 - end of first intervention
wk 8 - end of wash out
wk 12 - end of second intervention

Primary outcome [2]

Effect of protein and RS on epithelial consequences

Rectal epithelium: Histological analysis of rectal epithelial: DNA strand breaks, O6-MeG DNA adducts, baseline apoptosis, cell proliferation, expression of MGMT and carcinogenesis-related factors (activity, mRNA, gene expression).

Timepoint [2]

Baseline - prior to intervention
wk 4 - end of first intervention
wk 8 - end of wash out
wk 12 - end of second intervention

Secondary outcome [1]

Effect of protein and RS on bacterial profiles in faeces and rectal mucosa.

Faecal sample measures include: Faecal bulk, pH, carbohydrate fermentation products (short chain fatty acids), protein fermentation products (N-nitrosamines, phenols, cresols), microflora profile.

Rectal epithelium: Histological analysis of rectal epithelial: DNA strand breaks, O6-MeG DNA adducts, baseline apoptosis, cell proliferation, expression of MGMT and carcinogenesis-related factors (activity, mRNA, gene expression).

Timepoint [1]

Baseline - prior to intervention
wk 4 - end of first intervention
wk 8 - end of wash out
wk 12 - end of second intervention

Secondary outcome [2]

Effects of protein and Resistant Starch (RS) on colonocyte gene expression.

Blood samples: In the plasma/serum; we wish to test for changes in the levels of certain inflammatory markers like C-Reactive PRotein (CRP). Haemaglobin (Hb) & Mean Cell Volume (MCV) will be monitered. We will also test for micro Ribonucleic acid (micro-RNAs) in plasma as preliminary evidence suggests that some micro-RNAs act as biomarker for Colorectal Cancer (CRC).

Rectal epithelium: Histological analysis of rectal epithelial: Deoxyribonucleic acid (DNA) strand breaks, O6-MeG DNA adducts, baseline apoptosis, cell proliferation, expression of methylguanine DNA methyltransferase (MGMT) and carcinogenesis-related factors (activity, micro Ribonucleic acid (mRNA), gene expression).

Timepoint [2]

Baseline - prior to intervention
wk 4 - end of first intervention
wk 8 - end of wash out
wk 12 - end of second intervention

Eligibility

Key inclusion criteria

Participants will be of an age 50-75 years.
Healthy, with no active bowel disease.

Minimum age

50 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Evidence of any active mucosal bowel disease, eg colitis, or of malabsorption.
Intolerance to high-fibre foods.
Any perceived contraindication to consumption of the high protein diet.
Previous bowel surgery (excluding polypectomy).
Ingestion of regular laxatives or laxative derivatives (excluding regular fibre intake).
Ingestion of regular probiotic complimentary medicines.
Anitibiotic therapy in the previous four weeks.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

using a computer generated randomisation sequence

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2009

Actual

22/09/2009

Date of last participant enrolment

Anticipated

9/06/2010

Actual

9/06/2010

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Reserach Council (NHMRC)

Address [1]

National Health and Medical Research Council
Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Government body

Name

Department of Health South Australia (SA)

Address

Adelaide South Australia 5000

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

Southern Adelaide Health Service

Address [1]

Sir Mark Oliphant Building, Level 3A
Bedford Park South Australia 5042

Country [1]

Australia

Other collaborator category [1]

Commercial sector/Industry

Name [1]

Commonwealth Scientific Institute of Research Organisation (CSIRO)

Address [1]

Kintore Avenue
Adelaide SA 5000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Flinders Clinical Research & Ethics & Clinical Drug Trials Committees

Ethics committee address [1]

Flinders Medical Centre
1 Flinders Drive
Bedford Park 
SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/05/2009

Approval date [1]

09/07/2009

Ethics approval number [1]

155/09

Summary

Brief summary

The aim of this study is to ascertain the effects on  bowel health of resistant starch (StarPlus (trademark)) when given to participants who are ingesting a high red meat diet. Also to determine if the consumption of this high protein diet causes changes in certain markers for bowel cancer and if adding RS, ( StarPlus (trademark)) to the diet can improve these effects.

Trial website

Trial related presentations / publications

R. Le Leu, M. Conlon, J. Winter, K. Humphreys, M. Michael, Y. Hu, A. Bird, D. Topping, G. Young, Effect of high red meat intake and resistant starch in humans on risk factors for colorectal cancer. J. Gastroenterol. Hepatol. 27 (2012) 24-25.

the two below have been sent to journals for review:
 
1. To American Journal of Clinical Nutrition:
Title: Effects of red meat and butyrylated starch on rectal O6-methylguanine adducts, microbiota and biochemical biomarkers of colorectal cancer risk: a randomised cross-over clinical trial
Authors: Richard K Le Leu, Jean M Winter, Karen J Humphreys, Graeme P Young, Claus T Christophersen, Ying Hu, Silvia W Gratz, Rosalind B Miller, David L Topping, Anthony R Bird, and Michael A Conlon
 
2. To GUT journal:
Red meat and butyrylated high amylose maize starch alter microRNA expression in healthy rectal mucosa.   
Authors:  Karen J Humphreys, Michael A Conlon, Graeme P Young, David L Topping, Ying Hu, Jean M Winter, Anthony R Bird, Lynne Cobiac, Michael Z Michael and Richard K Le Leu.

Public notes

Contacts

Principal investigator

Name

Prof Prof Graeme Young

Address

Flinders Centre for Innovation in Cancer, Flinders University, Bedford Park SA 5042

Country

Australia

Phone

+61 8 8404 2841

Fax

graeme.young@flnders.edu.au

Contact person for public queries

Name

Jane Upton

Address

Department of Gastroenterology
Flinders Medical Centre
Bedford Park
SA 5042

Country

Australia

Phone

+61 8 82046071

Fax

+61 8 82046330

jane.upton@health.sa.gov.au

Contact person for scientific queries

Name

Dr Richard Le Leu

Address

Dept. of Gastroenterology
Flinders Medical Centre
Bedford Park SA 5042

Country

Australia

Phone

+61 8 82045170

Fax

+61 8 82043943

richard.leleu@flinders.edu.au

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Butyrylated starch intake can prevent red meat-induced O6-methyl-2-deoxyguanosine adducts in human rectal tissue: A randomised clinical trial.	2015	https://dx.doi.org/10.1017/S0007114515001750
Embase	Micromarkers 2.0: An update on the role of microRNAs in cancer diagnosis and prognosis.	2015	https://dx.doi.org/10.1586/14737159.2015.1081058
Dimensions AI	Microbial Metabolites in Colorectal Cancer: Basic and Clinical Implications	2021	https://doi.org/10.3390/metabo11030159

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