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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] 871 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel disease 4793 0
Condition category
Condition code
Oral and Gastrointestinal 237137 237137 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
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] 4566 0
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] 237956 0
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] 237956 0
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] 237957 0
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] 237957 0
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] 242054 0
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] 242054 0
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] 242055 0
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] 242055 0
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
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] 4964 0
Government body
Name [1] 4964 0
National Health and Medical Reserach Council (NHMRC)
Address [1] 4964 0
National Health and Medical Research Council
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 4964 0
Australia
Primary sponsor type
Government body
Name
Department of Health South Australia (SA)
Address
Adelaide South Australia 5000
Country
Australia
Secondary sponsor category [1] 4489 0
Government body
Name [1] 4489 0
Southern Adelaide Health Service
Address [1] 4489 0
Sir Mark Oliphant Building, Level 3A
Bedford Park South Australia 5042
Country [1] 4489 0
Australia
Other collaborator category [1] 670 0
Commercial sector/Industry
Name [1] 670 0
Commonwealth Scientific Institute of Research Organisation (CSIRO)
Address [1] 670 0
Kintore Avenue
Adelaide SA 5000
Country [1] 670 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7068 0
Flinders Clinical Research & Ethics & Clinical Drug Trials Committees
Ethics committee address [1] 7068 0
Flinders Medical Centre
1 Flinders Drive
Bedford Park
SA 5042
Ethics committee country [1] 7068 0
Australia
Date submitted for ethics approval [1] 7068 0
18/05/2009
Approval date [1] 7068 0
09/07/2009
Ethics approval number [1] 7068 0
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 29610 0
Prof Prof Graeme Young
Address 29610 0
Flinders Centre for Innovation in Cancer, Flinders University, Bedford Park SA 5042
Country 29610 0
Australia
Phone 29610 0
+61 8 8404 2841
Fax 29610 0
Email 29610 0
graeme.young@flnders.edu.au
Contact person for public queries
Name 12857 0
Ms Jane Upton
Address 12857 0
Department of Gastroenterology
Flinders Medical Centre
Bedford Park
SA 5042
Country 12857 0
Australia
Phone 12857 0
+61 8 82046071
Fax 12857 0
+61 8 82046330
Email 12857 0
jane.upton@health.sa.gov.au
Contact person for scientific queries
Name 3785 0
Dr Dr Richard Le Leu
Address 3785 0
Dept. of Gastroenterology
Flinders Medical Centre
Bedford Park SA 5042
Country 3785 0
Australia
Phone 3785 0
+61 8 82045170
Fax 3785 0
+61 8 82043943
Email 3785 0
richard.leleu@flinders.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary