Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001191886
Ethics application status
Approved
Date submitted
9/11/2012
Date registered
13/11/2012
Date last updated
13/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The distribution of nutrient sensing abilities in the human gut
Scientific title
An observational study examining the expression of genes involved in taste and nutrient sensing in different regions of the gastrointestinal tract of healthy adults undergoing routine gastroscopy and/or colonoscopy procedures.
Secondary ID [1] 281515 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrient sensing 287784 0
Condition category
Condition code
Oral and Gastrointestinal 288135 288135 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Biopsy samples will be obtained from study participants on one occasion only during a routine gastroscopy and/or colonoscopy procedure.
Intervention code [1] 286034 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288334 0
Biopsy samples will be analysed using Real-Time quantitative PCR (qPCR) to determine the relative expression of mRNA encoding chemosensory proteins and associated signalling proteins in different regions of the gastrointestinal tract (stomach, small intestine and bowel).
Timepoint [1] 288334 0
Biospy samples (n=10) will be obtained from study participants on one occasion during a routine gastroscopy and/or colonoscopy procedure.
Secondary outcome [1] 299899 0
Tissue and cellular co-localisation of specific sensory proteins and associated signalling proteins will be determined using immunohistochemistry.
Timepoint [1] 299899 0
Biospy samples (n=10) will be obtained from study participants on one occasion during a routine gastroscopy and/or colonoscopy procedure.

Eligibility
Key inclusion criteria
Normal gross gastrointestinal tract anatomy
Generally healthy, as ascertained by self-report
Undergoing gastroscopy and/or colonoscopy examination
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Obese as defined by BMI >30kg/m2
Diagnosed diabetes mellitus (type 1 or 2)
Any medical conditions or medications known to affect gut function
Inflammatory or malignant diseases of the gut such as: Inflammatory bowel disease, ischemic bowel, celiac disease etc.
Taking the following medications: NSAIDS, glucocorticoids, immunomodulators, anticoagulants, weight loss medication.
Alcohol or drug dependency.
No extreme food restriction as seen in anorexia nervosa or binge eating plus purging (vomiting/using laxatives) and/or excessive physical activity as seen in bulimia or similar eating disorders that alter body composition in a short space of time
Unwilling/Unable to comply with study protocol
Previous GI tract resection
Participating in another clinical intervention trial

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 4673 0
New Zealand
State/province [1] 4673 0

Funding & Sponsors
Funding source category [1] 286296 0
Government body
Name [1] 286296 0
Ministry of Business, Innovation & Employment
Country [1] 286296 0
New Zealand
Primary sponsor type
Other
Name
The New Zealand Institute for Plant and Food Research
Address
120 Mt Albert Road
Sandringham
Auckland 1025
Country
New Zealand
Secondary sponsor category [1] 285089 0
Hospital
Name [1] 285089 0
Waitemata District Health Board
Address [1] 285089 0
Department of Gastroenterology
North Shore Hospital
124 Shakespeare Road
Takapuna
Auckland 0622
Country [1] 285089 0
New Zealand
Other collaborator category [1] 277166 0
University
Name [1] 277166 0
The University of Auckland
Address [1] 277166 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
Mt Eden
Auckland 1024
Country [1] 277166 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288371 0
Northern X Regional Ethics Committee
Ethics committee address [1] 288371 0
Ethics committee country [1] 288371 0
New Zealand
Date submitted for ethics approval [1] 288371 0
11/11/2011
Approval date [1] 288371 0
17/11/2011
Ethics approval number [1] 288371 0
NTX/11/08/077

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

Contacts
Principal investigator
Name 34934 0
Address 34934 0
Country 34934 0
Phone 34934 0
Fax 34934 0
Email 34934 0
Contact person for public queries
Name 18181 0
John Ingram
Address 18181 0
Plant and Food Research
Private Bag 92169
Auckland 1142
Country 18181 0
New Zealand
Phone 18181 0
+64 9 9257119
Fax 18181 0
+64 9 9257001
Email 18181 0
john.ingram@plantandfood.co.nz
Contact person for scientific queries
Name 9109 0
John Ingram
Address 9109 0
Plant and Food Research
Private Bag 92169
Auckland 1142
Country 9109 0
New Zealand
Phone 9109 0
+64 9 9257119
Fax 9109 0
+64 9 9257001
Email 9109 0
john.ingram@plantandfood.co.nz

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
No additional documents have been identified.