None listed
Conditions
Brief summary
Intestinal barrier perturbation is a central mechanism to a multitude of diseases but its function has proven elusive to measure. Clearer experimental models of barrier dysfunction induction and reliable non-invasive markers are required. Currently we do not have a good way to intestinal permeability or 'leaky gut' The aim of this study is to help develop blood tests which will help with this measurement. We hypothesise that both the high fat, high carbohydrate meal as well as the injection of corticotropin releasing hormone will cause a significant disruption to the intestinal barrier function that will be measurable with the blood tests that we are testing.
Interventions
The interventions for the participants will include:
- Intravenous injection of 100 micrograms of corticotropin releasing hormone
- High fat, high carbohydrate meal which contains 56-60 g total fat, 82 g carbohydrate and 28-30 g protein.
Each of the above 2 interventions will be separated by at least a 2 week time period
The study doctor will administer all of the interventions
Each intervention will only be given once over the course of the 3 visits. The shortest interval will be 6 weeks and
The interventions for the participants will include: - Intravenous injection of 100 micrograms of corticotropin releasing hormone - High fat, high carbohydrate meal which contains 56-60 g total fat, 82 g carbohydrate and 28-30 g protein. Each of the above 2 interventions will be separated by at least a 2 week time period The study doctor will administer all of the interventions Each intervention will only be given once over the course of the 3 visits. The shortest interval will be 6 weeks and there is no upper limit on time between the interventions. All interventions will occur at the Alfred Hospital, in the gastroenterology department study room. All interventions will be administered under clinical monitoring. The washout period is 2 weeks between interventions
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
• Healthy males and females between the ages of 18 – 65 • Participants who are able to give informed consent • Volunteers should be able to attend Monash University, Alfred Campus on 7 occasions
Exclusion criteria
• Inclusion criteria not met • Past medical history of diabetes (type 1 or 2) • Past medical history of inflammatory bowel disease, coeliac disease, a diagnosis of irritable bowel syndrome or significant gastrointestinal symptoms not otherwise medically diagnosed • Patients actively taking non-steroidal anti-inflammatory medications (NSAIDs) or corticosteroids • Probiotic or antibiotic intake over the past 2 months • Pregnant or breast feeding participants • Allergy or intolerance to the components of the proposed meals
Outcome results
None listed