Cholesterol and Fatty Acid Synthesis in Islet and Liver Transplant Patients and Effect of Dietary Intervention
Study Details
Study Description
Brief Summary
The purpose is to investigate possible mechanisms of increased blood lipid levels following transplantation, and also to see if a comprehensive dietary intervention is effective in reducing blood lipid levels in post-transplant patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
Post-transplantation patients frequently have an increase in blood lipid levels presumed to be due to immunosuppressive agents, however it is currently unknown the mechanisms by which this occurs. Dietary interventions have frequently been unsuccessful in these patients, which may be due to single-nutrient interventions and lack of support and guidance. This research will use stable isotope methods to estimate cholesterol and fatty acid synthesis to determine if these pathways are affected by immunosuppression in patients before and after islet and liver transplant. In addition, it will be determined if a multi-nutrient dietary intervention will be implemented post-transplant can reduce blood lipid levels in to prevent further polypharmacy these patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Islet transplant People with Type 1 diabetes undergoing islet transplantation |
Dietary Supplement: Dietary intervention - supplements
Supplement bar & spread formulated with key nutrients (fish oil, phytosterols, almonds, soy protein) shown to help in reducing blood lipid levels
|
| Experimental: Liver transplant People with liver failure undergoing liver transplantation |
Dietary Supplement: Dietary intervention - supplements
Supplement bar & spread formulated with key nutrients (fish oil, phytosterols, almonds, soy protein) shown to help in reducing blood lipid levels
|
| Experimental: Control Healthy normal people which serve as control group |
Dietary Supplement: Dietary intervention - supplements
Supplement bar & spread formulated with key nutrients (fish oil, phytosterols, almonds, soy protein) shown to help in reducing blood lipid levels
|
Outcome Measures
Primary Outcome Measures
- Cholesterol and fatty acid synthesis [Pre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)]
Secondary Outcome Measures
- Blood lipid levels [Pre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
on islet or liver transplant list
-
post-transplant >3 months
-
physically able to participate in study and intervention
Exclusion Criteria:
-
< 18 years of age
-
family history of premature cardiovascular disease or familial hyperlipidemia (control subjects)
-
cholestatic diseases (liver transplant patients)
-
type 2 diabetes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alberta | Edmonton | Alberta | Canada | T6G 2P5 |
Sponsors and Collaborators
- University of Alberta
- Canadian Institutes of Health Research (CIHR)
Investigators
- Principal Investigator: Michael T Clandinin, PhD, University of Alberta
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Islet-Liver-MTC