Cholesterol and Fatty Acid Synthesis in Islet and Liver Transplant Patients and Effect of Dietary Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Immunosuppression Hyperlipidemias Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Islet transplant

People with Type 1 diabetes undergoing islet transplantation

Group Type EXPERIMENTAL

Dietary intervention - supplements

Intervention Type DIETARY_SUPPLEMENT

Supplement bar \& spread formulated with key nutrients (fish oil, phytosterols, almonds, soy protein) shown to help in reducing blood lipid levels

Liver transplant

People with liver failure undergoing liver transplantation

Group Type EXPERIMENTAL

Dietary intervention - supplements

Intervention Type DIETARY_SUPPLEMENT

Supplement bar \& spread formulated with key nutrients (fish oil, phytosterols, almonds, soy protein) shown to help in reducing blood lipid levels

Control

Healthy normal people which serve as control group

Group Type EXPERIMENTAL

Dietary intervention - supplements

Intervention Type DIETARY_SUPPLEMENT

Supplement bar \& spread formulated with key nutrients (fish oil, phytosterols, almonds, soy protein) shown to help in reducing blood lipid levels

Interventions

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Dietary intervention - supplements

Supplement bar \& spread formulated with key nutrients (fish oil, phytosterols, almonds, soy protein) shown to help in reducing blood lipid levels

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes