Plasma Lipid Response to Glucose Drink

Study Overview
=================
Brief Summary
-----------------
During dietary fat absorption, the gut packages the majority of the fats into lipid particles that are secreted into blood circulation. The gut is also capable of storing a considerable amount of fats that can be released at a later time upon receiving certain stimulus signals. One of the signals is glucose ingestion. This protocol examines blood lipid responses to a glucose drink. Participants drink a fatty formula and 5 hours later drink either a glucose solution or water (as control), in one of two randomized study visits. Blood lipid levels are monitored throughout the study period.

Detailed Description
-----------------
Participants are recruited after obtaining informed consent. They first have a high fat liquid formula. 5 hours later, they drink 50 grams of glucose in 50 ml of water in one visit and 50 ml of water in another. The 2 visits are randomized. Blood samples are taken before and after they drink the high fat liquid formula, and continued until 3 hours after they drink glucose or water. Lipid levels in the blood samples are measured in the lab.

Official Title
-----------------
Investigating the Molecular Mechanisms Underpinning Glucose Stimulated Release of Stored Enteral Lipid in Humans

Conditions
-----------------
Hyperlipidemias

Intervention / Treatment
-----------------
* Dietary Supplement: Glucose
* Dietary Supplement: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by Dr. Bookman. Body mass index 20 to 27 kg/m2 Exclusion Criteria: Patients with active inflammatory bowel disease Patients with Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption Patients with active bowel malignancy Patients with diabetes mellitus or known/ suspected motility disorders of the gut Patients with decompensated liver disease Patients on ezetemibe or bile acid sequestrants Unstable cardiac or respiratory disease Any changes to medication in the preceding month.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucose<br>50 grams of glucose in 50 ml water | Dietary Supplement: Glucose<br>* Glucose drink<br>|
| Placebo Comparator: Water<br>50 ml water | Dietary Supplement: Water<br>* Control<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipid responses to glucose drink | Blood lipid levels are measured after drinking a glucose solution | 8 hours |