Study Results
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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COMPLETED
NA
24 participants
INTERVENTIONAL
2012-03-31
2014-02-28
Brief Summary
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The investigators also plan to evaluate endothelial dysfunction and blood pressure; both of which frequently accompany insulin resistance.
Detailed Description
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This study is intended to determine if the main types of fat (saturated, monounsaturated and polyunsaturated) ingested over a short time can cause insulin resistance in lean, healthy people. It has been demonstrated that 6 hours of intravenous fat infused into lean, healthy subjects can result in insulin resistance, as well as blood pressure elevation and endothelial dysfunction. Whether this is so with oral fat is not known. The question is important because there is debate about whether the type of fat is as important as the quantity of fat in a person's daily diet. Settling this debate will enhance the ability of health care personnel to determine the optimal dietary recommendations.
This study will make use of a high fat diet consisting of vegetable oils high in the 3 main fatty acids in plasma (palmitate, oleate and linoleate). Because large fat loads can cause intestinal discomfort, a feeding tube will be used to bypass the stomach. The 3 oils will be assigned randomly following a base line study with saline 2 weeks prior to the intervention. Our primary endpoint is insulin resistance, which will be measured by a euglycemic, hyperinsulinemic clamp. Secondary measures will include changes in blood pressure and in vascular reactivity as measured by ultrasound after brief occlusion of a forearm vessel. The changes will be compared to baseline and to the other 2 groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Saturated fat
Palm oil (rich in the saturated fat palmitate)
Dietary fat
On the study day, each participant will receive 100 grams of a randomly assigned fat via a nasoduodenal tube. The oil will be infused at a rate of \~1 tablespoon per hour so that the total infusion time will be 6 hours.
Monounsaturated fat
Olive oil (rich in the monounsaturated fat oleate)
Dietary fat
On the study day, each participant will receive 100 grams of a randomly assigned fat via a nasoduodenal tube. The oil will be infused at a rate of \~1 tablespoon per hour so that the total infusion time will be 6 hours.
Polyunsaturated fat
Safflower oil (rich in the polyunsaturated fat linoleate)
Dietary fat
On the study day, each participant will receive 100 grams of a randomly assigned fat via a nasoduodenal tube. The oil will be infused at a rate of \~1 tablespoon per hour so that the total infusion time will be 6 hours.
Interventions
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Dietary fat
On the study day, each participant will receive 100 grams of a randomly assigned fat via a nasoduodenal tube. The oil will be infused at a rate of \~1 tablespoon per hour so that the total infusion time will be 6 hours.
Eligibility Criteria
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Inclusion Criteria
* No chronic medications (birth control pills allowed)
* Weight stable
* Normal fasting labs performed at screening
* Body mass index ≤ 25 kg/M\^2 .
Exclusion Criteria
* Thyroid disease
* History of diabetes or heart disease
* History of type 2 diabetes in parent or sibling
18 Years
40 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Robert.H.Nelson
Assistant Professor of Family Medicine and Medicine
Principal Investigators
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Robert Nelson, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Other Identifiers
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11-000179
Identifier Type: -
Identifier Source: org_study_id