Does Class of Dietary Fat Affect Insulin Resistance?

NCT01541592 | Completed

• 1 other identifier: 11-000179
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

It has been shown that intravenous fatty acids given to normal volunteers in the form of heparin and lipid emulsions will cause insulin resistance in a matter of a few hours. It is not known if this same phenomenon can be demonstrated with oral fat. The investigators are specifically interested in whether or not there are differences in the induction of insulin resistance between the 3 main classes of fatty acids (saturated, monounsaturated and polyunsaturated). The investigators also plan to evaluate endothelial dysfunction and blood pressure; both of which frequently accompany insulin resistance.

Conditions

Insulin Resistance

Keywords

Insulin resistance; Endothelial dysfunction; saturated fat; monounsaturated fat; polyunsaturated fat

Outcome Measures

Primary Outcomes (1)

• Change in Insulin Sensitivity from Baseline at Two Weeks

  Insulin sensitivity will be measured twice (once at baseline following a nasoduodenal infusion of saline for 6 hours; two weeks later following a nasoduodenal infusion of a vegetable oil high in one of 3 fatty acids for 6 hours) using a euglycemic, hyperinsulinemic clamp as described by R. DeFronzo. The actual measurement is expressed as a glucose infusion rate.

  Average of 2 weeks.

Secondary Outcomes (2)

• Change in Endothelial Function from Baseline at Two Weeks

  Average of two weeks

• Change in Systolic Blood Pressure at Two Weeks

  Average of two weeks

Study Arms (3)

Saturated fat

ACTIVE COMPARATOR

Palm oil (rich in the saturated fat palmitate)

Other: Dietary fat

Monounsaturated fat

ACTIVE COMPARATOR

Olive oil (rich in the monounsaturated fat oleate)

Other: Dietary fat

Polyunsaturated fat

ACTIVE COMPARATOR

Safflower oil (rich in the polyunsaturated fat linoleate)

Other: Dietary fat

Interventions

Dietary fat OTHER

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; Polyunsaturated fat; Saturated fat

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Lean,healthy adults 18 - 40
• No chronic medications (birth control pills allowed)
• Weight stable
• Normal fasting labs performed at screening
• Body mass index ≤ 25 kg/M\^2 .

You may not qualify if:

• Insulin dependent diabetes
• Thyroid disease
• History of diabetes or heart disease
• History of type 2 diabetes in parent or sibling

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Dietary Fats

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fats; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Robert Nelson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Family Medicine and Medicine

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 1, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 26, 2014

Record last verified: 2014-11

Locations

US (1)