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Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities

Primary Purpose

Overweight/Obese Women

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Fat Diet
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight/Obese Women focused on measuring high fat diet treatment, insulin sensitivity

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Premenopausal females with BMI range of 25-32 kg/m2

Exclusion Criteria:

  • Evidence of metabolic or cardiovascular disease, Fasting plasma glucose concentration > 125mg/dl, Abnormal EKG, Hyperlipidemia (plasma triglyceride concentration > 150mg/dl), Pregnancy, Hematocrit <34%

Sites / Locations

  • Michigan Clincal Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

High Monounsaturated Fat Diet

High Saturated Fat Diet

Arm Description

Subjects will adhere to their specific diet for four weeks. The diet will be a weight-maintaining diet, and the target nutrient composition for diets will be 55% carbohydrate, 30% fat, 15% protein. For the monounsaturated fat treatment (M diet) approximately 10% of all lipids ingested will be saturated.

Subjects will adhere to their specific diet for four weeks. The diet will be a weight-maintaining diet, and the target nutrient composition for diets will be 55% carbohydrate, 30% fat, 15% protein. For the saturated fat treatment (S diet) approximately 40% of all lipids ingested will be saturated.

Outcomes

Primary Outcome Measures

Insulin Sensitivity
A hyperinsulinemic-euglycemic clamp will be used to assess insulin sensitivity.

Secondary Outcome Measures

Resting Metabolic Rate

Full Information

First Posted
October 11, 2011
Last Updated
March 18, 2022
Sponsor
University of Michigan
Collaborators
Robert C. Atkins Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01451970
Brief Title
Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities
Official Title
Assessing the Effects of Two Diets Enriched in Either Saturated or Unsaturated Fatty Acids to Determine the Cellular and Molecular Mechanisms in Insulin Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 12, 2010 (Actual)
Study Completion Date
December 12, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Robert C. Atkins Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Individuals have a significant capacity to adapt to different environments by changing their core metabolic pathways. This adaptation is especially important in regards to diet. Epidemiological research over the last several decades have shown that diets high in saturated fats have a greater ability to cause insulin resistance and the 'metabolic syndrome' while diets low in saturated fats (or a so called 'Mediterranean Diet), reduces the risk for cardiovascular disease. In humans, experimental diets high in unsaturated fats, as compared to high carbohydrate or high saturated fat diets, result in increased insulin sensitivity and improved lipid profiles. In this application, the investigators propose to systematically assess the effects of two diets enriched in either saturated or unsaturated fatty acids and determine the cellular and molecular mechanisms of the apparent increase in insulin sensitivity. The investigators hypothesize that individuals will 'adapt' to the different diets and the investigators will be able to generate predictive alterations in gene expression and metabolites that underlie the alterations in metabolism. In parallel, the investigators will test the ability of these different diets to affect the release of gastrointestinal hormones that may be critical to modulation of appetite.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight/Obese Women
Keywords
high fat diet treatment, insulin sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Monounsaturated Fat Diet
Arm Type
Other
Arm Description
Subjects will adhere to their specific diet for four weeks. The diet will be a weight-maintaining diet, and the target nutrient composition for diets will be 55% carbohydrate, 30% fat, 15% protein. For the monounsaturated fat treatment (M diet) approximately 10% of all lipids ingested will be saturated.
Arm Title
High Saturated Fat Diet
Arm Type
Other
Arm Description
Subjects will adhere to their specific diet for four weeks. The diet will be a weight-maintaining diet, and the target nutrient composition for diets will be 55% carbohydrate, 30% fat, 15% protein. For the saturated fat treatment (S diet) approximately 40% of all lipids ingested will be saturated.
Intervention Type
Other
Intervention Name(s)
High Fat Diet
Intervention Description
Subjects will adhere to their specific diet for four weeks. For both diet treatments, the diet will be a weight-maintaining diet, and the target nutrient composition for diets will be 55% carbohydrate, 30% fat, 15% protein. For the monounsaturated fat treatment (M diet) approximately 10% of all lipids ingested will be saturated. For the saturated fat treatment (S diet) approximately 40% of all lipids ingested will be saturated.
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
A hyperinsulinemic-euglycemic clamp will be used to assess insulin sensitivity.
Time Frame
2-3 hours
Secondary Outcome Measure Information:
Title
Resting Metabolic Rate
Time Frame
20-30 min

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Premenopausal females with BMI range of 25-32 kg/m2 Exclusion Criteria: Evidence of metabolic or cardiovascular disease, Fasting plasma glucose concentration > 125mg/dl, Abnormal EKG, Hyperlipidemia (plasma triglyceride concentration > 150mg/dl), Pregnancy, Hematocrit <34%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey F Horowitz, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Clincal Research Unit
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities

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