Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT01451970

Collaborator

Robert C. Atkins Foundation (Other)

Enrollment

Location

Arms

40.4

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight/Obese Women	Other: High Fat Diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Dec 12, 2010

Actual Study Completion Date :

Dec 12, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: High Monounsaturated Fat Diet 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.	Other: High Fat Diet 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.
Other: High Saturated Fat Diet 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.	Other: High Fat Diet 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.

Arm

Intervention/Treatment

Other: High Monounsaturated Fat Diet

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.

Other: High Fat Diet

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.

Other: High Saturated Fat Diet

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.

Other: High Fat Diet

Outcome Measures

Primary Outcome Measures

Insulin Sensitivity [2-3 hours]
A hyperinsulinemic-euglycemic clamp will be used to assess insulin sensitivity.

Secondary Outcome Measures

Resting Metabolic Rate [20-30 min]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michigan Clincal Research Unit	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan
Robert C. Atkins Foundation

Investigators

Principal Investigator: Jeffrey F Horowitz, Ph.D., University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeffrey F Horowitz, Associate Professor, Movement Science, School of Kinesiology, University of Michigan

ClinicalTrials.gov Identifier:

NCT01451970

Other Study ID Numbers:

N009310

First Posted:

Oct 14, 2011

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Keywords provided by Jeffrey F Horowitz, Associate Professor, Movement Science, School of Kinesiology, University of Michigan

high fat diet treatment

insulin sensitivity

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Mar 21, 2022