Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities

NCT ID: NCT01451970

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-12-12

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.

Conditions

Overweight/Obese Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

High Fat Diet

Intervention Type: OTHER

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.

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.

Group Type: OTHER

High Fat Diet

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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%

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Robert C. Atkins Foundation

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey F Horowitz

Associate Professor, Movement Science, School of Kinesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey F Horowitz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Michigan Clincal Research Unit

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

N009310

Identifier Type: -

Identifier Source: org_study_id