Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities

NCT01451970 | Completed

• 1 other identifier: N009310
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

high fat diet treatment; insulin sensitivity

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

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

  2-3 hours

Secondary Outcomes (1)

• Resting Metabolic Rate

  20-30 min

Study Arms (2)

High Monounsaturated Fat Diet

OTHER

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

High Saturated Fat Diet

OTHER

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

Interventions

High Fat Diet 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 Monounsaturated Fat Diet; High Saturated Fat Diet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• Robert C. Atkins Foundation: collaborator

Study Sites (1)

Michigan Clincal Research Unit

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Overweight; Insulin Resistance

Interventions

Diet, High-Fat

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jeffrey F Horowitz, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Movement Science, School of Kinesiology

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 14, 2011
• Study Start: August 1, 2007
• Primary Completion: December 12, 2010
• Study Completion: December 12, 2010
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

US (1)