Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Robert C. Atkins Foundation
Information provided by (Responsible Party):
JEFFREY F HOROWITZ, University of Michigan
ClinicalTrials.gov Identifier:
NCT01451970
First received: October 11, 2011
Last updated: March 13, 2013
Last verified: March 2013

October 11, 2011
March 13, 2013
August 2007
February 2012   (final data collection date for primary outcome measure)
Insulin Sensitivity [ Time Frame: 2-3 hours ] [ Designated as safety issue: No ]
A hyperinsulinemic-euglycemic clamp will be used to assess insulin sensitivity.
Same as current
Complete list of historical versions of study NCT01451970 on ClinicalTrials.gov Archive Site
Resting Metabolic Rate [ Time Frame: 20-30 min ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities
Assessing the Effects of Two Diets Enriched in Either Saturated or Unsaturated Fatty Acids to Determine the Cellular and Molecular Mechanisms in Insulin Sensitivity

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Overweight/Obese Women
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.
High Fat Diet Treatment
Intervention: Other: High Fat Diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
January 2014
February 2012   (final data collection date for primary outcome measure)

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%
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01451970
N009310
No
JEFFREY F HOROWITZ, University of Michigan
University of Michigan
Robert C. Atkins Foundation
Principal Investigator: Jeffrey F Horowitz, Ph.D. University of Michigan
University of Michigan
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP