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
  Purpose

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 Intervention
Overweight/Obese Women
Other: High Fat Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 2-3 hours ] [ Designated as safety issue: No ]
    A hyperinsulinemic-euglycemic clamp will be used to assess insulin sensitivity.


Secondary Outcome Measures:
  • Resting Metabolic Rate [ Time Frame: 20-30 min ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2007
Estimated Study Completion Date: January 2014
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
High Fat Diet Treatment 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451970

Locations
United States, Michigan
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
  More Information

No publications provided

Responsible Party: JEFFREY F HOROWITZ, Associate Professor, Movement Science, School of Kinesiology, University of Michigan
ClinicalTrials.gov Identifier: NCT01451970     History of Changes
Other Study ID Numbers: N009310
Study First Received: October 11, 2011
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
high fat diet treatment
insulin sensitivity

Additional relevant MeSH terms:
Overweight
Insulin Resistance
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014