Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities

Overweight/Obese Women Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451970
• Other study ID #: N009310
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: December 12, 2010

Study information

• Verified date: March 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 12, 2010
• Est. primary completion date: December 12, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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%

Related Conditions & MeSH terms

• Overweight
• Overweight/Obese Women

Intervention

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.

Locations

Country	Name	City	State
United States	Michigan Clincal Research Unit	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Robert C. Atkins Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity	A hyperinsulinemic-euglycemic clamp will be used to assess insulin sensitivity.	2-3 hours
Secondary	Resting Metabolic Rate		20-30 min