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Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities

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University of Michigan

Status

Completed

Conditions

Overweight/Obese Women

Treatments

Other: High Fat Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT01451970
N009310

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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%

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 2 patient groups

High Monounsaturated Fat Diet
Other group
Description:
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.
Treatment:
Other: High Fat Diet
High Saturated Fat Diet
Other group
Description:
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.
Treatment:
Other: High Fat Diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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