Healthy Oils for Women (HOW Study)



Status:Completed
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:50 - 69
Updated:4/21/2016
Start Date:February 2014
End Date:August 2015

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Healthy Oils for Women: Reducing Visceral Adipose Tissue in Women With Metabolic Syndrome (HOW Study)

The purpose of this study is to understand the role of a dietary oil to alter chronic
disease risk factors in women who are at risk for heart disease and/or diabetes. The
investigator's previous study showed that safflower oil reduced trunk fat mass in women with
diabetes. The investigators believe safflower oil can also attenuate criteria of metabolic
syndrome through reduction in trunk fat mass.

The long-term goal is to develop effective and novel dietary and lifestyle strategies to
reduce the progression of metabolic syndrome to chronic diseases such as coronary heart
disease. The rationale for conducting this research study is that there are few effective
strategies that target changes in body composition and metabolism as a means to attenuate
metabolic syndrome. The investigators plan to test the central hypothesis and accomplish the
overall objective of this research by pursuing the following three specific aims.

Specific Aim 1: Quantify the extent that linoleic acid reduces trunk adipose mass in women
with metabolic syndrome.

Specific Aim 2: Measure changes in visceral adipose tissue

Specific Aim 3: Determine the time-dependent effect of linoleic acid to increase adiponectin
levels.

Inclusion Criteria:

- Female

- Post-menopausal (cessation of menses ≥12 months)

- Age ≥ 50 and ≤ 69 years

- At Least one of the following metabolic syndrome criteria

- Elevated triglycerides (>150mg/dl)

- Reduced HDL-C (<50mg/dl)

- Elevated blood pressure (>130mm Hg systolic or > 85 mm Hg diastolic)

- Elevated blood glucose (>100mg/dl and <126mg/dl)

- Obese (BMI ≥ 30 kg/m² and ≤ 55 kg/m²)

- Stable medical therapy for past 3 months

- Stable body weight (within ± 2 kg) for past 3 months

- Waist circumference >88cm (35 inches)

Exclusion Criteria:

- Substance abuse

- Current/previous diagnosis of type 2 diabetes or fasting blood glucose ≥126 mg/dL

- Current use of medications or supplements known to affect body composition

- Current or previous use of oral hypoglycemic agents or exogenous insulin.

- Impaired cognitive function

- Current or previous diagnosis of renal, heart, or circulatory disease

- Gastrointestinal diseases or disorders
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