Healthy Oils for Women (HOW Study)

The Ohio State University

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Dietary Supplement: High Linoleic Safflower Oil

Study type

Interventional

Funder types

Other

Identifiers

NCT02063165

2012H0259

2011-039 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

18 patients

Sex

Female

Ages

50 to 69 years old

Volunteers

No Healthy Volunteers

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