Healthy Oils for Women (HOW Study)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: High Linoleic Safflower Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Linoleic Acid<br> | Dietary Supplement: High Linoleic Safflower Oil<br>* 2 tsp per day ( 10g of oil)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in trunk adipose mass |  | Baseline and Week 16 (end of the study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Alpha and Gamma Tocopherol Levels |  | Baseline through Week 16 (end of the study) | 
| Changes in mood | Mood questionnaires will be completed at each study visit | Baseline through Week 16 (end of the study) | 
| Changes in Lipid Profile |  | Baseline through Week 16 (end of the Study) | 
| Oil Supplementation Compliance | Plasma and red blood cell fatty acid composition will be analyzed. Returned oil containers will be weighed to estimate oil consumption. | Baseline through Week 16 (end of the study) | 
| Changes in glycemic control | Serum glucose and insulin levels will be analyzed | Baseline through Week 16 (end of the study) | 
| Changes in lean mass |  | Baseline and Week 16 (end of the study) | 
| Changes in visceral adipose tissue |  | Baseline and Week 16 (end of study) | 
| Changes in adipocytokine levels | Adiponectin, leptin, and IL-6 will be analyzed | Baseline through Week 16 (end of the study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safflower Oil, Linoleic Acid, Dyslipidemia, Hypertension