Healthy Oils for Women: Reducing Visceral Adipose Tissue in Women with Metabolic Syndrome (HOW Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ohio State University
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Changes in trunk adipose mass
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 69 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Changes in trunk adipose mass
Time Frame: Baseline and Week 16 (end of the study)
Secondary Outcomes
- Changes in lean mass(Baseline and Week 16 (end of the study))
- Changes in mood(Baseline through Week 16 (end of the study))
- Changes in glycemic control(Baseline through Week 16 (end of the study))
- Changes in visceral adipose tissue(Baseline and Week 16 (end of study))
- Changes in Lipid Profile(Baseline through Week 16 (end of the Study))
- Oil Supplementation Compliance(Baseline through Week 16 (end of the study))
- Changes in Alpha and Gamma Tocopherol Levels(Baseline through Week 16 (end of the study))
- Changes in adipocytokine levels(Baseline through Week 16 (end of the study))
Investigators
Martha Belury
Carol S. Kennedy Professor of Nutrition
Ohio State University