Healthy Oils for Women (HOW Study)

N/ACompletedNCT02063165

Ohio State University18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metabolic Syndrome

Interventions

High Linoleic Safflower OilDIETARY_SUPPLEMENT

2 tsp per day (\~10g of oil)

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University Exercise Physiology Lab

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Changes in trunk adipose mass

Time frame: Baseline and Week 16 (end of the study)

Secondary Outcomes

Changes in Alpha and Gamma Tocopherol Levels

Time frame: Baseline through Week 16 (end of the study)

Changes in mood

Mood questionnaires will be completed at each study visit

Time frame: Baseline through Week 16 (end of the study)

Changes in Lipid Profile

Time frame: 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.

Time frame: Baseline through Week 16 (end of the study)

Changes in glycemic control

Serum glucose and insulin levels will be analyzed

Time frame: Baseline through Week 16 (end of the study)

Changes in lean mass

Time frame: Baseline and Week 16 (end of the study)

Changes in visceral adipose tissue

Time frame: Baseline and Week 16 (end of study)

Changes in adipocytokine levels

Adiponectin, leptin, and IL-6 will be analyzed

Time frame: Baseline through Week 16 (end of the study)

Data from ClinicalTrials.gov

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