Healthy Oils for Women (HOW Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-08-31

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.

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Linoleic Acid

Group Type EXPERIMENTAL

High Linoleic Safflower Oil

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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High Linoleic Safflower Oil

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

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No