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Completed

NCT Number: NCT02063165

Healthy Oils for Women (HOW Study)

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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Key information

Age range

50 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Exercise Physiology Lab

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Linoleic Safflower Oil

Dietary Supplement

2 tsp per day (~10g of oil)

Primary outcomes

  1. Changes in trunk adipose mass

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

Secondary outcomes

  1. Changes in Alpha and Gamma Tocopherol Levels

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

  2. Changes in mood

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

    Mood questionnaires will be completed at each study visit

  3. Changes in Lipid Profile

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

  4. Oil Supplementation Compliance

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

    Plasma and red blood cell fatty acid composition will be analyzed. Returned oil containers will be weighed to estimate oil consumption.

  5. Changes in glycemic control

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

    Serum glucose and insulin levels will be analyzed

  6. Changes in lean mass

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

  7. Changes in visceral adipose tissue

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

  8. Changes in adipocytokine levels

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

    Adiponectin, leptin, and IL-6 will be analyzed

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Corr-Jensen, LLC provided some of the study oil from Arista Industries, Inc

Registry information

Official study title

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

Acronym: HOW

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 14, 2014
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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