Healthy Oils for Women (HOW Study)

Metabolic Syndrome Clinical Trial

— HOW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063165
• Other study ID #: 2012H0259
• Secondary ID: 2011-039
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: August 2015

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• High Linoleic Safflower Oil
2 tsp per day (~10g of oil)

Locations

Country	Name	City	State
United States	The Ohio State University Exercise Physiology Lab	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Corr-Jensen, LLC provided some of the study oil from Arista Industries, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in trunk adipose mass		Baseline and Week 16 (end of the study)
Secondary	Changes in Alpha and Gamma Tocopherol Levels		Baseline through Week 16 (end of the study)
Secondary	Changes in mood	Mood questionnaires will be completed at each study visit	Baseline through Week 16 (end of the study)
Secondary	Changes in Lipid Profile		Baseline through Week 16 (end of the Study)
Secondary	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)
Secondary	Changes in glycemic control	Serum glucose and insulin levels will be analyzed	Baseline through Week 16 (end of the study)
Secondary	Changes in lean mass		Baseline and Week 16 (end of the study)
Secondary	Changes in visceral adipose tissue		Baseline and Week 16 (end of study)
Secondary	Changes in adipocytokine levels	Adiponectin, leptin, and IL-6 will be analyzed	Baseline through Week 16 (end of the study)