Healthy Oils for Women (HOW Study) (HOW)

Healthy Oils for Women: Reducing Visceral Adipose Tissue in Women With Metabolic Syndrome (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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: High Linoleic Safflower Oil

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Exercise Physiology Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Linoleic Acid	Dietary supplement: High Linoleic Safflower Oil; 2 tsp per day (~10g of oil)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in trunk adipose mass	Baseline and Week 16 (end of the study)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Corr-Jensen, LLC provided some of the study oil from Arista Industries, Inc
• Investigators: Principal Investigator: Martha A Belury, PhD, RD, The Ohio State University, Department of Human Sciences, Human Nutrition Program

Publications and helpful links

General Publications

• Cole RM, Puchala S, Ke JY, Abdel-Rasoul M, Harlow K, O'Donnell B, Bradley D, Andridge R, Borkowski K, Newman JW, Belury MA. Linoleic Acid-Rich Oil Supplementation Increases Total and High-Molecular-Weight Adiponectin and Alters Plasma Oxylipins in Postmenopausal Women with Metabolic Syndrome. Curr Dev Nutr. 2020 Aug 21;4(9):nzaa136. doi: 10.1093/cdn/nzaa136. eCollection 2020 Sep.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (Estimated): February 14, 2014

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Dyslipidemia; Hypertension; Safflower Oil; Linoleic Acid
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 2012H0259; 2011-039 (Other Grant/Funding Number: Ohio Agricultural Research and Development Center)