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Healthy Oils for Women (HOW Study) (HOW)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Linoleic Safflower Oil
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Safflower Oil, Linoleic Acid, Dyslipidemia, Hypertension

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Exercise Physiology Lab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Linoleic Acid

Arm Description

Outcomes

Primary Outcome Measures

Changes in trunk adipose mass

Secondary Outcome Measures

Changes in Alpha and Gamma Tocopherol Levels
Changes in mood
Mood questionnaires will be completed at each study visit
Changes in Lipid Profile
Oil Supplementation Compliance
Plasma and red blood cell fatty acid composition will be analyzed. Returned oil containers will be weighed to estimate oil consumption.
Changes in glycemic control
Serum glucose and insulin levels will be analyzed
Changes in lean mass
Changes in visceral adipose tissue
Changes in adipocytokine levels
Adiponectin, leptin, and IL-6 will be analyzed

Full Information

First Posted
February 12, 2014
Last Updated
October 9, 2023
Sponsor
Ohio State University
Collaborators
Corr-Jensen, LLC provided some of the study oil from Arista Industries, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02063165
Brief Title
Healthy Oils for Women (HOW Study)
Acronym
HOW
Official Title
Healthy Oils for Women: Reducing Visceral Adipose Tissue in Women With Metabolic Syndrome (HOW Study)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Corr-Jensen, LLC provided some of the study oil from Arista Industries, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Safflower Oil, Linoleic Acid, Dyslipidemia, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Linoleic Acid
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
High Linoleic Safflower Oil
Intervention Description
2 tsp per day (~10g of oil)
Primary Outcome Measure Information:
Title
Changes in trunk adipose mass
Time Frame
Baseline and Week 16 (end of the study)
Secondary Outcome Measure Information:
Title
Changes in Alpha and Gamma Tocopherol Levels
Time Frame
Baseline through Week 16 (end of the study)
Title
Changes in mood
Description
Mood questionnaires will be completed at each study visit
Time Frame
Baseline through Week 16 (end of the study)
Title
Changes in Lipid Profile
Time Frame
Baseline through Week 16 (end of the Study)
Title
Oil Supplementation Compliance
Description
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)
Title
Changes in glycemic control
Description
Serum glucose and insulin levels will be analyzed
Time Frame
Baseline through Week 16 (end of the study)
Title
Changes in lean mass
Time Frame
Baseline and Week 16 (end of the study)
Title
Changes in visceral adipose tissue
Time Frame
Baseline and Week 16 (end of study)
Title
Changes in adipocytokine levels
Description
Adiponectin, leptin, and IL-6 will be analyzed
Time Frame
Baseline through Week 16 (end of the study)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha A Belury, PhD, RD
Organizational Affiliation
The Ohio State University, Department of Human Sciences, Human Nutrition Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Exercise Physiology Lab
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32923921
Citation
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.
Results Reference
derived

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Healthy Oils for Women (HOW Study)

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