Clinical trial NCT02063165: Healthy Oils for Women (HOW Study)
Official title: Healthy Oils for Women: Reducing Visceral Adipose Tissue in Women with Metabolic Syndrome (HOW Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Safflower Oil
Linoleic Acid
Dyslipidemia
Hypertension
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Corr-Jensen, LLC provided some of the study oil from Arista Industries, Inc
First posted: 2014-02-14
Enrollment: 18
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in trunk adipose mass
timeFrame: Baseline and Week 16 (end of the study)
Secondary outcomes:
measure: Changes in Alpha and Gamma Tocopherol Levels
timeFrame: Baseline through Week 16 (end of the study)
measure: Changes in mood
timeFrame: Baseline through Week 16 (end of the study)
measure: Changes in Lipid Profile
timeFrame: Baseline through Week 16 (end of the Study)
measure: Oil Supplementation Compliance
timeFrame: Baseline through Week 16 (end of the study)
measure: Changes in glycemic control
timeFrame: Baseline through Week 16 (end of the study)
measure: Changes in lean mass
timeFrame: Baseline and Week 16 (end of the study)
measure: Changes in visceral adipose tissue
timeFrame: Baseline and Week 16 (end of study)
measure: Changes in adipocytokine levels
timeFrame: Baseline through Week 16 (end of the study)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Exercise Physiology Lab
state: Ohio
Study officials:
affiliation: The Ohio State University, Department of Human Sciences, Human Nutrition Program
name: Martha A Belury, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
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.