NCT02063165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

February 12, 2014

Last Update Submit

October 27, 2024

Conditions

Metabolic Syndrome

Keywords

Safflower OilLinoleic AcidDyslipidemiaHypertension

Outcome Measures

Primary Outcomes (1)

  • Changes in trunk adipose mass

    Baseline and Week 16 (end of the study)

Secondary Outcomes (8)

  • Changes in Alpha and Gamma Tocopherol Levels

    Baseline through Week 16 (end of the study)

  • Changes in mood

    Baseline through Week 16 (end of the study)

  • Changes in Lipid Profile

    Baseline through Week 16 (end of the Study)

  • Oil Supplementation Compliance

    Baseline through Week 16 (end of the study)

  • Changes in glycemic control

    Baseline through Week 16 (end of the study)

  • +3 more secondary outcomes

Study Arms (1)

Linoleic Acid

EXPERIMENTAL
Dietary Supplement: High Linoleic Safflower Oil

Interventions

High Linoleic Safflower OilDIETARY_SUPPLEMENT

2 tsp per day (\~10g of oil)

Linoleic Acid

Eligibility Criteria

Age50 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Exercise Physiology Lab

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • 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.

    PMID: 32923921DERIVED

MeSH Terms

Conditions

Metabolic SyndromeDyslipidemiasHypertension

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Martha A Belury, PhD, RD

    The Ohio State University, Department of Human Sciences, Human Nutrition Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Carol S. Kennedy Professor of Nutrition

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 14, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations

US(1)