Metabolic SyndromeHOWNCT02063165
Healthy Oils for Women (HOW Study)
A study testing High Linoleic Safflower Oil in people with Metabolic Syndrome, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women only
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- High Linoleic Safflower Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Exercise Physiology Lab
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- High Linoleic Safflower Oil
- Keywords
- Safflower Oil, Linoleic Acid, Dyslipidemia, Hypertension
- Medical subject headings
- Metabolic Syndrome, Dyslipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Linoleic Safflower OilDietary supplement
2 tsp per day (~10g of oil)
| Study group | Role | What they receive |
|---|---|---|
| Linoleic Acid | Experimental | Not described Receives: Dietary Supplement: High Linoleic Safflower Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in trunk adipose mass
Measured: Baseline and Week 16 (end of the study)
Secondary outcomes (8)
Changes in Alpha and Gamma Tocopherol Levels
Measured: Baseline through Week 16 (end of the study)
Changes in mood
Mood questionnaires will be completed at each study visit
Measured: Baseline through Week 16 (end of the study)
Changes in Lipid Profile
Measured: 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.
Measured: Baseline through Week 16 (end of the study)
Changes in glycemic control
Serum glucose and insulin levels will be analyzed
Measured: Baseline through Week 16 (end of the study)
Changes in lean mass
Measured: Baseline and Week 16 (end of the study)
Changes in visceral adipose tissue
Measured: Baseline and Week 16 (end of study)
Changes in adipocytokine levels
Adiponectin, leptin, and IL-6 will be analyzed
Measured: Baseline through Week 16 (end of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Corr-Jensen, LLC provided some of the study oil from Arista Industries, Inc
- Responsible party
- Principal investigator, Martha Belury, Ohio State University
- Investigators
- Martha A Belury, PhD, RD, Principal investigator, The Ohio State University, Department of Human Sciences, Human Nutrition Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063165
- Sponsor's protocol ID
- 2012H0259
- Other IDs
- 2011-039
- Acronym
- HOW
- Status last verified
- Oct 2024
- First submitted
- 12 Feb 2014
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 32923921
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Oils for Women: Reducing Visceral Adipose Tissue in Women with Metabolic Syndrome (HOW Study)
- ClinicalTrials.gov ID
- NCT02063165
- Acronym / sponsor ID
- HOW / 2012H0259
- Conditions
- Metabolic Syndrome
- Keywords
- Safflower Oil, Linoleic Acid, Dyslipidemia, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Corr-Jensen, LLC provided some of the study oil from Arista Industries, Inc
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linoleic Acid | Experimental | Dietary Supplement: High Linoleic Safflower Oil |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female
- Post-menopausal (cessation of menses ≥12 months)
- Age ≥ 50 and ≤ 69 years
- At Least one of the following metabolic syndrome criteria
- Obese (BMI ≥ 30 kg/m² and ≤ 55 kg/m²)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Linoleic Safflower Oil2 tsp per day (~10g of oil) | Dietary supplement | Linoleic Acid |
Primary outcome
Changes in trunk adipose mass
Time frame: Baseline and Week 16 (end of the study)
8 secondary outcomes
Changes in Alpha and Gamma Tocopherol Levels
Time frame: Baseline through Week 16 (end of the study)
Changes in mood
Time frame: Baseline through Week 16 (end of the study)
Changes in Lipid Profile
Time frame: Baseline through Week 16 (end of the Study)
Oil Supplementation Compliance
Time frame: Baseline through Week 16 (end of the study)
Changes in glycemic control
Time frame: Baseline through Week 16 (end of the study)
Changes in lean mass
Time frame: Baseline and Week 16 (end of the study)
Changes in visceral adipose tissue
Time frame: Baseline and Week 16 (end of study)
Changes in adipocytokine levels
Time frame: Baseline through Week 16 (end of the study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Derived from this study: PubMed 32923921Cole 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.
Related trials for Metabolic Syndrome
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha A Belury, PhD, RD principal investigator
The Ohio State University, Department of Human Sciences, Human Nutrition Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Linoleic Safflower Oil in people with Metabolic Syndrome, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in trunk adipose mass (time frame: Baseline and Week 16 (end of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02063165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.