- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03202654
Effects of Corn and Coconut Oils on Lipoprotein Lipids, Insulin Sensitivity and Inflammation
A Randomized, Double-Blind, Controlled, Crossover, Pilot Trial Comparing the Effects of Corn and Coconut Oils on Fasting Lipoprotein Lipids and Markers of Insulin Sensitivity and Inflammation in Men and Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Boca Raton, Florida, United States, 33487
- MB Clinical Research
-
-
Illinois
-
Chicago, Illinois, United States, 60640
- Great Lakes Clinical Trials
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI of 18.5-34.9 kg/m2.
- Fasting LDL-C level ≥115 mg/dL and <190 mg/dL, and TG level ≤375 mg/dL.
- Judged to be in general good health on the basis of medical history and screening laboratory tests.
Exclusion Criteria:
Atherosclerotic cardiovascular disease including any of the following:
clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease [symptomatic (e.g., myocardial infarction, angina, transient ischemic attack or stroke of carotid origin) or >50% stenosis on angiography or ultrasound] or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
- History or presence of clinically important pulmonary (including uncontrolled asthma), endocrine (including type 1 or 2 diabetes mellitus), chronic inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders.
- Known allergy, sensitivity, or intolerance to any ingredients in the study products.
- Uncontrolled hypertension.
- Recent history of cancer, except for non-melanoma skin cancer.
- Recent change in body weight of ± 4.5 kg.
- Recent use of any medications intended to alter the lipid profile [e.g., statins, bile acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin (drug form), omega-3-ethyl ester drugs, or proprotein convertase subtilisin kexin type 9 inhibitors].
- Recent use of any foods or dietary supplement that might alter lipid metabolism [e.g., omega-3 fatty acid supplements (e.g., flaxseed, fish or algal oils) or fortified foods, sterol/stanol products; dietary supplements (including Metamucil® or viscous fiber-containing supplement); red rice yeast supplements; garlic supplements; soy isoflavone supplements; niacin or its analogues at doses >400 mg/d].
- Recent use of weight-loss drugs or programs or antibiotics.
- Recent daily use of non-steroidal anti-inflammatory drugs (except low-dose aspirin) or unstable use of antihypertensive medication.
- Recent use of medications that influence carbohydrate metabolism (e.g., adrenergic receptor blockers, diuretics, hypoglycemic medications, and/or systemic corticosteroids).
- Pregnant, planning to be pregnant during the study period, lactating, or of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Extreme dietary habits (e.g., vegan or very low carbohydrate diet).
- Current or recent history for drug or alcohol abuse.
- History of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
- Exposure to any non-registered drug product.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Corn Oil Intervention
Study products delivering 4 tablespoons/day corn oil will be administered for 4-week treatment period.
|
4 tablespoons/day of corn oil for 4-week treatment period.
|
ACTIVE_COMPARATOR: Coconut Oil Intervention
Study products delivering 4 tablespoons/day coconut oil will be administered for 4-week treatment period.
|
4 tablespoons/day of coconut oil for 4-week treatment period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent change in LDL-C
Time Frame: Up to 28 days for each treatment period.
|
Percent change in LDL-C from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 2-week and 4-week visits of each test period).
|
Up to 28 days for each treatment period.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent change in non-high-density lipoprotein cholesterol (Non-HDL-C).
Time Frame: Up to 28 days for each treatment period.
|
Percent change in Non-HDL-C from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 2-week and 4-week visits of each test period).
|
Up to 28 days for each treatment period.
|
Percent change in Total Cholesterol (TC)
Time Frame: Up to 28 days for each treatment period.
|
Percent change in TC from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 2-week and 4-week visits of each test period).
|
Up to 28 days for each treatment period.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent change in Triglycerides (TG)
Time Frame: Up to 28 days for each treatment period.
|
Percent change in TG from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 2-week and 4-week visits of each test period).
|
Up to 28 days for each treatment period.
|
Percent change in high-density lipoprotein cholesterol (HDL-C).
Time Frame: Up to 28 days for each treatment period.
|
Percent change in HDL-C from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 2-week and 4-week visits of each test period).
|
Up to 28 days for each treatment period.
|
Percent change in TC/ (HDL-C) ratio.
Time Frame: Up to 28 days for each treatment period.
|
Percent change in TC/ HDL-C ratio from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 2-week and 4-week visits of each test period).
|
Up to 28 days for each treatment period.
|
Disposition index [acute insulin response to intravenous glucose (AIRg) x IV-SI]
Time Frame: Up to 50 minutes - measured at baseline, and end of each treatment period.
|
Percent change (or change) from baseline to the end of each treatment period.
|
Up to 50 minutes - measured at baseline, and end of each treatment period.
|
Glucose fractional disappearance rate from t = 10-50 min (Kg)
Time Frame: Up to 50 minutes - measured at baseline, and end of each treatment period.
|
Percent change (or change) from baseline to the end of each treatment period.
|
Up to 50 minutes - measured at baseline, and end of each treatment period.
|
Homeostasis model assessments of insulin sensitivity (HOMA%S)
Time Frame: Up to 28 days of each treatment period.
|
Percent change or change from baseline to end of each treatment condition.
|
Up to 28 days of each treatment period.
|
Beta-cell function (HOMA%B)
Time Frame: Up to 28 days of each treatment period.
|
Percent change or change from baseline to end of each treatment condition.
|
Up to 28 days of each treatment period.
|
Insulin sensitivity index (IV-SI)
Time Frame: Up to 50 minutes - measured at baseline, and end of each treatment period.
|
Percent change or change from baseline to end of each treatment condition.
|
Up to 50 minutes - measured at baseline, and end of each treatment period.
|
Percent change in high-sensitivity C-reactive protein (hs-CRP)
Time Frame: Up to 28 days for each treatment period.
|
Percent change in hs-CRP from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 2-week and 4-week visits of each test period).
|
Up to 28 days for each treatment period.
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MB-1703
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Men and Women
-
USDA Beltsville Human Nutrition Research CenterCompleted
-
King's College LondonCompletedHealthy Men and WomenUnited Kingdom
-
King's College LondonLucozade Ribena SuntoryCompletedHealthy Men and WomenUnited Kingdom
-
Société des Produits Nestlé (SPN)Active, not recruitingHealthy Men and WomenSwitzerland
-
King's College LondonCompleted
-
King's College LondonLucozade Ribena SuntoryCompletedHealthy Men and WomenUnited Kingdom
-
Metabolic Technologies Inc.CompletedHealthy Men and WomenUnited States
-
King's College LondonCompletedHealthy Men and WomenUnited Kingdom
-
King's College LondonNaturex-DbsCompletedHealthy Men and WomenUnited Kingdom
Clinical Trials on Corn Oil
-
St. Luke's-Roosevelt Hospital CenterUSDA Beltsville Human Nutrition Research Center; Prosperity Organic FoodsCompletedChildhood ObesityUnited States
-
University GhentJimma University; Nutricia Research Fundation; VLIR Institutional University... and other collaboratorsCompletedChild MalnutritionEthiopia
-
University of RochesterGlaxoSmithKline; Albany College of Pharmacy and Health SciencesTerminated
-
Laval UniversityCanadian Institutes of Health Research (CIHR)Completed
-
Universiti Sains MalaysiaCompleted
-
Columbia UniversityUnited States Department of Agriculture (USDA)CompletedObesity | Overweight | Pediatric ObesityUnited States
-
National University Hospital, SingaporeWilmar InternationalEnrolling by invitationNAFLD | Non-Alcoholic Fatty Liver Disease | Non-Alcoholic SteatohepatitisSingapore
-
Gottfried Wilhelm Leibniz Universität HannoverCompleted
-
Vejle HospitalRecruitingColorectal Cancer | Peripheral NeuropathyDenmark