Clinical Trial Details

NCT ID: NCT03202654
Date Last Changed: June 27, 2017

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Healthy Men and Women

Research Study Title

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

Purpose

The objectives of this trial are to assess the effects of corn oil and coconut oil on low-density lipoprotein cholesterol (LDL-C) concentrations, and other aspects of the fasting lipoprotein lipid profile, as well as insulin sensitivity and an inflammatory marker, in men and women.

To Learn more

Recruitment Details

Gender
All
Age
18 to 79 Years
Overall Status
Recruiting
Lead Sponsor
Midwest Center for Metabolic and Cardiovascular Research
Duration
15 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 79 Years

Inclusion Criteria:

  1. BMI of 18.5-34.9 kg/m2.

  2. Fasting LDL-C level ≥115 mg/dL and < 190 mg/dL, and TG level ≤375 mg/dL.

  3. Judged to be in general good health on the basis of medical history and screening laboratory tests.

Exclusion Criteria:

  1. 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).

  1. 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.

  2. Known allergy, sensitivity, or intolerance to any ingredients in the study products.

  3. Uncontrolled hypertension.

  4. Recent history of cancer, except for non-melanoma skin cancer.

  5. Recent change in body weight of ± 4.5 kg.

  6. 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].

  7. 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].

  8. Recent use of weight-loss drugs or programs or antibiotics.

  9. Recent daily use of non-steroidal anti-inflammatory drugs (except low-dose aspirin) or unstable use of antihypertensive medication.

  10. Recent use of medications that influence carbohydrate metabolism (e.g., adrenergic receptor blockers, diuretics, hypoglycemic medications, and/or systemic corticosteroids).

  11. 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.

  12. Extreme dietary habits (e.g., vegan or very low carbohydrate diet).

  13. Current or recent history for drug or alcohol abuse.

  14. History of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).

  15. Exposure to any non-registered drug product.

Site Locations (2)

Country State City Zip Facility and Contact
United States Florida Boca Raton 33487 MB Clinical Research
Cathy Maki, RN, MSN
561-757-5766
cmaki@mbclinicalresearch.com
United States Illinois Chicago 60640 Great Lakes Clinical Trials
Steve Satek, BS, MBA
773-275-3500
ssatek@greatlakesclinicaltrials.com

Contact

Kevin C Maki, PhD
630-469-6600
E-mail:

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