Effects of Corn and Coconut Oils on Lipoprotein Lipids, Insulin Sensitivity and Inflammation

NCT03202654 | Completed

• 1 other identifier: MB-1703
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy Men and Women

Outcome Measures

Primary Outcomes (1)

• Percent change in LDL-C

  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 Outcomes (2)

• Percent change in non-high-density lipoprotein cholesterol (Non-HDL-C).

  Up to 28 days for each treatment period.

• Percent change in Total Cholesterol (TC)

  Up to 28 days for each treatment period.

Other Outcomes (9)

• Percent change in Triglycerides (TG)

  Up to 28 days for each treatment period.

• Percent change in high-density lipoprotein cholesterol (HDL-C).

  Up to 28 days for each treatment period.

• Percent change in TC/ (HDL-C) ratio.

  Up to 28 days for each treatment period.

Study Arms (2)

Corn Oil Intervention

EXPERIMENTAL

Study products delivering 4 tablespoons/day corn oil will be administered for 4-week treatment period.

Other: Corn Oil

Coconut Oil Intervention

ACTIVE COMPARATOR

Study products delivering 4 tablespoons/day coconut oil will be administered for 4-week treatment period.

Other: Coconut Oil

Interventions

Corn Oil OTHER

4 tablespoons/day of corn oil for 4-week treatment period.

Corn Oil Intervention

Coconut Oil OTHER

4 tablespoons/day of coconut oil for 4-week treatment period.

Coconut Oil Intervention

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• ACH Food Companies, Inc.: collaborator

Study Sites (2)

MB Clinical Research

Boca Raton, Florida, 33487, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Related Publications (1)

• Maki KC, Hasse W, Dicklin MR, Bell M, Buggia MA, Cassens ME, Eren F. Corn Oil Lowers Plasma Cholesterol Compared with Coconut Oil in Adults with Above-Desirable Levels of Cholesterol in a Randomized Crossover Trial. J Nutr. 2018 Oct 1;148(10):1556-1563. doi: 10.1093/jn/nxy156.

  PMID: 30204921 DERIVED

MeSH Terms

Interventions

Corn Oil; Coconut Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: June 22, 2017
• Primary Completion: October 10, 2017
• Study Completion: October 31, 2017
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

US (2)