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

Primary Purpose

Healthy Men and Women

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Corn Oil
Coconut Oil
Sponsored by
Midwest Center for Metabolic and Cardiovascular Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Healthy Men and Women

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

  2. 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.
  3. Known allergy, sensitivity, or intolerance to any ingredients in the study products.
  4. Uncontrolled hypertension.
  5. Recent history of cancer, except for non-melanoma skin cancer.
  6. Recent change in body weight of ± 4.5 kg.
  7. 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].
  8. 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].
  9. Recent use of weight-loss drugs or programs or antibiotics.
  10. Recent daily use of non-steroidal anti-inflammatory drugs (except low-dose aspirin) or unstable use of antihypertensive medication.
  11. Recent use of medications that influence carbohydrate metabolism (e.g., adrenergic receptor blockers, diuretics, hypoglycemic medications, and/or systemic corticosteroids).
  12. 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.
  13. Extreme dietary habits (e.g., vegan or very low carbohydrate diet).
  14. Current or recent history for drug or alcohol abuse.
  15. History of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
  16. Exposure to any non-registered drug product.

Sites / Locations

  • MB Clinical Research
  • Great Lakes Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Corn Oil Intervention

Coconut Oil Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Percent change in non-high-density lipoprotein cholesterol (Non-HDL-C).
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).
Percent change in Total Cholesterol (TC)
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).

Full Information

First Posted
June 26, 2017
Last Updated
May 11, 2018
Sponsor
Midwest Center for Metabolic and Cardiovascular Research
Collaborators
ACH Food Companies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03202654
Brief Title
Effects of Corn and Coconut Oils on Lipoprotein Lipids, Insulin Sensitivity and Inflammation
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 22, 2017 (Actual)
Primary Completion Date
October 10, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Midwest Center for Metabolic and Cardiovascular Research
Collaborators
ACH Food Companies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
This is a randomized, crossover, pilot study that includes two screening visits and two 4-week test periods, separated by a 3-week washout. Subjects will consume study products providing 4 tablespoons oil/day of either corn oil or coconut oil replacing the same amount of oil in the background diet. Subjects will otherwise be encouraged to follow their habitual diet during both treatment periods. They will receive diet instructions on the incorporation of food substitutions during the test periods to maintain habitual energy intake. Subjects will record daily study product intake and compliance in a Daily Log. An intravenous glucose tolerance test (IVGTT) will be completed at baseline and the end of each treatment period for evaluation of insulin sensitivity. Fasting blood samples will be collected for lipid profile and high-sensitivity C-reactive protein (hs-CRP) measurements at all visits. Assessments of vital signs and body weight, review of concomitant medication/supplement use and inclusion and exclusion criteria for relevant changes, and evaluation of adverse effects will be performed throughout the study. Compliance will be assessed using the Daily Log intake percentages as the primary source.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Men and Women

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corn Oil Intervention
Arm Type
Experimental
Arm Description
Study products delivering 4 tablespoons/day corn oil will be administered for 4-week treatment period.
Arm Title
Coconut Oil Intervention
Arm Type
Active Comparator
Arm Description
Study products delivering 4 tablespoons/day coconut oil will be administered for 4-week treatment period.
Intervention Type
Other
Intervention Name(s)
Corn Oil
Intervention Description
4 tablespoons/day of corn oil for 4-week treatment period.
Intervention Type
Other
Intervention Name(s)
Coconut Oil
Intervention Description
4 tablespoons/day of coconut oil for 4-week treatment period.
Primary Outcome Measure Information:
Title
Percent change in LDL-C
Description
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).
Time Frame
Up to 28 days for each treatment period.
Secondary Outcome Measure Information:
Title
Percent change in non-high-density lipoprotein cholesterol (Non-HDL-C).
Description
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).
Time Frame
Up to 28 days for each treatment period.
Title
Percent change in Total Cholesterol (TC)
Description
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).
Time Frame
Up to 28 days for each treatment period.
Other Pre-specified Outcome Measures:
Title
Percent change in Triglycerides (TG)
Description
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).
Time Frame
Up to 28 days for each treatment period.
Title
Percent change in high-density lipoprotein cholesterol (HDL-C).
Description
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).
Time Frame
Up to 28 days for each treatment period.
Title
Percent change in TC/ (HDL-C) ratio.
Description
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).
Time Frame
Up to 28 days for each treatment period.
Title
Disposition index [acute insulin response to intravenous glucose (AIRg) x IV-SI]
Description
Percent change (or change) from baseline to the end of each treatment period.
Time Frame
Up to 50 minutes - measured at baseline, and end of each treatment period.
Title
Glucose fractional disappearance rate from t = 10-50 min (Kg)
Description
Percent change (or change) from baseline to the end of each treatment period.
Time Frame
Up to 50 minutes - measured at baseline, and end of each treatment period.
Title
Homeostasis model assessments of insulin sensitivity (HOMA%S)
Description
Percent change or change from baseline to end of each treatment condition.
Time Frame
Up to 28 days of each treatment period.
Title
Beta-cell function (HOMA%B)
Description
Percent change or change from baseline to end of each treatment condition.
Time Frame
Up to 28 days of each treatment period.
Title
Insulin sensitivity index (IV-SI)
Description
Percent change or change from baseline to end of each treatment condition.
Time Frame
Up to 50 minutes - measured at baseline, and end of each treatment period.
Title
Percent change in high-sensitivity C-reactive protein (hs-CRP)
Description
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).
Time Frame
Up to 28 days for each treatment period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
MB Clinical Research
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30204921
Citation
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.
Results Reference
derived

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

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