Healthy Men and WomenNCT03202654
Effects of Corn and Coconut Oils on Lipoprotein Lipids, Insulin Sensitivity and Inflammation
A study testing Corn Oil and Coconut Oil in people with Healthy Men and Women, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Men and Women
- What is being tested?
- Corn Oil and Coconut Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jun 2017to 31 Oct 2017
- 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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MB Clinical Research
Boca Raton, Florida, 33487
Great Lakes Clinical Trials
Chicago, Illinois, 60640
About this study
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
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.
Read the 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.
- Conditions
- Healthy Men and Women
- Being tested
- Corn Oil, Coconut Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corn OilOther
4 tablespoons/day of corn oil for 4-week treatment period.
Coconut OilOther
4 tablespoons/day of coconut oil for 4-week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Corn Oil Intervention | Experimental | Study products delivering 4 tablespoons/day corn oil will be administered for 4-week treatment period. Receives: Other: Corn Oil |
| Coconut Oil Intervention | Active comparator | Study products delivering 4 tablespoons/day coconut oil will be administered for 4-week treatment period. Receives: Other: Coconut Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 28 days for each treatment period.
Secondary outcomes (2)
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).
Measured: Up to 28 days for each treatment 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).
Measured: Up to 28 days for each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start22 Jun 2017
- Primary completion10 Oct 2017
- Study completion31 Oct 2017
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 Healthy Men and WomenStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- ACH Food Companies, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202654
- Sponsor's protocol ID
- MB-1703
- Status last verified
- May 2018
- First submitted
- 26 Jun 2017
- Last updated
- 15 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30204921
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03202654
- Acronym / sponsor ID
- MB-1703
- Conditions
- Healthy Men and Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- ACH Food Companies, Inc.
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 28 Jun 2017 (actual)
- 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corn Oil Intervention | Experimental | Other: Corn OilStudy products delivering 4 tablespoons/day corn oil will be administered for 4-week treatment period. |
| Coconut Oil Intervention | Active comparator | Other: Coconut OilStudy products delivering 4 tablespoons/day coconut oil will be administered for 4-week treatment period. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| Corn Oil4 tablespoons/day of corn oil for 4-week treatment period. | Other | Corn Oil Intervention |
| Coconut Oil4 tablespoons/day of coconut oil for 4-week treatment period. | Other | Coconut Oil Intervention |
Primary outcome
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).
2 secondary outcomes
Percent change in non-high-density lipoprotein cholesterol (Non-HDL-C).
Time frame: Up to 28 days for each treatment period.
Percent change in Total Cholesterol (TC)
Time frame: Up to 28 days for each treatment period.
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 15 May 2018.
- Derived from this study: PubMed 30204921Maki 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corn Oil and Coconut Oil in people with Healthy Men and Women, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites 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 3 inclusion and 17 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 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Percent change in LDL-C (time frame: Up to 28 days for each treatment period.). 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 NCT03202654, 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 15 May 2018.