HyperlipidemiaNCT02611102
Effect of Butter & MCT Oil on Lipoproteins - A RCT
A study testing MCT oil + Butter in Coffee in people with Hyperlipidemia, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
Determine the effects on lipoprotein profiles of high dose concentrated dietary SFA (saturated fatty acids) (from MCT (medium-chain triglyceride) oil + butter) in combination added to coffee. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- MCT oil + Butter in Coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2016to Mar 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- DoD healthcare beneficiaries
- willing to drink 2 to 4 cups of coffee daily
- between the ages of 18 to 45
- serum LDL-c < 160,
- non-HDL-c < 190
- apoB < 120
Who cannot join
- BMI > 30kg/m2 or < 20kg/m2 or waist circumference > 102cm (males) or 88cm (females)
- Triglycerides > 150
- Hypertension defined as SBP > 150, DBP > 90 or on treatment for high blood pressure
- Chronic liver disease defined by any clinical or a history of serum AST or ALT > 3 times ULN
- Kidney disease defined as a GFR <90 ml/min or history of nephritic syndrome
- Impaired glucose metabolism defined as HbA1c > 5.6, FBG > 99, or 2-hour OGTT > 139
Show all 19Show fewer
- Any known malignancy
- Known malabsorption disorder to include inflammatory bowel disease, celiac disease, cystic fibrosis, history of gastric bypass
- Hypothyroidism per lab evaluation at baseline
- Pregnancy
- Polycystic Ovary Syndrome or irregular menstrual periods
- Subjects taking certain medications such as glucocorticoids, immunosuppressants (cyclosporine, sirolimus, etc.), tamoxifen, androgens, antipsychotics, hydrochlorothiazide, retinoids, beta-blockers, statins, bile acid sequestrants, niacin, fibrates, ezetimibe, high dose fish oil (>1gm/day epa + dha), or any other supplement or pharmacologic agent known to alter lipoproteins
- If on hormonal contraceptives, lipid panel must be stable over the past 12-24 months
- Cushing's syndrome per medical history or clinical suspicion
- HIV per medical history
- Chronic Inflammatory Disorders such as, but not limited to, SLE, RA, IBD per medical history
- History of tobacco use within the previous 12 months to include cigarettes, e-cigarettes, chewing tobacco, cigars, and pipes.
- History of marijuana use within the previous 12 months
- Active intentional weight loss of over 5% in the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
About this study
Official title: Effects of Daily Butter & Medium-Chain Triglyceride Oil on Lipoproteins When Added to Baseline Diet a Randomized Controlled Trial
Determine the effects on lipoprotein profiles of high dose concentrated dietary SFA (saturated fatty acids) (from MCT (medium-chain triglyceride) oil + butter) in combination added to coffee. The study will be conducted as a RCT in healthy adults without cardiometabolic disease or conditions that influence lipoprotein metabolism or other specific dietary recommendations.
Read the detailed description
Research Design A prospective randomized controlled interventional study
Methodology /Technical Approach A total of up to 60 subjects will be recruited to allow for completion of the study by a minimum of 17 subjects per arm. Subjects will be randomized to one of two groups in a 1:1 ratio. Recruited subjects will be adult coffee drinkers between the ages of 18-45 without hyperlipidemia and without criteria for diabetes or pre-diabetes. Subjects will have baseline weight, waist circumference (WC), and blood-pressure (BP) measurements obtained. Subjects will have baseline fasting lipids,, CMP,HbA1c,TSH,and hsCRP. The subjects will be stratified by gender and randomized to receive one of two dietary regimens: 1) coffee (< 50 kcal of added creamer/sweetener) or 2) coffee with butter + medium-chain triglyceride (MCT) oil combination (2 tbsp. MCT containing 230kcal and 28gm fat+ 2 tbsp butter containing 200kcal and 22gm fat). The drink will be consumed daily over a 4 week period. Dietary history will be evaluated by via the ASA24website (http://appliedresearch.cancer.gov/asa24/). At 6 and 12 weeks post-consent, baseline labs will be repeated. The primary outcome is change in apolipoprotein B between groups. Secondary outcomes include changes in lipids, WC, BP, HbA1c, and FBG. Exploratory analysis will include changes in dietary macronutrient load and subgroup analysis of effects related to dietary patterns.
Primary objective:
- Evaluate clinically and statistically significant changes of apoB number in healthy adults who consume coffee with butter and MCT oil.
Secondary objectives:
- Evaluating change in:
- non-HDL-c
- LDL-c
- triglycerides
- BP
- waist circumference
- FBG
- HbA1c
Exploratory objective:
- Change in macronutrient profiles of dietary patterns.
Our null hypothesis is that the addition of butter and medium-chain triglyceride oil at proposed doses has no clinically significant effects on atherogenic lipoproteins, namely apo lipoprotein B particles (apoB).
- Conditions
- Hyperlipidemia
- Being tested
- MCT oil + Butter in Coffee
- Keywords
- cardiovascular disease/medium-chain-triglycerides/cholesterol
- Medical subject headings
- Hyperlipidemias, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCT oil + Butter in CoffeeDietary supplement
2 tablespoons medium-chain triglyceride oil + 2 tablespoons butter added to 2-4 cups of coffee similar to their usual intake prior to 1200 daily over a 4 week period after a 2 week run-in phase during which the doses of butter and MCT oil will be titrated up (1 Tbsp. of each butter + MCT x 5 days, 2 Tbsp. butter + 1 Tbsp. MCT x 5 days, then 2 Tbsp. of each x 4 days) followed by 6 weeks of washout without treatment.
| Study group | Role | What they receive |
|---|---|---|
| MCT oil + Butter in Coffee | Experimental | This group will be provided with MCT oil and butter to add to their daily coffee intake. Receives: Dietary Supplement: MCT oil + Butter in Coffee |
| Low calorie coffee | Placebo comparator | This group will continue to drink their normal daily coffee with < 50kcal of creamer and/or sweetener. Receives: Dietary Supplement: MCT oil + Butter in Coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in apolipoprotein B
Evaluate clinically and statistically significant changes of apoB number in healthy adults who consume coffee with butter and MCT oil.
Measured: Baseline and 6 weeks
Secondary outcomes (7)
non-HDL-c
Evaluating change in non-HDL_c
Measured: 6 weeks
LDL-c
Evaluating change in LDL-c
Measured: 6 weeks
triglycerides
Evaluating change in triglycerides
Measured: 6 weeks
Blood pressure
Evaluating change in blood pressure
Measured: 6 weeks
waist circumference
Evaluating change in waist circumference
Measured: 6 weeks
Fasting Blood Glucose
Evaluating change in fasting blood glucose
Measured: 6 weeks
HbA1c
Evaluating change in HbA1c
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start8 Mar 2016
- Primary completionMar 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Thanh D Hoang, DO, Principal investigator, WRNMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611102
- Sponsor's protocol ID
- 404482-2
- Status last verified
- Apr 2023
- First submitted
- 10 Jun 2015
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daily Butter & Medium-Chain Triglyceride Oil on Lipoproteins When Added to Baseline Diet a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02611102
- Acronym / sponsor ID
- 404482-2
- Conditions
- Hyperlipidemia
- Keywords
- cardiovascular disease/medium-chain-triglycerides/cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 20 Nov 2015 (estimated)
- 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.
Determine the effects on lipoprotein profiles of high dose concentrated dietary SFA (saturated fatty acids) (from MCT (medium-chain triglyceride) oil + butter) in combination added to coffee. The study will be conducted as a RCT in healthy adults without cardiometabolic disease or conditions that influence lipoprotein metabolism or other specific dietary recommendations.
Detailed description
Research Design A prospective randomized controlled interventional study
Methodology /Technical Approach A total of up to 60 subjects will be recruited to allow for completion of the study by a minimum of 17 subjects per arm. Subjects will be randomized to one of two groups in a 1:1 ratio. Recruited subjects will be adult coffee drinkers between the ages of 18-45 without hyperlipidemia and without criteria for diabetes or pre-diabetes. Subjects will have baseline weight, waist circumference (WC), and blood-pressure (BP) measurements obtained. Subjects will have baseline fasting lipids,, CMP,HbA1c,TSH,and hsCRP. The subjects will be stratified by gender and randomized to receive one of two dietary regimens: 1) coffee (< 50 kcal of added creamer/sweetener) or 2) coffee with butter + medium-chain triglyceride (MCT) oil combination (2 tbsp. MCT containing 230kcal and 28gm fat+ 2 tbsp butter containing 200kcal and 22gm fat). The drink will be consumed daily over a 4 week period. Dietary history will be evaluated by via the ASA24website (http://appliedresearch.cancer.gov/asa24/). At 6 and 12 weeks post-consent, baseline labs will be repeated. The primary outcome is change in apolipoprotein B between groups. Secondary outcomes include changes in lipids, WC, BP, HbA1c, and FBG. Exploratory analysis will include changes in dietary macronutrient load and subgroup analysis of effects related to dietary patterns.
Primary objective:
- Evaluate clinically and statistically significant changes of apoB number in healthy adults who consume coffee with butter and MCT oil.
Secondary objectives:
- Evaluating change in:
- non-HDL-c
- LDL-c
- triglycerides
- BP
- waist circumference
- FBG
- HbA1c
Exploratory objective:
- Change in macronutrient profiles of dietary patterns.
Our null hypothesis is that the addition of butter and medium-chain triglyceride oil at proposed doses has no clinically significant effects on atherogenic lipoproteins, namely apo lipoprotein B particles (apoB).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCT oil + Butter in Coffee | Experimental | Dietary Supplement: MCT oil + Butter in CoffeeThis group will be provided with MCT oil and butter to add to their daily coffee intake. |
| Low calorie coffee | Placebo comparator | Dietary Supplement: MCT oil + Butter in CoffeeThis group will continue to drink their normal daily coffee with < 50kcal of creamer and/or sweetener. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- DoD healthcare beneficiaries
- willing to drink 2 to 4 cups of coffee daily
- between the ages of 18 to 45
- serum LDL-c < 160,
- non-HDL-c < 190
Key exclusion criteria (19 listed)
- BMI > 30kg/m2 or < 20kg/m2 or waist circumference > 102cm (males) or 88cm (females)
- Triglycerides > 150
- Hypertension defined as SBP > 150, DBP > 90 or on treatment for high blood pressure
- Chronic liver disease defined by any clinical or a history of serum AST or ALT > 3 times ULN
- Kidney disease defined as a GFR <90 ml/min or history of nephritic syndrome
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 |
|---|---|---|
| MCT oil + Butter in Coffee2 tablespoons medium-chain triglyceride oil + 2 tablespoons butter added to 2-4 cups of coffee similar to their usual intake prior to 1200 daily over a 4 week period after a 2 week run-in phase during which the doses of butter and MCT oil will be titrated up (1 Tbsp. of each butter + MCT x 5 days, 2 Tbsp. butter + 1 Tbsp. MCT x 5 days, then 2 Tbsp. of each x 4 days) followed by 6 weeks of washout without treatment. | Dietary supplement | Low calorie coffee, MCT oil + Butter in Coffee |
Primary outcome
Changes in apolipoprotein B
Time frame: Baseline and 6 weeks
Evaluate clinically and statistically significant changes of apoB number in healthy adults who consume coffee with butter and MCT oil.
7 secondary outcomes
non-HDL-c
Time frame: 6 weeks
LDL-c
Time frame: 6 weeks
triglycerides
Time frame: 6 weeks
Blood pressure
Time frame: 6 weeks
waist circumference
Time frame: 6 weeks
Fasting Blood Glucose
Time frame: 6 weeks
HbA1c
Time frame: 6 weeks
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 28 Apr 2023.
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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.
Thanh D Hoang, DO principal investigator
WRNMMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCT oil + Butter in Coffee in people with Hyperlipidemia, run by Walter Reed National Military Medical Center at 1 site 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 6 inclusion and 19 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Changes in apolipoprotein B (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2023.