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Trial record 4 of 11 for:    mct oil

Effect of Butter & MCT Oil on Lipoproteins - A RCT

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ClinicalTrials.gov Identifier: NCT02611102
Recruitment Status : Unknown
Verified September 2016 by Walter Reed National Military Medical Center.
Recruitment status was:  Recruiting
First Posted : November 20, 2015
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Walter Reed National Military Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Dietary Supplement: MCT oil + Butter in Coffee Not Applicable

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:

1. Evaluate clinically and statistically significant changes of apoB number in healthy adults who consume coffee with butter and MCT oil.

Secondary objectives:

1. Evaluating change in:

  1. non-HDL-c
  2. LDL-c
  3. triglycerides
  4. BP
  5. waist circumference
  6. FBG
  7. HbA1c

Exploratory objective:

1. 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Daily Butter & Medium-Chain Triglyceride Oil on Lipoproteins When Added to Baseline Diet a Randomized Controlled Trial
Study Start Date : March 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: MCT oil + Butter in Coffee
This group will be provided with MCT oil and butter to add to their daily coffee intake.
Dietary Supplement: MCT oil + Butter in Coffee
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.

Placebo Comparator: Low calorie coffee
This group will continue to drink their normal daily coffee with < 50kcal of creamer and/or sweetener.
Dietary Supplement: MCT oil + Butter in Coffee
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.




Primary Outcome Measures :
  1. Changes in apolipoprotein B [ Time Frame: Baseline and 6 weeks ]

Secondary Outcome Measures :
  1. non-HDL-c [ Time Frame: 6 weeks ]
  2. LDL-c [ Time Frame: 6 weeks ]
  3. triglycerides [ Time Frame: 6 weeks ]
  4. Blood pressure [ Time Frame: 6 weeks ]
  5. waist circumference [ Time Frame: 6 weeks ]
  6. Fasting Blood Glucose [ Time Frame: 6 weeks ]
  7. HbA1c [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. DoD healthcare beneficiaries
  2. willing to drink 2 to 4 cups of coffee daily
  3. between the ages of 18 to 45
  4. serum LDL-c < 160,
  5. non-HDL-c < 190
  6. apoB < 120

Exclusion Criteria:

  1. BMI > 30kg/m2 or < 20kg/m2 or waist circumference > 102cm (males) or 88cm (females)
  2. Triglycerides > 150
  3. Hypertension defined as SBP > 150, DBP > 90 or on treatment for high blood pressure
  4. Chronic liver disease defined by any clinical or a history of serum AST or ALT > 3 times ULN
  5. Kidney disease defined as a GFR <90 ml/min or history of nephritic syndrome
  6. Impaired glucose metabolism defined as HbA1c > 5.6, FBG > 99, or 2-hour OGTT > 139
  7. Any known malignancy
  8. Known malabsorption disorder to include inflammatory bowel disease, celiac disease, cystic fibrosis, history of gastric bypass
  9. Hypothyroidism per lab evaluation at baseline
  10. Pregnancy
  11. Polycystic Ovary Syndrome or irregular menstrual periods
  12. 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

    a. If on hormonal contraceptives, lipid panel must be stable over the past 12-24 months

  13. Cushing's syndrome per medical history or clinical suspicion
  14. HIV per medical history
  15. Chronic Inflammatory Disorders such as, but not limited to, SLE, RA, IBD per medical history
  16. History of tobacco use within the previous 12 months to include cigarettes, e-cigarettes, chewing tobacco, cigars, and pipes.
  17. History of marijuana use within the previous 12 months
  18. Active intentional weight loss of over 5% in the past 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611102


Contacts
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Contact: Karl Z Nadolsky, DO 6168866205 karl.z.nadolsky.mil@mail.mil
Contact: Sara J Salkind, MA 3013192873 sara.j.salkind.ctr@mail.mil

Locations
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United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Sub-Investigator: Henry Burch, MD         
Principal Investigator: Karl Nadolsky, DO         
Principal Investigator: Alicia L Warnock, MD         
Principal Investigator: Todd Villines, MD         
Principal Investigator: Matthew Jezior, MD         
Sponsors and Collaborators
Walter Reed National Military Medical Center
Investigators
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Principal Investigator: Karl Z Nadolsky, DO WRNMMC

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Responsible Party: Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT02611102     History of Changes
Other Study ID Numbers: 404482-2
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases