Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-05 @ 2:31 PM
Study NCT ID:
NCT02611102
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2015-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Butter & MCT Oil on Lipoproteins - A RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002079', 'term': 'Butter'}, {'id': 'D003069', 'term': 'Coffee'}], 'ancestors': [{'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2015-06-10', 'studyFirstSubmitQcDate': '2015-11-18', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in apolipoprotein B', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Evaluate clinically and statistically significant changes of apoB number in healthy adults who consume coffee with butter and MCT oil.'}], 'secondaryOutcomes': [{'measure': 'non-HDL-c', 'timeFrame': '6 weeks', 'description': 'Evaluating change in non-HDL\\_c'}, {'measure': 'LDL-c', 'timeFrame': '6 weeks', 'description': 'Evaluating change in LDL-c'}, {'measure': 'triglycerides', 'timeFrame': '6 weeks', 'description': 'Evaluating change in triglycerides'}, {'measure': 'Blood pressure', 'timeFrame': '6 weeks', 'description': 'Evaluating change in blood pressure'}, {'measure': 'waist circumference', 'timeFrame': '6 weeks', 'description': 'Evaluating change in waist circumference'}, {'measure': 'Fasting Blood Glucose', 'timeFrame': '6 weeks', 'description': 'Evaluating change in fasting blood glucose'}, {'measure': 'HbA1c', 'timeFrame': '6 weeks', 'description': 'Evaluating change in HbA1c'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiovascular disease/medium-chain-triglycerides/cholesterol'], 'conditions': ['Hyperlipidemia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Research Design A prospective randomized controlled interventional study\n\nMethodology /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.\n\nPrimary objective:\n\n1\\. Evaluate clinically and statistically significant changes of apoB number in healthy adults who consume coffee with butter and MCT oil.\n\nSecondary objectives:\n\n1\\. Evaluating change in:\n\n1. non-HDL-c\n2. LDL-c\n3. triglycerides\n4. BP\n5. waist circumference\n6. FBG\n7. HbA1c\n\nExploratory objective:\n\n1\\. Change in macronutrient profiles of dietary patterns.\n\nOur 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. DoD healthcare beneficiaries\n2. willing to drink 2 to 4 cups of coffee daily\n3. between the ages of 18 to 45\n4. serum LDL-c \\< 160,\n5. non-HDL-c \\< 190\n6. apoB \\< 120\n\nExclusion Criteria:\n\n1. BMI \\> 30kg/m2 or \\< 20kg/m2 or waist circumference \\> 102cm (males) or 88cm (females)\n2. Triglycerides \\> 150\n3. Hypertension defined as SBP \\> 150, DBP \\> 90 or on treatment for high blood pressure\n4. Chronic liver disease defined by any clinical or a history of serum AST or ALT \\> 3 times ULN\n5. Kidney disease defined as a GFR \\<90 ml/min or history of nephritic syndrome\n6. Impaired glucose metabolism defined as HbA1c \\> 5.6, FBG \\> 99, or 2-hour OGTT \\> 139\n7. Any known malignancy\n8. Known malabsorption disorder to include inflammatory bowel disease, celiac disease, cystic fibrosis, history of gastric bypass\n9. Hypothyroidism per lab evaluation at baseline\n10. Pregnancy\n11. Polycystic Ovary Syndrome or irregular menstrual periods\n12. 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\n\n a. If on hormonal contraceptives, lipid panel must be stable over the past 12-24 months\n13. Cushing's syndrome per medical history or clinical suspicion\n14. HIV per medical history\n15. Chronic Inflammatory Disorders such as, but not limited to, SLE, RA, IBD per medical history\n16. History of tobacco use within the previous 12 months to include cigarettes, e-cigarettes, chewing tobacco, cigars, and pipes.\n17. History of marijuana use within the previous 12 months\n18. Active intentional weight loss of over 5% in the past 3 months"}, 'identificationModule': {'nctId': 'NCT02611102', 'briefTitle': 'Effect of Butter & MCT Oil on Lipoproteins - A RCT', 'organization': {'class': 'FED', 'fullName': 'Walter Reed National Military Medical Center'}, 'officialTitle': 'Effects of Daily Butter & Medium-Chain Triglyceride Oil on Lipoproteins When Added to Baseline Diet a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '404482-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MCT oil + Butter in Coffee', 'description': 'This group will be provided with MCT oil and butter to add to their daily coffee intake.', 'interventionNames': ['Dietary Supplement: MCT oil + Butter in Coffee']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low calorie coffee', 'description': 'This group will continue to drink their normal daily coffee with \\< 50kcal of creamer and/or sweetener.', 'interventionNames': ['Dietary Supplement: MCT oil + Butter in Coffee']}], 'interventions': [{'name': 'MCT oil + Butter in Coffee', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Low calorie coffee', 'MCT oil + Butter in Coffee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20889-5600', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Walter Reed National Military Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Thanh D Hoang, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'WRNMMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walter Reed National Military Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}