Effects of Daily Butter & Medium-Chain Triglyceride Oil on Lipoproteins When Added to Baseline Diet a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in apolipoprotein B
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
- •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
- •a. 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
结局指标
主要结局
Changes in apolipoprotein B
时间窗: Baseline and 6 weeks
Evaluate clinically and statistically significant changes of apoB number in healthy adults who consume coffee with butter and MCT oil.
次要结局
- waist circumference(6 weeks)
- LDL-c(6 weeks)
- Fasting Blood Glucose(6 weeks)
- non-HDL-c(6 weeks)
- Blood pressure(6 weeks)
- HbA1c(6 weeks)
- triglycerides(6 weeks)