Effects of Ketones Supplementation on Postprandial Lipemia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change from baseline serum triglycerides at 240 minutes
研究概览
简要总结
This study determines whether different forms of ketones supplemented prior to a meal lower the triglyceride (fat) content in the blood of overweight and obese individuals. Through a randomized crossover design, participants (n=15) will participate in each of the following three experimental groups (no treatment control, ketone ester, ketone salt), with a 5-14 day washout period between each experimental visit.
详细描述
Previous studies conducted by the investigative team in rodents show that male mice fed a diet containing 30% ketone ester (by kcals) results in greater fecal content and energy loss. While the investigators are unsure of the exact macronutrient content of the energy loss, the hypothesis is that the energy excretion is attributed to lower fat absorption. In the context of this study, it's hypothesized that ketone salts and ketone esters (both available commercially and used for a variety of health-related claims) will reduce the absorption of dietary fats leading to lower circulating triglyceride concentrations if consumed prior to a high-fat mixed meal. If the hypothesis is correct, ketones supplementation could become a valuable strategy to reduce the rise in circulating triglycerides often present in obesity. Triglyceride concentrations in the blood following a meal have been linked to development of cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Overweight or obese men as defined by a BMI of greater than or equal to 25 kg/m2, but less than 35 kg/m2
- •Between the ages of 25 and 45 years
- •Fasting triglyceride levels less than 250 mg/dL
排除标准
- •Participates in regular physical activity (≥3 days/week at 30 minutes or more per day)
- •Diagnosed cardiovascular disease or metabolic disease (type 1 or type 2 diabetes)
- •Currently following a low carbohydrate (<100 g/day) diet
- •Lost greater than or equal to 5% body weight over the last 2 months
- •Alcohol/smoking/antibiotics
结局指标
主要结局
Change from baseline serum triglycerides at 240 minutes
时间窗: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Serum levels of triglycerides in mg/DL
Change from baseline plasma glucagon-like peptide 1 at 240 minutes
时间窗: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Plasma levels of glucagon-like peptide 1 in pg/L
Change from baseline plasma leptin at 240 minutes
时间窗: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Plasma levels of leptin in ng/mL
Change from baseline serum Insulin at 240 minutes
时间窗: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Serum levels of insulin in pmol/L
Change from baseline serum B-hydroxybutyrate at 240 minutes
时间窗: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Serum levels of B-hydroxybutyrate in mmol/L
Change from baseline serum glucose at 240 minutes
时间窗: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Serum levels of glucose in mg/dL
Change from baseline plasma ghrelin at 240 minutes
时间窗: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Plasma levels of ghrelin in pg/mL
次要结局
未报告次要终点
研究者
Eric P. Plaisance
Associate Professor
University of Alabama at Birmingham