Effect of 14 Days of Exogenous Ketone Supplementation on Glycemic Control in Type 2 Diabetes: a Randomized Placebo-controlled Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Glucose Control: Change in Fructosamine
研究概览
简要总结
Ketone bodies are a fuel source and signaling molecule that are produced by the body during prolonged fasting or if an individuals consistently eats a low-carbohydrate "keto" diet. Blood ketones can be used as a source of energy by the body, but they may also act as signals that impact the functioning of different cells in the body. Recently, the availability of ketone supplements that can be taken orally allows for raising blood ketones without having to fast or eat a "keto" diet. The investigators' studies and those of other researchers have shown that ketone supplementation can lower blood sugar without having to make any other dietary changes. Oral ingestion of ketones may therefore be an effective strategy to improve blood sugar control and influence how cells function.
The main objective of this study is to determine if consuming a ketone supplement 3 times per day (before meals) for 14 days lowers blood sugar and impacts how the body's cells function. The results of this study will be used to guide future recommendations on the utility of ketone supplements for improving health in individuals with, or at elevated risk of, type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a type 2 diabetes diagnosis from a physician
- •Have stable use of glucose-lowering medications for at least 3 months
排除标准
- •Are a competitively trained endurance athlete
- •Are actively attempting to gain or lose weight
- •Have a history of mental illness or existing neurological disease(s), cardiovascular events (i.e., heart attack, stroke) in the last 2 years
- •Have hypoglycemia, irritable bowel syndrome or inflammatory bowel disease
- •Are currently using insulin or SGLT2 inhibitors
- •Are using more than 2 classes of glucose-lowering medication
- •Are currently following a ketogenic diet or taking ketone supplements
- •Are unable to commit for a 29-day trial
- •Are unable to follow a controlled diet
结局指标
主要结局
Glucose Control: Change in Fructosamine
时间窗: Day 14 (post-intervention)
Change in glucose control (from pre-intervention Day 0) will be quantified by serum fructosamine obtained by fasting blood sample in both conditions.
次要结局
- Vascular function(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Cognition: N-back test(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Cognition: Digit-symbol substitution test(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline plasma insulin at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline circulating inflammatory cytokines at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Oxidative Burst(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Glycemic Control: 2hr postprandial hyperglycemia(Day 1 through to Day 10)
- Glycemic Control: 24hr average glucose area under the curve (AUC)(Day 1 through to Day 10)
- Change from baseline plasma free fatty acids at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Phagocytosis(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Degranulation(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Glycemic Control: Fasting glucose(Day 1 through to Day 10)
- Glycemic Control: Change in Fasting Plasma glucose(Day 14)
- Glycemic Control: Glycemic variability(Day 1 through to Day 10)
- Glycemic Control: Time in Target Range(Day 1 through to Day 10)
- Glycemic Control: HbA1c(Day 0 (pre-intervention) and Day 14 (post-intervention))
- Blood beta-hydroxybutyrate(Day 0 (pre-intervention) and Day 14 (post-intervention))
- Immune Cell Phenotyping(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Complete blood count(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Lipid Panel(Day 0 (pre-intervention) and Day 14 (post-intervention))
- Physical activity(Day 0 (pre-intervention) to Day 14 (post-intervention))
- Sedentary time(Day 0 (pre-intervention) to Day 14 (post-intervention))
- Waist circumference(Day 0 (pre-intervention) and Day 14 (post-intervention))
- Body weight(Day 0 (pre-intervention) and Day 14 (post-intervention))
- Blood pressure(Day 0 (pre-intervention) and Day 14 (post-intervention))
- Sleeping time(Day 0 (pre-intervention) to Day 14 (post-intervention))
- Resting heart rate(Day 0 (pre-intervention) and Day 14 (post-intervention))
研究者
Jonathan Little
Associate professor
University of British Columbia