The Effects of Exogenous Ketone Supplementation on Cardiovascular Function and Glucose Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Glucose control
研究概览
简要总结
Post-prandial hyperglycemic excursions induce a cascade of deleterious effects on the body, including increased inflammation, production of reactive oxygen species, and impaired cardiovascular function. Ingestion of an exogenous oral ketone supplement blunts hyperglycemia in response to an oral glucose tolerance test. Accordingly, it is hypothesized that exogenous ketone supplement ingestion prior to a meal could be an effective strategy for blunting postprandial hyperglycemia. Therefore, the purpose of this study is to investigate the effect of short-term (14-days) pre-meal exogenous ketone supplementation on glucose control, cardiovascular function, inflammation, and oxidative stress in individuals at an 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
- Prevention
- 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
- •Elevated waist circumference (>102 cm for males, >88 cm for females) and/or Obesity (BMI > 30 kg/m2) and/or Diagnoses of prediabetes based on A1C (5.7-6.4%) and/or fasting plasma glucose (5.6-6.9 mmol/l) using ADA criteria
排除标准
- •Competitively trained endurance athlete
- •Actively attempting to lose weight
- •History of mental illness or existing neurological disease(s)
- •Previous cardiovascular events (i.e., heart attack, stroke)
- •Diagnoses of diabetes
- •Hypoglycemia
- •Irritable bowel syndrome or inflammatory bowel disease
- •Taking medication that may interfere with insulin sensitivity
- •Currently following a ketogenic diet or taking ketone supplements
- •Unable to commit for 2 separate 14-day trials and unable to follow a controlled diet
研究组 & 干预措施
Experimental
- Participants will consume 20 g of an active oral exogenous ketone monoester supplement 15 minutes prior to each meal of the day for a 14-day period.
- Pre-intervention (baseline) and post-intervention measurements will be obtained before and immediately after the 14-day period.
- All meals will be provided throughout the supplementation period
- Participants will wear a continuous glucose monitor for 6 consecutive days during the supplementation period.
干预措施: Exogenous ketone monoester (Dietary Supplement)
Placebo
Participants will consume a flavor matched placebo drink and undergo the same procedures described in the Experimental Arm
干预措施: Exogenous ketone monoester (Dietary Supplement)
结局指标
主要结局
Glucose control
时间窗: 2 hours after a meal
Post-prandial glucose excursions will be measured by continuous glucose monitoring using the iPro2 CGM by Medtronic in both the active and placebo supplement conditions. Post-prandial glucose following breakfast, lunch, and dinner will be averaged together.
次要结局
- Change from baseline flow mediated dilation at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline histone acetylation at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline mitochondrial superoxide production at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline cognition (executive functions) at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline plasma glucose at 14 days(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 plasma free fatty acids at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline interleukin-1(IL)-1beta at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline caspase-1 activation at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
研究者
Jonathan Little
Assistant Professor
University of British Columbia