The Effect of Acute Exogenous Oral Ketone Supplementation on Blood Glucose Levels in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Plasma Glucose
研究概览
简要总结
Exogenous ketone supplements are proposed to have glucose-lowering potential, provide an alternative fuel for the brain and to enhance cognitive function. No studies have tested whether exogenous ketones can lower blood glucose in people with type 2 diabetes. In addition, the impact of exogenous ketones on brain blood flow, cognitive function or brain-derived neurotrophic factor in humans is unknown. The purpose of this study is to determine if acutely ingesting exogenous ketones, in the form of a ketone monoester drink, can lower glucose and improve measures of brain/cognitive function in humans with type 2 diabetes. Participants will consume a ketone monoester drink or placebo with blood samples, brain blood flow, and cognitive function assessed over 180 minutes. The researchers will also test how the ketone monoester drink impacts appetite and measures of inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Placebo masked with flavouring and participants consume in opaque containers.
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physician-diagnosed type 2 diabetes of ≥1 year
- •current hemoglobin A1C (HbA1c) of 6.5-8.0%
- •treatment with lifestyle or stable (≥3 months) oral glucose-lowering medications
- •blood pressure of <160/99 mm Hg assessed according to guidelines
- •non-smoking
- •no prior history of cardiovascular disease or stroke
- •not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications
- •20-75 years old
排除标准
- •being a competitive endurance athlete
- •taking exogenous insulin or sodium glucose transporter 2 (SGLT2) inhibitors
- •following a ketogenic diet, low-calorie diet, periodic fasting regimen, or consume ketogenic supplements
- •being unable to travel to and from the university
- •being unable to follow the controlled diet instructions
- •being pregnant or planning to become pregnant during the study (if female)
- •disorders of fat metabolism, chronic pancreatitis, had gastric bypass surgery and/or gallbladder disease
- •being unable to read or communicate in English
结局指标
主要结局
Plasma Glucose
时间窗: 180 minutes
Plasma glucose concentration after ketone or placebo ingestion
次要结局
- Number Blood Monocytes (x10^3 Cells/uL)(180 minutes)
- Self Reported Hunger and Fullness(180 minutes)
- Plasma Insulin(180 minutes)
- Plasma C-peptide(180 minutes)
- Plasma Free Fatty Acids(180 minutes)
- Plasma Tumour Necrosis Factor Alpha(180 minutes)
- Plasma Tumour Interleukin-1beta(180 minutes)
- Plasma Tumour Interleukin-6(180 minutes)
- Cerebral Blood Flow(180 minutes)
- Blood Pressure(180 minutes)
- Cognitive Function - Digital Symbol Substitution Task(180 minutes)
- Brain-derived Neurotrophic Factor(180 minutes)
- Total Energy Consumed(180 minutes after ketone or placebo ingestion)
- Monocyte Histone Acetylation(180 minutes)
- Gastrointestinal Symptoms(180 minutes)
研究者
Jonathan Little
Assistant Professor
University of British Columbia