The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults: A Neurophysiological and Resting Functional Magnetic Resonance Study (rfMRI)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Grey Matter Volume
研究概览
简要总结
This project comprises an initial crossover placebo-controlled neurophysiological study to ascertain the effect of acute ketone ester ingestion on motor cortex plasticity, followed by a second 2-week intervention study aimed to compare the effect of a ketogenic diet versus ketone ester supplementation on motor cortex plasticity, resting brain function and structure, and metabolic and neuroendocrine responses.
详细描述
The study initially makes a bold attempt to explore whether the ketone supplementation would induce improvements in the overweight/ obese population's brain health via altering motor cortex plasticity, brain function and structure, and metabolic and neuroendocrine pathways. The study's aims include:
- assessing changes in brain plasticity associated with excessive body weight and/or obesity.
- evaluating the potential of ketone monoester supplementation in enhancing brain plasticity.
- evaluating the potential of ketone monoester supplementation in correcting impaired brain plasticity due to excessive body weight.
- evaluating the impact of short-term ketogenic dieting and ketone monoester supplementation on brain plasticity.
- investigating structural and functional brain adaptations to short-term ketogenic dieting and ketone supplementation.
- assessing the relationship between changes in brain plasticity and the brain's structural and functional adaptations and changes in circulating levels of brain-derived neurotrophic factors and key central acting hormones (i.e., insulin and leptin) due to ketogenic dieting and ketone monoester supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) > 25 and < 35 kg/m2 (overweight/obese group) or BMI > 18.5 and < 25 kg/m2 (healthy weight group);
- •Right-handed.
排除标准
- •Presenting any established counter indication for transcranial magnetic stimulation;
- •Currently taking any medication affecting the central or the peripheral nervous system;
- •Suffering from any psychiatric, neurologic, cardiovascular, or metabolic disease, including type 1 and type 2 diabetes mellitus;
- •Undertaking surgery in the past six months;
- •Engaged in resistance training.
- •Pregnancy;
- •Breastfeeding;
- •Being amenorrhea.
结局指标
主要结局
Grey Matter Volume
时间窗: 2 weeks
The measurement name is "grey matter volume", which belongs to brain structure. The grey matter volume will be assessed by the magnetic resonance imaging system. Grey matter volume is generally measured in cubic centimeters (cm³) or milliliters (mL), as both units are equivalent in volume measurement (1 cm³ = 1 mL). This measure reflects the volume of grey matter regions in the brain, which include areas dense with neuronal cell bodies, dendrites, axon terminals, and glial cells.
Brain Plasticity
时间窗: 2 weeks
This measurement is "brain plasticity". Brain plasticity, also known as neuroplasticity, refers to the brain's remarkable ability to change and adapt in response to experience. The brain plasticity will be measured by transcranial magnetic stimulation (TMS) system. When assessing brain plasticity using TMS through the measurement of Motor Evoked Potentials (MEPs), the primary unit of measurement is typically in millivolts (mV) for the amplitude of the MEPs. MEPs are electrical signals recorded from muscles after stimulation of the motor cortex with TMS, reflecting the excitability of the corticospinal pathway and, indirectly, cortical plasticity.
Cortical Thickness
时间窗: 2 weeks
The measurement name is "cortical thickness", which belongs to brain structure. The cortical thickness will be assessed by the magnetic resonance imaging system. Cortical thickness is measured in millimeters (mm). It refers to the average thickness of the grey matter cortex across various regions of the brain. Cortical thickness can vary significantly across different parts of the cortex, typically ranging from around 1 mm to 4 mm, depending on the specific brain region and individual differences.
Blood-Oxygen-Level-Dependent (BOLD) Signal Changes
时间窗: 2 weeks
The measurement name is "Blood-Oxygen-Level-Dependent (BOLD) Signal Changes", which belongs to brain function. The cortical thickness will be assessed by the magnetic resonance imaging system (MRI). The unit of BOLD signal changes measured by MRI is typically expressed as a percentage change (%). The BOLD signal reflects changes in the magnetic properties of blood due to variations in oxygenation levels that occur in response to neural activity.
次要结局
- Blood Insulin(6 weeks)
- Brain-Derived Neurotrophic Factor(6 weeks)
- Blood Glucose(6 weeks)
- Reaction Time of Stroop Task(2 weeks)
- Leptin(6 weeks)
- Blood Beta-Hydroxybutyrate(6 weeks)
- Accuracy of Attention Network Test(2 weeks)
- Height in Kilograms(2 weeks)
- Ghrelin(6 weeks)
- Reaction Time of N-back Task(2 weeks)
- Skinfold Thickness(2 weeks)
- Reaction Time of Attention Network Test(2 weeks)
- Accuracy of N-back Task(2 weeks)
- Cerebral Hemoglobin Concentration(2 weeks)
- Body Fat Percentage(2 weeks)
- Body Mass Index(2 weeks)
- Muscle Mass(2 weeks)
- Maximal Oxygen Uptake(2 weeks)
- Accuracy of Stroop Task(2 weeks)
- Weight in Meters(2 weeks)
- Fat Mass(2 weeks)
- Body Water(2 weeks)