Non-pharmacological Treatments for Obesity: Leveraging the Appetite Suppressive Effects of Hyperketonemia Through Exogenous Ketone Ingestion to Treat Obesity, Insulin Resistance, and Cognition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Blood pressure
研究概览
简要总结
The goal of this single-blind randomized placebo-controlled trial is to test the effects of an oral ketone supplement on appetite, cognition, metabolism, and cardiovascular function in individuals with obesity and insulin resistance.
The main question[s] it aims to answer are:
- Does taking the ketone supplement reduce appetite and improve cognition?
- How does the ketone supplement alter metabolism and cardiovascular function?
Participants will be asked to consume a randomly assigned ketone ester supplement or a placebo and testing will be done to see how the supplement affects the following compared to a placebo:
- appetite,
- cognition,
- metabolism
- cardiovascular function
Researchers will compare individuals with obesity and insulin resistance to individuals with normal weight and no insulin resistance to see if the ketone supplement affects groups differently.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between the ages of 18-50 years of age.
- •Presence of metabolic sydnrome
- •Control Participant Eligibility:
- •A waist circumference of < 102 cm for males and < 88 cm for females, and
- •No indication of metabolic syndrome
排除标准
- •Breastfeeding or lactating
- •Missing any limbs or part of a limb
- •Having a substantial amount of metal implants (metal plates or complete joint replacements)
- •Having a pacemaker or any other electrical implant
- •Type I diabetes
- •Gestational diabetes
- •Taking insulin
- •Any history of severe traumatic brain injury or mild traumatic brain injury within the last two years
- •Kidney disease
- •Liver disease
- •Thyroid disease
- •Any diagnosed neurological or neurodegenerative diseases
- •Any surgeries that would impact swallowing and/or digestion
- •Being on a ketogenic diet or having been on a ketogenic diet in the last 6 months
- •Having received ionizing radiation from a medical procedure within the last 30 days
- •Being on a medically prescribed diet
结局指标
主要结局
Blood pressure
时间窗: 105 minutes post ingestion
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Heart Rate
时间窗: 105 minutes post ingestion
Heart rate responses to sympathoexcitation
Number Back Test - Digital Cognitive Function Test
时间窗: Baseline, 75 minutes
Changes in Number Back Test score
Digit Span Test - Digital Cognitive Function Test
时间窗: Baseline, 75 minutes
Changes in Digit Span Test score
Stroop Test - Digital Cognitive Function Test
时间窗: Baseline, 75 minutes
Changes in Stroop score
Task Switching Task - Digital Cognitive Function Test
时间窗: Baseline, 75 minutes
Changes in Task Switching Task score
Prospective consumption of food - Visual Digital Analog Scale (0-100)
时间窗: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Changes in subjective rating of prospective consumption of food
Hunger - Visual Digital Analog Scale (0-100)
时间窗: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Changes in subjective rating of hunger
Heart Rate Variability
时间窗: 45 post ingestion
Index of cardiac autonomic control
Desire to eat - Visual Digital Analog Scale (0-100)
时间窗: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Changes in subjective rating of desire to eat
Thirst - Visual Digital Analog Scale (0-100)
时间窗: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Changes in subjective rating of thirst
Cardiac Baroreflex Sensitivity
时间窗: 105 minutes post ingestion
Changes in cardiac interval relative to changes in systolic blood pressure
Fullness - Visual Digital Analog Scale (0-100)
时间窗: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Changes in subjective rating of fullness
Go/No-go Test - Digital Cognitive Function Test
时间窗: Baseline, 75 minutes
Changes in Go/No-go score
次要结局
- Peripheral Vascular Conductance(Baseline, 30, 60 and 90 minutes post ingestion)
- Blood glucose(Baseline, 30, 60, 90, 120 minutes post ingestion)
- Prefrontal Cortex Oxygenation(Baseline, 90 minutes post ingestion)
- Peripheral Blood Flow(Baseline, 30, 60 and 90 minutes post ingestion)
- Oxygen Consumption from Respiratory Gases(Baseline and continuous for 120 minutes)
- Blood ketones(Baseline, 30, 60, 90, 120 minutes post ingestion)
- Carbon Dioxide Produced from Respiratory Gases(Baseline and continuous for 120 minutes)
研究者
Austin Graybeal
Assistant Professor
University of Southern Mississippi