Effects of Oral Nicotine and Caffeine Pouches on Anaerobic Performance, Autonomic Function, Cognition, and Behavior
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Stroop Test - Digital Cognitive Function Test
研究概览
简要总结
The goal of this randomized placebo controlled crossover trial is to determine effects of oral nicotine and caffeine pouches on anaerobic performance, autonomic function, cognition, and behavior in adult non-obese adult male volunteers between ages 21 and 40.
Accordingly, the primary aims of the study are to determine the effects of acute oral nicotine pouches, oral caffeine pouches, or both, on measures of
- anaerobic performance
- cognition
- cardiovascular and autonomic function
- appetite and food intake.
Researchers will compare oral nicotine pouches, oral caffeine pouches, both oral nicotine and caffeine pouches, and a flavor and color matched placebo to see if how they differentially affect measurements of
- physical performance,
- cognition,
- cardiovascular and autonomic function
- appetite and food intake.
On four separate occasions, participants will be asked to place the oral pouches in their mouth and complete several anerobic cycling, cognitive, and balance tests while blood and salivary biomarkers, subjective appetite ratings, and cardiovascular and autonomic function measurements are collected. After each trial, participants will complete a 24-hr food record.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Being 21 to 40 years of age
- •Being biologically male
- •Having a body mass index (BMI) of < 30 kilograms/meter-squared
- •Participating in moderate/vigorous exercise for at least 150 minutes/week over the last month
排除标准
- •individuals who are younger than 21 or older than 40
- •missing any limbs or part of a limb
- •having any neuromuscular/musculoskeletal injury or impairment that would prevent performing any exercise/functional measures for this study
- •having a pacemaker or any other electrical implant
- •a diagnosis (defined as the presence of disease of or using medication to treat the disease) of heart failure, cardiomyopathy (dilated or hypertrophic), valvular disease, type I or type II diabetes
- •taking insulin injections
- •any history of severe or mild traumatic brain injury within the last two years
- •kidney, liver, thyroid, or heart disease
- •treated or untreated American Heart Association stage 2 hypertension (>140 millimeters of mercury / > 90 millimeters of mercury)
- •any diagnosed neurological or neurodegenerative diseases
- •having donated blood or plasma in the last 20 days prior to blood collection procedures
- •taking any supplements/medications that may interfere with the results of the study
- •any surgeries that would impact swallowing and/or digestion
- •currently smoking, vaping, using e-cigarettes, or using any other combustible/smokeless tobacco products
- •using smokeless tobacco-free nicotine products on more than 2 days/week
- •daily caffeine use of more than 250 milligrams/day or use of any oral caffeine pouches
- •have allergies or are regularly taking medications that would impact this study and/or negatively interact with caffeine or nicotine.
结局指标
主要结局
Stroop Test - Digital Cognitive Function Test
时间窗: Baseline, 15, 32 minutes post-ingestion
Changes in Stroop test scores
Concentration of blood lactate
时间窗: Baseline, 25, 32 minutes post-ingestion
Changes in blood lactate concentration from capillary blood
Concentration of salivary interleukin-6
时间窗: Baseline, 15, 25, 32 minutes post-ingestion
Changes in interleukin-6 concentration from saliva
Salivary catecholamine concentration
时间窗: Baseline, 15, 27, 40 minutes post-ingestion
Changes in salivary catecholamine concentration from saliva
Ratings of perceived exertion
时间窗: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion
Changes in ratings of perceived exertion (Scale range: 6-20 - lower ratings means less effort))
Heart Rate
时间窗: Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion
Absolute heart rate values and relative changes from baseline.
Cerebral Blood flow
时间窗: Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion
Doppler ultrasound derived blood flow in the carotid artery
Concentration of salivary cortisol
时间窗: Baseline, 15, 25, 32 minutes post-ingestion
Changes in salivary cortisol concentration from saliva
Desire to eat - Visual Digital Analog Scale (0-100)
时间窗: Baseline, 15, 25, 32, 60 minutes post-ingestion
Changes in subjective ratings of desire to eat
Hunger - Visual Digital Analog Scale (0-100)
时间窗: Baseline, 15, 25, 32 minutes post-ingestion
Changes in subjective ratings of hunger
Trail Making Test - Digital Cognitive Function Test
时间窗: Baseline, 15, 32 minutes post-ingestion
Changes in trail making test scores
Sustained Attention Test - Digital Cognitive Function Test
时间窗: Baseline, 15, 32 minutes post-ingestion
Changes in sustained attention test scores
Visual Working Memory Span Test - Digital Cognitive Function Test
时间窗: Baseline, 15, 32 minutes post-ingestion
Changes in visual working memory span test scores
Wingate Anaerobic Cycling Test
时间窗: Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, 32, and 60 minutes post-ingestion
Changes in anaerobic cycling power output
Profile of Mood States
时间窗: Baseline, 15, 32 minutes post-ingestion
Changes in Profile of Mood States scores (Score range: 0-60)
Balance
时间窗: Baseline, 15, 32 minutes post-ingestion
Changes in standing postural sway
Prospective Consumption of Food - Visual Digital Analog Scale (0-100)
时间窗: Baseline, 15, 25, 32, 60 minutes post-ingestion
Changes in subjective ratings of prospective consumption of food
Fullness - Visual Digital Analog Scale (0-100)
时间窗: Baseline, 15, 25, 32, 60 minutes post-ingestion
Changes in subjective ratings of fullness
Food Intake - Digital 24-hour food record
时间窗: 24 hours following the end of each visit
Consumption of food and beverage after study visit
Blood Pressure
时间窗: Baseline, 15, 19, 23, 27, 31, and 60 minutes post-ingestion
Absolute brachial blood pressure values (systolic and diastolic) and relative changes from baseline.
Deary-Liewald Test - Digital Cognitive Function Test
时间窗: Baseline, 15, 32 minutes post-ingestion
Changes in Deary-Liewald test scores
次要结局
- Prefrontal Cortex Oxygenation(Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion)
- Blood Glucose Concentration(Baseline, 15, 25, 32 minutes post-ingestion)
- Salivary insulin concentration(Baseline, 15, 25, and 32 minutes post-ingestion)
- Peripheral Vascular Conductance(Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion)
- Peripheral Blood Flow(Baseline, 15, 19, 23, 27, and 31 minutes post-ingestion)
- Electromyography(Baseline, 15, 16, 19, 20, 23, 24, 27, 28, 31, and 32 minutes post-ingestion)
研究者
Austin Graybeal
Assistant Professor
University of Southern Mississippi