Characterizing the Pharmacokinetic Profile of a Novel Encapsulated Caffeine Beverage and Associated Mood and Physiological Effects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Plasma caffeine PK profile of (AUC0-t, AUC0-inf)
研究概览
简要总结
This study is designed to compare self-reported mood states for encapsulated caffeine compared to dose-matched free caffeine, when consumed as a ready-to-drink beverage in healthy subjects. Additionally, this study will characterize the plasma caffeine pharmacokinetic profile for the encapsulated and free caffeine beverages. Two different caffeine levels, 160 and 250 mg will be included, which represent more common caffeine consumption from typical energy drinks.
The primary outcomes are alertness ratings from the Caffeine Research visual analog scale (VAS) and PK parameters over 12 hours. Secondary outcomes are Caffeine Research VAS scores (beyond alertness), three other symptom VAS scores, and vital signs for safety.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male and female volunteers aged 18 to 55 years
- •Have a BMI of 18 to 32.49 kg/m2 (inclusive)
- •Are regular caffeine consumers (average 1 to 3 caffeine-containing beverages per day, not to exceed 400 mg/ per day)
- •Willing to commit to 4 long test days (~15-16 hrs)
- •Able to comprehend and willing to sign an Informed Consent Form (ICF)
- •Willing to avoid caffeine-containing products for ≥48 hrs prior to visits and until the completion of each test visit
- •Willing to avoid alcohol for ≥24 hrs prior to visits
- •Willing to fast 10 hrs prior to visits
- •Willing to stick to their usual dietary patterns and avoid grapefruit
- •Willing to stick to their usual physical activity level throughout the study
- •Willing to stick to their usual sleep pattern
- •No participation in any clinical trial within the past 30 days and throughout this study, or any PEP protocol within the past 6 months
排除标准
- •Subjects will be excluded from the study if they have:
- •Reported history or clinical manifestations of significant metabolic (including type1 or type 2 diabetes mellitus), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders unless deemed clinically not significant by investigator
- •Current or recent history (<30 days prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection
- •Current clinically significant viral infection
- •History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
- •Are pregnant or breastfeeding or planning to become pregnant
- •Resting heart rate less than 45 bpm or greater than 100 bpm
- •History of unstable ischemic heart disease or uncontrolled hypertension (blood pressure greater than or equal to 50/90 mm Hg)
- •History of significant surgery that may affect absorption of caffeine. Appendectomy and/or cholecystectomy will be allowed
- •Presence of a malabsorption syndrome possibly affecting drug/Product absorption (e.g., Crohn's disease or chronic pancreatitis)
- •Extreme dietary habits, including but not limited to intentional consumption of a high fiber diet, gluten-free, low-carb, vegan, ketogenic
- •History of alcoholism or drug addiction within 1 year prior to Screening, or current alcohol or drug use that, in the opinion of the investigator, will interfere with the subject's ability to comply with the dosing schedule and study evaluations
- •One or more tobacco-containing or nicotine-containing product occasions per month on average, or use of such products within 48 hours prior to dosing of each study period
- •Use of any prescription or nonprescription drugs (including vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations) is prohibited within 7 days prior to the dose of study product, unless deemed acceptable by the Investigator
- •Use of any medication known to have an interaction with caffeine including oral contraceptives (e.g., medications metabolized via the CYP1A2 pathway)
- •Donation of blood in excess of 500 ml within 4 weeks prior to study entry or of plasma within 2 weeks prior to Screening
- •Receipt of blood products within 3 months prior to study entry
- •Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
研究组 & 干预措施
Beverage 1
Free caffeine 160 mg
干预措施: Flavored caffeinated beverage (Other)
Beverage 2
Encapsulated caffeine 160 mg
干预措施: Flavored caffeinated beverage (Other)
Beverage 3
Free caffeine 250 mg
干预措施: Flavored caffeinated beverage (Other)
Beverage 4
Encapsulated caffeine 250 mg
干预措施: Flavored caffeinated beverage (Other)
结局指标
主要结局
Plasma caffeine PK profile of (AUC0-t, AUC0-inf)
时间窗: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine (AUC0-t, AUC0-inf)
Alertness
时间窗: Changes from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post beverage ingestion
A self-reported mood measurement from the Caffeine Research Visual Analog Scale (VAS) rated from 0 (not at all) to 100 mm (extremely alert), to compare dose-matched free caffeine to encapsulated caffeine. Longer-lasting alertness would be a benefit.
Plasma caffeine PK profile of peak caffeine concentration (Cmax)
时间窗: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine peak caffeine concentration (Cmax)
Plasma caffeine PK profile of time to maximal plasma caffeine concentration (Tmax)
时间窗: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine time to maximal plasma caffeine concentration (Tmax)
Plasma caffeine PK profile of half-life (t1/2)
时间窗: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine half-life (t1/2)
Plasma caffeine PK profile of plasma caffeine concentration by time
时间窗: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine concentration by time
次要结局
- The 6 other Caffeine Research Visual Analog Scale (VAS) symptom ratings besides alertness(Changes from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post beverage ingestion)
- 3 additional other symptoms Visual Analog Scale (VAS) ratings(Changes from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post beverage ingestion)
- Blood pressure(Changes from pre-dose baseline to 2 and 6 hours post beverage ingestion)
- Heart rate(Changes from pre-dose baseline to 2 and 6 hours post beverage ingestion)