An Evaluation of the Effects of a Non-Caffeinated Energy Die-tary Supplement on Cognitive and Physical Performance: A Randomized Double-Blind Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Mood
研究概览
简要总结
This study tested the effects of a botanical blend to a caffeine and a placebo condition on 1) self-reported alertness, anxiety, and headaches 2) multiple measures of attention 3) physical performance and 4) stress biomarkers.
详细描述
This study aimed to build on this work by investigating the possibility that a specific botanical blend (Phytovive™); comprised of Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins) could improve cognitive and physical performance. To this end, this study was a randomized, double-blind, placebo-controlled 21-day parallel study on 36 healthy adults. The study compared the effects of the botanical blend at baseline to a caffeine and a placebo condition on 1) self-reported alertness, anxiety, and headaches 2) multiple measures of attention 3) physical performance and 4) stress biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blind
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
- •Adult males and females from 18 to 50 years (inclusive) of age who are physically active and have been engaging in athletic and sporting endeavors consistently over a period of 6 months at minimum
- •BMI 18.0 (normal) to 34.9 (obese, class I) kg/ m2 inclusive
- •Agrees to maintain a stable lifestyle with no change in exercise or diet for the duration of the study
- •Current consumer of caffeine either through caffeinated beverages or foods
- •Non-smoker
- •Able to physically exercise, to run on a treadmill at moderate to high intensity for a brief time (typically less than 20 min)
- •Participants with normal blood pressure or participants with hypertension that is controlled (BP < 160/90 and who are on medication at a stable dose (same dose for ≥90 days)
- •Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, carry out all study-related procedures, communicate effectively with the study staff.
- •Females must be using an acceptable method of contraception such as: abstinence, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream), intrauterine device or hormonal contraception (oral, injectable, implantable, transdermal, or vaginal) used consecutively for at least 3 months prior to screening visit, vasectomized partner or use of implants for at least 6 months prior to screening visit; bilateral tubal ligation, hysterectomy, bilateral oophorectomy, or be postmenopausal status with amenorrhea (no menses) for at least 1 year prior to the screening visit.
排除标准
- •Have a known sensitivity or allergy to any of the study products or their ingredients
- •Have any medical condition or disease based on the professional judgement and experience of the principal investigator (PI) plus research industry standards that might affect or impact the administration of study products
- •Lactating, pregnant or planning to become pregnant during the study
- •History of drug or alcohol abuse in the 12 months prior to screening
- •History of psychiatric illness requiring hospitalization in the 6 months prior to screening
- •History of diabetes (Type I or II) or uncontrolled hypertension (either systolic BP >160 or diastolic BP >90)
- •Participation in or use of a research IP within 30 days prior to screening (cannot have been in another study within 30 days of screening)
结局指标
主要结局
Mood
时间窗: 21 Days
Self-reported Mood using the Mood and Physical Sensation Scale (higher scores reflect better mood)
Cognition
时间窗: 21 days
Cognitive performance on the NIH Toolbox Cognition Battery and Joggle Psychomotor Vigilance Task. T scores (higher is better) will be reported.
Physical Performance
时间窗: 21 Days
Time to Exhaustion (TTE) Test - running on a treadmill with an increased incline every minute until perceived exhaustion is reached
次要结局
未报告次要终点
研究者
Jaime Tartar
Professor
Nova Southeastern University