Effect of SageXtra Supplementation on Cognitive Function in Middle-Aged Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- COMputerized Mental Performance ASsessment System (COMPASS) Test Battery
研究概览
简要总结
Sage (Salvia officinalis) has been reported to have antioxidant, anti-inflammatory, and neuroprotective properties. Several studies indicate that sage supplementation can improve cognitive function. However, more research is needed. The purpose of this study is to examine how sage supplementation affects cognitive function and reaction times in middle-aged men and women.
详细描述
To evaluate the effects of sage extract (sageXtra™) on cognitive function and psychomotor performance in middle-aged men and women, subjects (40-60 years) will receive 333 mg of SageXtra or placebo daily for 8 consecutive weeks.
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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18.5-34.9 (inclusive) with a goal of being < 30 on average
- •Subject agrees to maintain their existing dietary patterns throughout the study period.
- •Subject agrees to refrain from alcohol, caffeine, and strenuous exercise for 24 hours before each test day.
- •Subject is willing and able to comply with the study protocol.
- •Has given voluntary, written, informed consent to participate in the study.
排除标准
- •Individuals with a personal history of a psychiatric disorder.
- •Individuals who are determined to have liver, renal, cardiovascular, or other metabolic disease.
- •Current or recent (< 4 weeks) use of any dietary supplements (e.g., choline, lecithin, ginseng, ginkgo biloba, ashwagandha, Bacopa Monnieri, Paullina cupana, Rhodiola rosea, L-theanine, omega-3 fats, Prevagen, etc.), or currently prescribed medications (e.g., Adderall, Mydayis, Ritalin, Concerta, Mythylin, Provigil, Namenda), that may affect cognitive function (focus, concentration, memory, reaction time, energy, etc.).
- •Alcohol consumption (>2 standard alcoholic drinks/day or >10 drinks/week) or drug abuse/dependence (including regular marijuana or THC use).
- •Currently a smoker.
- •Allergy or sensitivity to study product ingredients.
- •Individuals who are cognitively impaired and/or who are unable to give informed consent.
- •Any other condition which, in the PI's opinion, may adversely affect the subject's ability to complete the study, its measurements, or pose a significant risk to the subject.
研究组 & 干预措施
Active
333 mg/day of SageXtra sage extract powder in two #0 capsules (167 mg/capsule).
干预措施: SageXtra (Dietary Supplement)
Placebo
333 mg/day of methylcellulose powder in two #0 capsules.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
COMputerized Mental Performance ASsessment System (COMPASS) Test Battery
时间窗: 4 weeks and 8 weeks
COMPASS consists of seven components including; 1) Immediate and Delayed Word Recall, 2) Delayed Word Recognition, 3) Delayed Picture Recognition, 4) Corsi Blocks Task, 5) Digit Vigilance, 6) Stroop Test and, 7) Choice Reaction Time evaluated via a computer program.
次要结局
- Physical performance(4 weeks and 8 weeks)