Effects of Dietary Supplement Intervention on Cognitive Function and Psychological Well-Being
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Digit Span Forward
研究概览
简要总结
This study's purpose is to evaluate the effects of a dietary supplement on cognitive function and psychological well-being in community-dwelling older adults aged 55+. The study involves taking a commercially available dietary supplement daily for 45 days. A 45-minute assessment will be conducted at the beginning and again at the end of the study.
详细描述
The primary aim of this randomized, single-site pilot study is to evaluate the effects of the oral liquid dietary supplement Axolt (https://axoltbrain.com) on cognitive function in adults aged 55 and older without cognitive impairment, compared to a control group taking a commercially available, hydration powdered drink flavoring, Bolero (https://bolerousa.net) daily for 45 days. The secondary aim is to assess changes in mood and psychological well-being with supplement intake. The study will use validated, low-risk cognitive measures at baseline and at the end of the study to measure change over time. 20 individuals age 55 years and older will be recruited. Sample size for enrollment: (n =8) for the active group and (n=8) in the control group (16 total), accounting for an anticipated 20% drop out rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 55 years and older
- •Live independently,
- •Self-report as healthy
- •Adequate vision
- •Fluent in English
- •No history of mild cognitive impairment
- •Currently not taking dietary supplements with the same active ingredients in Axolt or naturally flavored water
- •A Montreal Cognitive Assessment [12] (MOCA) score ≥ 24
- •Able to provide written informed consent, and medical clearance to participate.
排除标准
- •Previous participation in a cognitive dietary supplement study in the last 12 months
- •A score of < 24 on the Montreal Cognitive Assessment (MoCA) as a potential risk for obtaining informed consent
- •History of seizures
- •Parkinson's disease
- •History of severe head trauma
- •Uncontrolled hypertension
- •On psychoactive medications
- •Substance abuse
- •Unwilling or unable to discontinue current dietary supplements with similar ingredients
- •Planned surgery during the study period
- •Medications known to interact with active ingredients with Axolt
- •Minors and prisoners will be excluded.
研究组 & 干预措施
Axolt Brain Supplement
The active intervention group will be asked to consume 1 packet of Axolt dissolved in about 16 oz of water once a day for 45 days.
干预措施: Axolt Brain Supplement (Dietary Supplement)
Bolero - Flavored Drink Placebo
The control group will be asked to consume 1 packet of Bolero flavored water mix hydration enhancement also in about 16 oz of water once a day for 45 days.
干预措施: Bolero - Flavored Drink Placebo (Dietary Supplement)
结局指标
主要结局
Digit Span Forward
时间窗: From enrollment to the end of treatment at 45 days.
Digit Span Forward measures short-term memory (5 min.) Score: Min = 2, Max = 8 \*Higher score means better outcome
RAVLT Recall
时间窗: From enrollment to the end of treatment at 45 days.
Rey Auditory Verbal Learning Test (RAVLT) Recall measures long-term memory (5 min.). Score: Min = 0, Max = 15 \*Higher score means better outcome
Brain Fog Questionnaire
时间窗: From enrollment to the end of treatment at 45 days.
Brain Fog Questionnaire allows entry of self-reported cognitive difficulties (5 min.). Score: Min = 0, Max = 10 \*Lower score means better outcome
PHQ-9
时间窗: From enrollment to the end of treatment at 45 days.
The Patient Health Questionnaire (PHQ-9) records depressive symptoms (5 min.). Score: Min = 0, Max = 27 \*Lower score means better outcome
GAD-7
时间窗: From enrollment to the end of treatment at 45 days.
Generalized Anxiety Disorder 7-item Questionnaire (GAD-7) quantifies anxiety (5 min.). Score: Min = 0, Max = 21 \*Lower score means better outcome
Digit Span Forward
时间窗: From enrollment to the end of treatment at 45 days.
Digit Span Forward measures short-term memory (5 min.) Score: Min = 2, Max = 8 \*Higher score means better outcome
RAVLT Learning
时间窗: From enrollment to the end of treatment at 45 days.
Rey Auditory Verbal Learning Test (RAVLT) Learning assesses short-term memory (10 min). Score: Min = 0, Max = 105 \*Higher score means better outcome
RAVLT Recall
时间窗: From enrollment to the end of treatment at 45 days.
Rey Auditory Verbal Learning Test (RAVLT) Recall measures long-term memory (5 min.). Score: Min = 0, Max = 15 \*Higher score means better outcome
Brain Fog Questionnaire
时间窗: From enrollment to the end of treatment at 45 days.
Brain Fog Questionnaire allows entry of self-reported cognitive difficulties (5 min.). Score: Min = 0, Max = 10 \*Lower score means better outcome
PHQ-9
时间窗: From enrollment to the end of treatment at 45 days.
The Patient Health Questionnaire (PHQ-9) records depressive symptoms (5 min.). Score: Min = 0, Max = 27 \*Lower score means better outcome
GAD-7
时间窗: From enrollment to the end of treatment at 45 days.
Generalized Anxiety Disorder 7-item Questionnaire (GAD-7) quantifies anxiety (5 min.). Score: Min = 0, Max = 21 \*Lower score means better outcome
Digit Span Backward
时间窗: From enrollment to the end of treatment at 45 days.
Digit Span Backward measures working memory (5 min.). Score: Min = 2, Max = 8 \*Higher score means better outcome
Symbol Digit Modalities Test (SDMT)
时间窗: From enrollment to the end of treatment at 45 days.
Symbol Digit Modalities Test (SDMT) measures perceptual speed (5 min.). Score: Min = 0, Max = 120 \*Higher score means better outcome
次要结局
未报告次要终点
研究者
Judith Klein-Seetharaman
Professor
Arizona State University