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临床试验/NCT05589051
NCT05589051已完成不适用

Effect of Alpha Hope Dietary Supplement on Biochemical Markers of Health and Computerized Tests of Cognitive Performance

University of Memphis2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Go/No-Go test

研究概览

简要总结

The purpose of the present research study is to evaluate the claims about the supplement influencing cognitive function that may impact performance on cognitive task and related biochemical measures. The synergistic administration of Pyrroloquinoline Quinone and molecular Hydrogen (in the form of Alpha Hope) will be evaluated in adults without a diagnosis of disease (i.e., otherwise healthy adults-the population the supplement is marketed to) on certain biochemical markers, subject's self-assessed wellness, and functional measurements determined via computer tests.

详细描述

Alpha Hope is a dietary supplement that contains Pyrroloquinoline Quinone and Magnesium-which has been shown to generate molecular hydrogen when mixed into water. Both Pyrroloquinoline Quinone and molecular hydrogen have been shown to exhibit antioxidant and anti-inflammatory capacities. Both Pyrroloquinoline Quinone and magnesium are widely used as dietary supplements, alone and in combination with other ingredients; however, to our knowledge, this is the first time that these two ingredients have been coupled together within one dietary supplement.

Previous research has demonstrated a wide range of health benefits from Pyrroloquinoline Quinone. Of particular interest, Pyrroloquinoline Quinone has been shown to improve cognition when supplemented at daily dosages similar to that proposed in the present study.

Molecular hydrogen has inherent anti-apoptosis, anti-inflammatory, and anti-oxidation properties and has therefore been studied in numerous animal studies, as well as human studies as a possible treatment for degenerative brain function. One method for generating molecular hydrogen, is using elemental magnesium, which reacts with water to generate molecular hydrogen.

The purpose of the present research study is to evaluate the claims about the supplement influencing cognitive function that may impact performance on cognitive task and related biochemical measures. The synergistic administration of Pyrroloquinoline Quinone and molecular Hydrogen (in the form of Alpha Hope) will be evaluated in adults without a diagnosis of disease -(i.e., otherwise healthy adults- the population the supplement is marketed to) on certain biochemical markers, subject's self-assessed wellness, and functional measurements determined via computer tests.

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)

盲法说明

Tablets will be of similar appearance and provided in bottles labeled A and B

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy (no diagnosed disease, including but not limited to metabolic, cardiovascular disease, or neurological disease)
  • Able to consume calcium carbonate (the placebo)
  • able to fast overnight (>10 hrs)

排除标准

  • tobacco user
  • currently taking a physician recommended medication/dietary supplement for cognition or brain health, including donepezil (Aricept®), rivastigmine tartrate (Exelon®), galantamine HBr (Reminyl®), and memantine (Namenda®), modafinil (Provigil®), Ginkgo biloba, ginseng B vitamins, Vitamin E, omega-3 fatty acids, Vitamins A & C, Vitamin D, phosphatidylserine, phosphatidylcholine, or supplements with brain, cogni, neuro, or similar in their names.
  • taking an over-the-counter medication or dietary supplement that can effect cognition/brain health, including Ginkgo biloba, ginseng B vitamins, Vitamin E, omega-3 fatty acids, Vitamins A & C, Vitamin D, phosphatidylserine, phosphatidylcholine, or supplements with brain, focus, memory, cogni, or neuro in their names.
  • diagnosed with any of these conditions (contraindicative for calcium carbonate): high calcium levels (hypercalcemia), stomach/intestinal blockage, kidney disease (such as kidney stones) (Cleveland Clinic)
  • taking any medication that interacts with calcium carbonate including ammonium chloride, methenamine, antibiotics like ciprofloxacin or tetracycline, captopril, delavirdine, gabapentin, iron supplements, medicines for fungal infections like ketoconazole and itraconazole, medicines for seizures like ethotoin and phenytoin, mycophenolate, quinidine, rosuvastatin, sucralfate, thyroid medicine (Cleveland Clinic)
  • consumption of alcohol-containing beverages within 24 hours of testing
  • consumption of caffeine within 24 hours of testing
  • strenuous exercise within 24 hours of testing
  • self-reported active infection or illness of any kind
  • pregnant or lactating
  • allergic or hypersensitive to any of the components of the supplement and placebo: PQQ, magnesium, malic acid, dextrose, adipic acid, citric acid, natural flavor, blackberry leaf extract, calcium carbonate

结局指标

主要结局

Go/No-Go test

时间窗: 4 week timepoint

Subjects press a key when Go is displayed and no key when No Go is displayed to test accuracy and reaction time.

Digit Symbol Substitution test

时间窗: 4 week timepoint

Using the response key (at the top of the test), subjects select the corresponding number with a computer mouse that corresponds with the specific symbol displayed on the computer screen to obtain as many correct responses as they can within a set time frame (two minutes)

Self-reported Wellness Assessment

时间窗: 4 week timepoint

Subjects report their self-reported wellness using a visual analog scale from 0-10 with 0 being extremely low and 10 being extremely high

AX-Continuous Performance Test

时间窗: 4 week timepoint

Subject press different keys on a keyboard to indicate if the stimulus is the target (AX) or non-target to measure accuracy and response time

brain-derived neurotrophic factor

时间窗: 4 week timepoint

Brain-derived neurotrophic factor is quantified from blood sample

irisin

时间窗: 4 week timepoint

Irisin is quantified from blood sample

Blood Pressure

时间窗: 4 week timepoint

Blood pressure (diastolic and systolic) is measured using an automated machine

Heart Rate

时间窗: 4 week timepoint

Heart Rate is measured using an automated machine

Fibroblast growth factor 21

时间窗: 4 week timepoint

Fibroblast growth factor 21 factor is quantified from blood sample

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Bloomer

Dean of the College of Health Sciences

University of Memphis

研究点 (2)

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