Cognitive Change
Conditions
Keywords
Alpha Hope, Pyrroloquinoline Quinone, Molecular Hydrogen
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTDrink
Consume one tablet fully dissolved in 8 ounces. Take 2 tablets per day for adults (morning and evening) for 4 weeks
Sponsors
Calerie LLC
University of Memphis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Tablets will be of similar appearance and provided in bottles labeled A and B
Intervention model description
Subjects take randomly assigned condition for 4 weeks, then washout for 3 weeks before crossing over to other condition for 4 weeks.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Digit Symbol Substitution test | baseline | 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) |
| AX-Continuous Performance Test | baseline | 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 |
| Go/No-Go test | baseline | Subjects press a key when Go is displayed and no key when No Go is displayed to test accuracy and reaction time. |
| irisin | baseline | Irisin is quantified from blood sample |
| brain-derived neurotrophic factor | baseline | Brain-derived neurotrophic factor is quantified from blood sample |
| Fibroblast growth factor 21 | baseline | Fibroblast growth factor 21 factor is quantified from blood sample |
| Self-reported Wellness Assessment | baseline | Subjects report their self-reported wellness using a visual analog scale from 0-10 with 0 being extremely low and 10 being extremely high |
| Blood Pressure | baseline | Blood pressure (diastolic and systolic) is measured using an automated machine |
| Heart Rate | baseline | Heart Rate is measured using an automated machine |
Countries
United States
Outcome results
None listed