Clinical trial NCT05589051: Effect of Alpha Hope Dietary Supplement on Health and Cognitive Performance
Official title: Effect of Alpha Hope Dietary Supplement on Biochemical Markers of Health and Computerized Tests of Cognitive Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Keywords: Alpha Hope
Pyrroloquinoline Quinone
Molecular Hydrogen
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: Calerie LLC
First posted: 2022-10-21
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Digit Symbol Substitution test
timeFrame: baseline
measure: Digit Symbol Substitution test
timeFrame: 4 week timepoint
measure: AX-Continuous Performance Test
timeFrame: baseline
measure: AX-Continuous Performance Test
timeFrame: 4 week timepoint
measure: Go/No-Go test
timeFrame: baseline
measure: Go/No-Go test
timeFrame: 4 week timepoint
measure: irisin
timeFrame: baseline
measure: irisin
timeFrame: 4 week timepoint
measure: brain-derived neurotrophic factor
timeFrame: baseline
measure: brain-derived neurotrophic factor
timeFrame: 4 week timepoint
measure: Fibroblast growth factor 21
timeFrame: baseline
measure: Fibroblast growth factor 21
timeFrame: 4 week timepoint
measure: Self-reported Wellness Assessment
timeFrame: baseline
measure: Self-reported Wellness Assessment
timeFrame: 4 week timepoint
measure: Blood Pressure
timeFrame: baseline
measure: Blood Pressure
timeFrame: 4 week timepoint
measure: Heart Rate
timeFrame: baseline
measure: Heart Rate
timeFrame: 4 week timepoint
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Center for Nutraceutical and Dietary Supplement Research
state: Tennessee
Study officials:
affiliation: University of Memphis
name: Richard Bloomer, PhD
role: PRINCIPAL_INVESTIGATOR
References: