Skip to main content
OpenTrials
Completed

NCT Number: NCT05589051

Effect of Alpha Hope Dietary Supplement on Health and Cognitive Performance

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cognitive Change

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drink

Dietary Supplement

Consume one tablet fully dissolved in 8 ounces. Take 2 tablets per day for adults (morning and evening) for 4 weeks

Primary outcomes

  1. Digit Symbol Substitution test

    Time frame: 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)

  2. Digit Symbol Substitution test

    Time frame: 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)

  3. AX-Continuous Performance Test

    Time frame: 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

  4. AX-Continuous Performance Test

    Time frame: 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

  5. Go/No-Go test

    Time frame: baseline

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

  6. Go/No-Go test

    Time frame: 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.

  7. irisin

    Time frame: baseline

    Irisin is quantified from blood sample

  8. irisin

    Time frame: 4 week timepoint

    Irisin is quantified from blood sample

  9. brain-derived neurotrophic factor

    Time frame: baseline

    Brain-derived neurotrophic factor is quantified from blood sample

  10. brain-derived neurotrophic factor

    Time frame: 4 week timepoint

    Brain-derived neurotrophic factor is quantified from blood sample

  11. Fibroblast growth factor 21

    Time frame: baseline

    Fibroblast growth factor 21 factor is quantified from blood sample

  12. Fibroblast growth factor 21

    Time frame: 4 week timepoint

    Fibroblast growth factor 21 factor is quantified from blood sample

  13. Self-reported Wellness Assessment

    Time frame: 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

  14. Self-reported Wellness Assessment

    Time frame: 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

  15. Blood Pressure

    Time frame: baseline

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

  16. Blood Pressure

    Time frame: 4 week timepoint

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

  17. Heart Rate

    Time frame: baseline

    Heart Rate is measured using an automated machine

  18. Heart Rate

    Time frame: 4 week timepoint

    Heart Rate is measured using an automated machine

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • Calerie LLC

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2022
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.