CClinicalTrials.gg
CompletedNCT05589051Updated Sep 26, 2023

Effect of Alpha Hope Dietary Supplement on Health and Cognitive Performance

An interventional study of Drink in Cognitive Change, sponsored by University of Memphis. Completed at 1 site in United States. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by University of Memphis · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Mar 2022, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cognitive Change

Keywords

  • Alpha Hope
  • Pyrroloquinoline Quinone
  • Molecular Hydrogen
03

In context

Lead sponsor

University of Memphis is the lead sponsor of 44 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Alpha Hope

    Each tablet contains 10 mg PQQ and 40 mg (19% DV) magnesium as well as malic acid, dextrose, adipic acid, citric acid, natural flavor, and blackberry leaf extract

    Dietary Supplement: Drink

  • Placebo comparator
    Placebo

    Same formulation as experimental with 250 mg calcium carbonate replacing the magnesium and PQQ.

    Dietary Supplement: Drink

Interventions

  • Dietary supplementDrink

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

06

What researchers measure

Primary outcomes

  1. Digit Symbol Substitution test

    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)

    Time frame: baseline

  2. Digit Symbol Substitution test

    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)

    Time frame: 4 week timepoint

  3. AX-Continuous Performance Test

    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

    Time frame: baseline

  4. AX-Continuous Performance Test

    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

    Time frame: 4 week timepoint

  5. Go/No-Go test

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

    Time frame: baseline

  6. Go/No-Go test

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

    Time frame: 4 week timepoint

  7. irisin

    Irisin is quantified from blood sample

    Time frame: baseline

  8. irisin

    Irisin is quantified from blood sample

    Time frame: 4 week timepoint

  9. brain-derived neurotrophic factor

    Brain-derived neurotrophic factor is quantified from blood sample

    Time frame: baseline

  10. brain-derived neurotrophic factor

    Brain-derived neurotrophic factor is quantified from blood sample

    Time frame: 4 week timepoint

  11. Fibroblast growth factor 21

    Fibroblast growth factor 21 factor is quantified from blood sample

    Time frame: baseline

  12. Fibroblast growth factor 21

    Fibroblast growth factor 21 factor is quantified from blood sample

    Time frame: 4 week timepoint

  13. Self-reported Wellness Assessment

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

    Time frame: baseline

  14. Self-reported Wellness Assessment

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

    Time frame: 4 week timepoint

  15. Blood Pressure

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

    Time frame: baseline

  16. Blood Pressure

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

    Time frame: 4 week timepoint

  17. Heart Rate

    Heart Rate is measured using an automated machine

    Time frame: baseline

  18. Heart Rate

    Heart Rate is measured using an automated machine

    Time frame: 4 week timepoint

07

Study locations

1 site
  • Center for Nutraceutical and Dietary Supplement Research
    Memphis, Tennessee 38152, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05589051
Lead sponsor
University of Memphis
Collaborators
Calerie LLC
Responsible party
Richard Bloomer (Dean of the College of Health Sciences, University of Memphis) — Principal investigator
First posted
Oct 21, 2022
Start date
Mar 21, 2022
Primary completion
Oct 28, 2022
Completion
Nov 10, 2022
Last update
Sep 26, 2023

Study contacts

Richard Bloomer, PhD
principal investigator · University of Memphis

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion