Effect of Alpha Hope Dietary Supplement on Health and Cognitive Performance

NCT05589051 | Completed

• 1 other identifier: PRO-FY2022-130
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change

Keywords

Alpha Hope; Pyrroloquinoline Quinone; Molecular Hydrogen

Outcome Measures

Primary Outcomes (18)

• 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)

  baseline

• 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)

  4 week timepoint

• 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

  baseline

• 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

  4 week timepoint

• 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.

  baseline

• 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.

  4 week timepoint

• irisin

  Irisin is quantified from blood sample

  baseline

• irisin

  Irisin is quantified from blood sample

  4 week timepoint

• brain-derived neurotrophic factor

  Brain-derived neurotrophic factor is quantified from blood sample

  baseline

• brain-derived neurotrophic factor

  Brain-derived neurotrophic factor is quantified from blood sample

  4 week timepoint

• Fibroblast growth factor 21

  Fibroblast growth factor 21 factor is quantified from blood sample

  baseline

• Fibroblast growth factor 21

  Fibroblast growth factor 21 factor is quantified from blood sample

  4 week timepoint

• 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

  baseline

• 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

  4 week timepoint

• Blood Pressure

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

  baseline

• Blood Pressure

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

  4 week timepoint

• Heart Rate

  Heart Rate is measured using an automated machine

  baseline

• Heart Rate

  Heart Rate is measured using an automated machine

  4 week timepoint

Study Arms (2)

Alpha Hope

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Dietary Supplement: Drink

Interventions

Drink DIETARY_SUPPLEMENT

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

Alpha Hope; Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Memphis: lead
• Calerie LLC: collaborator

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location

Study Officials

• Richard Bloomer, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Tablets will be of similar appearance and provided in bottles labeled A and B
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the College of Health Sciences

Model Details: Subjects take randomly assigned condition for 4 weeks, then washout for 3 weeks before crossing over to other condition for 4 weeks.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 21, 2022
• Study Start: March 21, 2022
• Primary Completion: October 28, 2022
• Study Completion: November 10, 2022
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

US (1)