Effect of Alpha Hope Dietary Supplement on Health and Cognitive Performance

Cognitive Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05589051
• Other study ID #: PRO-FY2022-130
• Status: Completed
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: November 10, 2022

Study information

• Verified date: September 2023
• Source: University of Memphis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 10, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change

Intervention

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

Locations

Country	Name	City	State
United States	Center for Nutraceutical and Dietary Supplement Research	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Memphis	Calerie LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	irisin	Irisin is quantified from blood sample	baseline
Primary	irisin	Irisin is quantified from blood sample	4 week timepoint
Primary	brain-derived neurotrophic factor	Brain-derived neurotrophic factor is quantified from blood sample	baseline
Primary	brain-derived neurotrophic factor	Brain-derived neurotrophic factor is quantified from blood sample	4 week timepoint
Primary	Fibroblast growth factor 21	Fibroblast growth factor 21 factor is quantified from blood sample	baseline
Primary	Fibroblast growth factor 21	Fibroblast growth factor 21 factor is quantified from blood sample	4 week timepoint
Primary	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
Primary	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
Primary	Blood Pressure	Blood pressure (diastolic and systolic) is measured using an automated machine	baseline
Primary	Blood Pressure	Blood pressure (diastolic and systolic) is measured using an automated machine	4 week timepoint
Primary	Heart Rate	Heart Rate is measured using an automated machine	baseline
Primary	Heart Rate	Heart Rate is measured using an automated machine	4 week timepoint