Cognitive ChangeNCT05589051
Effect of Alpha Hope Dietary Supplement on Health and Cognitive Performance
A study testing Drink in people with Cognitive Change, run by University of Memphis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152
About this study
Official title: Effect of Alpha Hope Dietary Supplement on Biochemical Markers of Health and Computerized Tests of 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.
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.
- Conditions
- Cognitive Change
- Being tested
- Drink
- Keywords
- Alpha Hope, Pyrroloquinoline Quinone, Molecular Hydrogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrinkDietary supplement
Consume one tablet fully dissolved in 8 ounces. Take 2 tablets per day for adults (morning and evening) for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Drink |
| Placebo | Placebo comparator | Same formulation as experimental with 250 mg calcium carbonate replacing the magnesium and PQQ. Receives: Dietary Supplement: Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 4 week timepoint
irisin
Irisin is quantified from blood sample
Measured: baseline
irisin
Irisin is quantified from blood sample
Measured: 4 week timepoint
brain-derived neurotrophic factor
Brain-derived neurotrophic factor is quantified from blood sample
Measured: baseline
brain-derived neurotrophic factor
Brain-derived neurotrophic factor is quantified from blood sample
Measured: 4 week timepoint
Fibroblast growth factor 21
Fibroblast growth factor 21 factor is quantified from blood sample
Measured: baseline
Fibroblast growth factor 21
Fibroblast growth factor 21 factor is quantified from blood sample
Measured: 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
Measured: 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
Measured: 4 week timepoint
Blood Pressure
Blood pressure (diastolic and systolic) is measured using an automated machine
Measured: baseline
Blood Pressure
Blood pressure (diastolic and systolic) is measured using an automated machine
Measured: 4 week timepoint
Heart Rate
Heart Rate is measured using an automated machine
Measured: baseline
Heart Rate
Heart Rate is measured using an automated machine
Measured: 4 week timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start21 Mar 2022
- Primary completion28 Oct 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects take randomly assigned condition for 4 weeks, then washout for 3 weeks before crossing over to other condition for 4 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- Calerie LLC
- Responsible party
- Principal investigator, Richard Bloomer, University of Memphis
- Investigators
- Richard Bloomer, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589051
- Sponsor's protocol ID
- PRO-FY2022-130
- Status last verified
- Sep 2023
- First submitted
- 17 Oct 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alpha Hope Dietary Supplement on Biochemical Markers of Health and Computerized Tests of Cognitive Performance
- ClinicalTrials.gov ID
- NCT05589051
- Acronym / sponsor ID
- PRO-FY2022-130
- Conditions
- Cognitive Change
- Keywords
- Alpha Hope, Pyrroloquinoline Quinone, Molecular Hydrogen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- Calerie LLC
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects take randomly assigned condition for 4 weeks, then washout for 3 weeks before crossing over to other condition for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Alpha Hope | Experimental | Dietary Supplement: DrinkEach 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 |
| Placebo | Placebo comparator | Dietary Supplement: DrinkSame formulation as experimental with 250 mg calcium carbonate replacing the magnesium and PQQ. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DrinkConsume one tablet fully dissolved in 8 ounces. Take 2 tablets per day for adults (morning and evening) for 4 weeks | Dietary supplement | Alpha Hope, Placebo |
Primary outcome
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)
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)
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
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
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.
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.
irisin
Time frame: baseline
Irisin is quantified from blood sample
irisin
Time frame: 4 week timepoint
Irisin is quantified from blood sample
brain-derived neurotrophic factor
Time frame: baseline
Brain-derived neurotrophic factor is quantified from blood sample
brain-derived neurotrophic factor
Time frame: 4 week timepoint
Brain-derived neurotrophic factor is quantified from blood sample
Fibroblast growth factor 21
Time frame: baseline
Fibroblast growth factor 21 factor is quantified from blood sample
Fibroblast growth factor 21
Time frame: 4 week timepoint
Fibroblast growth factor 21 factor is quantified from blood sample
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
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
Blood Pressure
Time frame: baseline
Blood pressure (diastolic and systolic) is measured using an automated machine
Blood Pressure
Time frame: 4 week timepoint
Blood pressure (diastolic and systolic) is measured using an automated machine
Heart Rate
Time frame: baseline
Heart Rate is measured using an automated machine
Heart Rate
Time frame: 4 week timepoint
Heart Rate is measured using an automated machine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
Related trials for Cognitive Change
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
RecruitingPhase 1
A Study of LY3439539 in Participants With Alzheimer's Disease
Alzheimer Disease
Not yet recruiting
Magnetoencephalographic Correlates of Clinical Change After Cognitive Processing Therapy in Adults With PTSD
Trauma, Psychological, Traumatic Stress Disorder
Not yet recruiting
Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors
Brain Tumor, Pediatric
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bloomer, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drink in people with Cognitive Change, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digit Symbol Substitution test (time frame: baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.