Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Calerie LLC | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Same formulation as experimental with 250 mg calcium carbonate replacing the magnesium and PQQ. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drink | Dietary Supplement | Consume one tablet fully dissolved in 8 ounces. Take 2 tablets per day for adults (morning and evening) for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Bloomer, PhD | University of Memphis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Nutraceutical and Dietary Supplement Research | Memphis | Tennessee | 38152 | United States |
Not provided
Subjects take randomly assigned condition for 4 weeks, then washout for 3 weeks before crossing over to other condition for 4 weeks.
Not provided
Not provided
Tablets will be of similar appearance and provided in bottles labeled A and B
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 |