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| Name | Class |
|---|---|
| Mibelle AG | INDUSTRY |
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Zanthozylum armatum (Z. armatum)-otherwise known as Nepalese pepper, or timut-is an perennial shrub found in India and across Southeast Asia. Preparations of the bark, fruit and seeds of Z. armatum have been extensively used in traditional Indian medicine. Preliminary data have indicated that preparations of Z. armatum may also be beneficial to cognitive function. The study aims to investigate the effects acute and chronic consumption of Z. armatum on cognitive function and cerebral blood flow.
Zanthozylum armatum (Z. armatum) is an perennial shrub found in India and across Southeast Asia. Preparations of the bark, fruit and seeds of Z. armatum have been extensively used in traditional Indian medicine. For example, the fruits and seeds have been employed as an aromatic tonic in fever and dyspepsia and the essential oil of the fruits has exhibited antibacterial, antifungal and anthelmintic properties. Furthermore, the dried fruits are used as spice, especially in Nepalese and Sichuan cuisine with increasing popularity across Europe. With regard to physiological effects relevant to brain function, Z. armatum has also been traditionally used as a cardio-depressant; these vasodilatory properties have recently being linked to its antagonistic effect on calcium ion channel function as demonstrated in isolated rabbit aorta tissue. In addition, the observed anti-inflammatory and antioxidant effects of preparations of Z. armatum may serve to beneficially impact cognition with chronic administration.
Although direct effects of Z. armatum on brain function have yet to be assessed; Zanthozylum fruit comprises one constituent of the traditional Japanese herbal medicine Daikenchuto (DKT) where some data do exist. In a series of trials investigating the effects of DKT on learning and memory function in mice, it was established that the extract of Zanthozylum fruit contained in DKT alone that was associated with reductions in escape latency in the Morris Water Maze task. Interestingly, the authors also revealed that it was the amide hydroxy-É‘-sanshool (HAS) isolated from the Zanthozylum fruit extract that was associated with these effects, speculating that the effect of HAS on escape latencies was due to a facilitation effect of HAS on acetylcholine release.
Given the evidence of potentially relevant mechanisms of action and initial evidence of cognitive effects of HAS in murine models, the aim of this study is to assess the acute and chronic effects of Z. armatum on cognitive function, mood, and cerebral blood flow in healthy adults aged 30 to 55 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zanthozylum armatum | Active Comparator | fruit extract |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanthozylum armatum | Dietary Supplement | Zanthozylum armatum MCT oil extract |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary memory score | This is a composite measure derived from summing the z score performance on the following cognitive tasks: immediate word recall, delayed word recall, delayed picture recognition, delayed word recognition, delayed name to face recall (-1 to 1 where higher is better). | Chronic (57 days) |
| Measure | Description | Time Frame |
|---|---|---|
| STAI-trait total score | State-trait anxiety inventory 'trait' score (20-80; higher is more anxious) | Baseline |
| STAI-state total score | State-trait anxiety inventory 'state' score (20-80; higher is more anxious) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippa A Jackson, PhD | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northumbria university | Newcastle upon Tyne | Tyne and Wear | NE1 8ST | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20041426 | Background | Gilani SN, Khan AU, Gilani AH. Pharmacological basis for the medicinal use of Zanthoxylum armatum in gut, airways and cardiovascular disorders. Phytother Res. 2010 Apr;24(4):553-8. doi: 10.1002/ptr.2979. | |
| 10075770 | Background | Kalia NK, Singh B, Sood RP. A new amide from zanthoxylum armatum. J Nat Prod. 1999 Feb;62(2):311-2. doi: 10.1021/np980224j. |
| Label | URL |
|---|---|
| Link to study site website | View source |
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| Placebo |
| Dietary Supplement |
sunflower oil matched for appearance |
|
| Chronic (57 days) |
| Secondary memory score | This is a composite measure derived from summing the z score performance on the following cognitive tasks: immediate word recall, delayed word recall, delayed picture recognition, delayed word recognition, delayed name to face recall (-1 to 1 where higher is better). | Acute (45, 180, 300 minutes post-dose) |
| Secondary memory score | This is a composite measure derived from summing the z score performance on the following cognitive tasks: immediate word recall, delayed word recall, delayed picture recognition, delayed word recognition, delayed name to face recall (-1 to 1 where 1 is better). | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Working memory score | This is a composite measure derived from summing the z score performance on the numeric working memory task and Corsi block-tapping task (-1 to 1; where higher is better) | Chronic (57 days) |
| Working memory score | This is a composite measure derived from summing the z score performance on the numeric working memory task and Corsi block-tapping task (-1 to 1; where higher is better) | Acute (45, 180, 300 minutes post-dose) |
| Working memory score | This is a composite measure derived from summing the z score performance on the numeric working memory task and Corsi block-tapping task (-1 to 1; where higher is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Speed of memory score | This is a composite measure derived from summing the z score reaction times on the numeric working memory task, the delayed name/face recall task, the delayed picture recognition task, and the delayed word recognition task (-1 to 1; where lower is better). | Acute (45, 180, 300 minutes post-dose) |
| Speed of memory score | This is a composite measure derived from summing the z score reaction times on the numeric working memory task, the delayed name/face recall task, the delayed picture recognition task, and the delayed word recognition task (-1 to 1; where lower is better) | Chronic (57 days) |
| Speed of memory score | This is a composite measure derived from summing the z score reaction times on the numeric working memory task, the delayed name/face recall task, the delayed picture recognition task, and the delayed word recognition task (-1 to 1; where lower is better). | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Accuracy of attention score | This is a composite measure derived from summing the z score accuracy performance on the choice reaction time and Rapid visual information processing tasks (-1 to 1; where higher is better) | Acute (45, 180, 300 minutes post-dose) |
| Accuracy of attention score | This is a composite measure derived from summing the z score accuracy performance on the choice reaction time and Rapid visual information processing tasks (-1 to 1; where higher is better) | Chronic (57 days) |
| Accuracy of attention score | This is a composite measure derived from summing the z score accuracy performance on the choice reaction time and Rapid visual information processing tasks (-1 to 1; where higher is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Speed of attention score | This is a composite measure derived from summing the z score reaction times on the choice reaction time and Rapid visual information processing tasks (-1 to 1; where lower is better) | Acute (45, 180, 300 minutes post-dose) |
| Speed of attention score | This is a composite measure derived from summing the z score reaction times on the choice reaction time and Rapid visual information processing tasks (-1 to 1; where lower is better) | Chronic (57 days) |
| Speed of attention score | This is a composite measure derived from summing the z score reaction times on the choice reaction time and Rapid visual information processing tasks (-1 to 1; where lower is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Immediate word recall task correctly identified words | total number (0-15; where higher is better) | Acute (45, 180, 300 minutes post-dose) |
| Immediate word recall task correctly identified words | total number (0-15; where higher is better) | Chronic (57 days) |
| Immediate word recall task correctly identified words | total number (0-15; where higher is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Immediate word recall task error responses | total number (can be any number; lower is better) | Acute (45, 180, 300 minutes post-dose) |
| Immediate word recall task error responses | total number (can be any number; lower is better) | Chronic (57 days) |
| Immediate word recall task error responses | total number (can be any number; lower is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Delayed word recall task correctly identified words | total number (0-15; where higher is better) | Acute (45, 180, 300 minutes post-dose) |
| Delayed word recall task correctly identified words | total number (0-15; where higher is better) | Chronic (57 days) |
| Delayed word recall task correctly identified words | total number (0-15; where higher is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Delayed word recall task correctly error responses | total number (can be any number; lower is better) | Acute (45, 180, 300 minutes post-dose) |
| Delayed word recall task correctly error responses | total number (can be any number; lower is better) | Chronic (57 days) |
| Delayed word recall task correctly error responses | total number (can be any number; lower is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Picture recognition accuracy | (%; 0-100; where higher is better) | Acute (45, 180, 300 minutes post-dose) |
| Picture recognition accuracy | (%; 0-100; where higher is better) | Chronic (57 days) |
| Picture recognition accuracy | (%; 0-100; where higher is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Picture recognition reaction time | (ms; lower is better) | Acute (45, 180, 300 minutes post-dose) |
| Picture recognition reaction time | (ms; lower is better) | Chronic (57 days) |
| Picture recognition reaction time | (ms; lower is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Word recognition accuracy | (%; 0-100; where higher is better) | Acute (45, 180, 300 minutes post-dose) |
| Word recognition accuracy | (%; 0-100; where higher is better) | Chronic (57 days) |
| Word recognition accuracy | (%; 0-100; where higher is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Word recognition reaction time | (ms; lower is better) | Acute (45, 180, 300 minutes post-dose) |
| Word recognition reaction time | (ms; lower is better) | Chronic (57 days) |
| Word recognition reaction time | (ms; lower is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Name to face recall correct responses | number (0-24; higher is better) | Acute (45, 180, 300 minutes post-dose) |
| Name to face recall correct responses | number (0-24; higher is better) | Chronic (57 days) |
| Name to face recall correct responses | number (0-24; higher is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Name to face recall reaction time | (ms; lower is better) | Acute (45, 180, 300 minutes post-dose) |
| Name to face recall reaction time | (ms; lower is better) | Chronic (57 days) |
| Name to face recall reaction time | (ms; lower is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Peg and ball task planning time | (ms; lower is better) | Acute (45, 180, 300 minutes post-dose) |
| Peg and ball task planning time | (ms; lower is better) | Chronic (57 days) |
| Peg and ball task planning time | (ms; lower is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Peg and ball task completion time | (ms; lower is better) | Acute (45, 180, 300 minutes post-dose) |
| Peg and ball task completion time | (ms; lower is better) | Chronic (57 days) |
| Peg and ball task completion time | (ms; lower is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Peg and ball task errors | number (can be any number, lower is better) | Acute (45, 180, 300 minutes post-dose) |
| Peg and ball task errors | number (can be any number, lower is better) | Chronic (57 days) |
| Peg and ball task errors | number (can be any number, lower is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Corsi blocks accuracy | Average scores from the last five correctly completed trials from the corsi block-tapping task | Acute (45, 180, 300 minutes post-dose) |
| Corsi blocks accuracy | Average scores from the last five correctly completed trials from the corsi block-tapping task | Chronic (57 days) |
| Corsi blocks accuracy | Average scores from the last five correctly completed trials from the corsi block-tapping task | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Choice reaction time accuracy | (%; 0-100; where higher is better) | Acute (45, 180, 300 minutes post-dose) |
| Choice reaction time accuracy | (%; 0-100; where higher is better) | Chronic (57 days) |
| Choice reaction time accuracy | (%; 0-100; where higher is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Choice reaction time reaction time | (ms; lower is better) | Acute (45, 180, 300 minutes post-dose) |
| Choice reaction time reaction time | (ms; lower is better) | Chronic (57 days) |
| Choice reaction time reaction time | (ms; lower is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Numeric working memory accuracy | (ms; lower is better) | Acute (45, 180, 300 minutes post-dose) |
| Numeric working memory accuracy | (%; 0-100; where higher is better) | Chronic (57 days) |
| Numeric working memory accuracy | (%; 0-100; where higher is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Numeric working memory reaction time | (ms; lower is better) | Acute (45, 180, 300 minutes post-dose) |
| Numeric working memory reaction time | (ms; lower is better) | Chronic (57 days) |
| Numeric working memory reaction time | (ms; lower is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Serial 3 subtractions total responses | number - calculated from the 3 cycles of the Cognitive Demand Battery; higher is better | Acute (45, 180, 300 minutes post-dose) |
| Serial 3 subtractions total responses | number - calculated from the 3 cycles of the Cognitive Demand Battery; higher is better | Chronic (57 days) |
| Serial 3 subtractions total responses | number - calculated from the 3 cycles of the Cognitive Demand Battery; higher is better | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Serial 3 subtractions total error responses | number - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better | Acute (45, 180, 300 minutes post-dose) |
| Serial 3 subtractions total error responses | number - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better | Chronic (57 days) |
| Serial 3 subtractions total error responses | number - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Serial 7 subtractions total responses | number - calculated from the 3 cycles of the Cognitive Demand Battery; higher is better | Acute (45, 180, 300 minutes post-dose) |
| Serial 7 subtractions total responses | number - calculated from the 3 cycles of the Cognitive Demand Battery; higher is better | Chronic (57 days) |
| Serial 7 subtractions total responses | number - calculated from the 3 cycles of the Cognitive Demand Battery; higher is better | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Serial 7 subtractions total error responses | number - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better | Acute (45, 180, 300 minutes post-dose) |
| Serial 7 subtractions total error responses | number - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better | Chronic (57 days) |
| Serial 7 subtractions total error responses | number - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Rapid visual information processing accuracy | (%) - calculated from the 3 cycles of the Cognitive Demand Battery (%; 0-100; where higher is better) | Acute (45, 180, 300 minutes post-dose) |
| Rapid visual information processing accuracy | (%) - calculated from the 3 cycles of the Cognitive Demand Battery (%; 0-100; where higher is better) | Chronic (57 days) |
| Rapid visual information processing accuracy | (%) - calculated from the 3 cycles of the Cognitive Demand Battery (%; 0-100; where higher is better) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Rapid visual information processing reaction time | (ms) - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better | Acute (45, 180, 300 minutes post-dose) |
| Rapid visual information processing reaction time | (ms) - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better | Chronic (57 days) |
| Rapid visual information processing reaction time | (ms) - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Rapid visual information processing false alarms | number - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better | Acute (45, 180, 300 minutes post-dose) |
| Rapid visual information processing false alarms | number - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better | Chronic (57 days) |
| Rapid visual information processing false alarms | number - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Mental fatigue | visual analogue scale (%) - calculated from the 3 cycles of the Cognitive Demand Battery (0-100; higher indicates more fatigue) | Acute (45, 180, 300 minutes post-dose) |
| Mental fatigue | visual analogue scale (%) - calculated from the 3 cycles of the Cognitive Demand Battery (0-100; higher indicates more fatigue) | Chronic (57 days) |
| Mental fatigue | visual analogue scale (%) - calculated from the 3 cycles of the Cognitive Demand Battery (0-100; higher indicates more fatigue) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Subjective mood - Alert | derived from Bond Lader visual analogue scales (0-100; higher is more alert) | Acute (45, 180, 300 minutes post-dose) |
| Subjective mood - Alert | derived from Bond Lader visual analogue scales (0-100; higher is more alert) | Chronic (57 days) |
| Subjective mood - Alert | derived from Bond Lader visual analogue scales (0-100; higher is more alert) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Subjective mood - Content (visual analogue scale) | derived from Bond Lader visual analogue scales (0-100 higher is more content) | Acute (45, 180, 300 minutes post-dose) |
| Subjective mood - Content | derived from Bond Lader visual analogue scales(0-100 higher is more content) | Chronic (57 days) |
| Subjective mood - Content | derived from Bond Lader visual analogue scales(0-100 higher is more content) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Subjective mood - Calm | derived from Bond Lader visual analogue scales (0-100 higher is more calm) | Acute (45, 180, 300 minutes post-dose) |
| Subjective mood - Calm | derived from Bond Lader visual analogue scale (0-100 higher is more calm) | Chronic (57 days) |
| Subjective mood - Calm (Bond Lader visual analogue scale) | derived from Bond Lader visual analogue scale (0-100 higher is more calm) | Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose) |
| Cerebral blood flow during performance of cognitive tasks | Measured (in umol) using quantitative near infrared spectroscopy (higher indicates increased blood volume) | Acute (120, 150 minutes post-dose) |
| Cerebral blood flow during performance of cognitive tasks | Measured (in umol) using quantitative near infrared spectroscopy (higher indicates increased blood volume) | Superimposed chronic (57 days plus 120, 150 minutes post-dose) |
| Cerebral blood flow at rest | Measured (in umol) using quantitative near infrared spectroscopy (higher indicates increased blood volume) | Acute (120, 150 minutes post-dose) |
| Cerebral blood flow at rest | Measured (in umol) using quantitative near infrared spectroscopy (higher indicates increased blood volume) | Chronic (57 days) |
| Cerebral blood flow at rest | Measured (in umol) using quantitative near infrared spectroscopy (higher indicates increased blood volume) | Superimposed chronic (57 days plus 120, 150 minutes post-dose) |
| Background | Nakamura T, Komai N, Isogami I, Ueno K, Ikegami F, Ono K, Yano S. Memory and learning-enhancing effect of Daikenchuto, a traditional Japanese herbal medicine, in mice.Journal of Natural Medicines 60(1): 64-67, 2006 |