Cognitive ChangeNCT03673930
Cognitive and Cerebral Blood Flow Effects of Zanthozylum Armatum Fruit Extract in Healthy Adults Aged 30 - 55
A study testing Zanthozylum armatum in people with Cognitive Change, run by Northumbria University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Zanthozylum armatum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Apr 2018to 16 Nov 2018
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must self-assess themselves as being in good health
- Aged 30 to 55 years at the time of giving consent
- Are proficient in English equivalent to IELTS band 6 or above
Who cannot join
- Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled (medicated) hypertension, arthritis, asthma, hay fever, high cholesterol and reflux-related conditions. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance
- Are currently taking prescription medications or dietary supplements including omega fatty acids / fish oils NOTE: the explicit exceptions to this are hormone replacement treatments for female participants where symptoms are stable, those medications used in the treatment of arthritis, high blood pressure, high cholesterol and reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, participants may be able to progress to screening
- Have planned a surgery requiring general anaesthesia
- Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
- Have a Body Mass Index (BMI) outside of the range 18-35 kg/m2
- Are pregnant, seeking to become pregnant or lactating
Show all 17Show fewer
- Have learning difficulties, dyslexia
- Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
- Smoker or regular consumption of nicotine containing products e.g. patches, gum, vaping
- Have a history of alcohol or drug abuse
- Excessive caffeine intake (>500 mg per day)
- Have food intolerances/sensitivities, especially against citrus fruits
- Have any health condition that would prevent fulfilment of the study requirements
- Are unable to complete all of the study assessments
- Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
- Do not have a bank account (required for payment)
- Are non-compliant with regards treatment consumption
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria university
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: The Acute and Chronic Cognitive and Cerebral Blood Flow Effects of Zanthozylum Armatum Fruit Extract: a Double Blind, Randomized, Placebo Controlled, Parallel Groups Study in Healthy Humans
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.
Read the detailed description
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-ɑ-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.
- Conditions
- Cognitive Change
- Being tested
- Zanthozylum armatum, Placebo
- Keywords
- NIRS, mood, cognitive performance, Zanthozylum armatum, Nepalese pepper
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zanthozylum armatumDietary supplement
Zanthozylum armatum MCT oil extract
PlaceboDietary supplement
sunflower oil matched for appearance
| Study group | Role | What they receive |
|---|---|---|
| Zanthozylum armatum | Active comparator | fruit extract Receives: Dietary Supplement: Zanthozylum armatum |
| Placebo | Placebo comparator | placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Chronic (57 days)
Secondary outcomes (108)
STAI-trait total score
State-trait anxiety inventory 'trait' score (20-80; higher is more anxious)
Measured: Baseline
STAI-state total score
State-trait anxiety inventory 'state' score (20-80; higher is more anxious)
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Acute (45, 180, 300 minutes post-dose)
Immediate word recall task correctly identified words
total number (0-15; where higher is better)
Measured: Chronic (57 days)
Immediate word recall task correctly identified words
total number (0-15; where higher is better)
Measured: 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)
Measured: Acute (45, 180, 300 minutes post-dose)
Immediate word recall task error responses
total number (can be any number; lower is better)
Measured: Chronic (57 days)
Immediate word recall task error responses
total number (can be any number; lower is better)
Measured: 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)
Measured: Acute (45, 180, 300 minutes post-dose)
Delayed word recall task correctly identified words
total number (0-15; where higher is better)
Measured: Chronic (57 days)
Delayed word recall task correctly identified words
total number (0-15; where higher is better)
Measured: 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)
Measured: Acute (45, 180, 300 minutes post-dose)
Delayed word recall task correctly error responses
total number (can be any number; lower is better)
Measured: Chronic (57 days)
Delayed word recall task correctly error responses
total number (can be any number; lower is better)
Measured: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Picture recognition accuracy
(%; 0-100; where higher is better)
Measured: Acute (45, 180, 300 minutes post-dose)
Picture recognition accuracy
(%; 0-100; where higher is better)
Measured: Chronic (57 days)
Picture recognition accuracy
(%; 0-100; where higher is better)
Measured: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Picture recognition reaction time
(ms; lower is better)
Measured: Acute (45, 180, 300 minutes post-dose)
Picture recognition reaction time
(ms; lower is better)
Measured: Chronic (57 days)
Picture recognition reaction time
(ms; lower is better)
Measured: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Word recognition accuracy
(%; 0-100; where higher is better)
Measured: Acute (45, 180, 300 minutes post-dose)
Word recognition accuracy
(%; 0-100; where higher is better)
Measured: Chronic (57 days)
Word recognition accuracy
(%; 0-100; where higher is better)
Measured: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Word recognition reaction time
(ms; lower is better)
Measured: Acute (45, 180, 300 minutes post-dose)
Word recognition reaction time
(ms; lower is better)
Measured: Chronic (57 days)
Word recognition reaction time
(ms; lower is better)
Measured: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Name to face recall correct responses
number (0-24; higher is better)
Measured: Acute (45, 180, 300 minutes post-dose)
Name to face recall correct responses
number (0-24; higher is better)
Measured: Chronic (57 days)
Name to face recall correct responses
number (0-24; higher is better)
Measured: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Name to face recall reaction time
(ms; lower is better)
Measured: Acute (45, 180, 300 minutes post-dose)
Name to face recall reaction time
(ms; lower is better)
Measured: Chronic (57 days)
Name to face recall reaction time
(ms; lower is better)
Measured: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Peg and ball task planning time
(ms; lower is better)
Measured: Acute (45, 180, 300 minutes post-dose)
Peg and ball task planning time
(ms; lower is better)
Measured: Chronic (57 days)
Peg and ball task planning time
(ms; lower is better)
Measured: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Peg and ball task completion time
(ms; lower is better)
Measured: Acute (45, 180, 300 minutes post-dose)
Peg and ball task completion time
(ms; lower is better)
Measured: Chronic (57 days)
Peg and ball task completion time
(ms; lower is better)
Measured: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Peg and ball task errors
number (can be any number, lower is better)
Measured: Acute (45, 180, 300 minutes post-dose)
Peg and ball task errors
number (can be any number, lower is better)
Measured: Chronic (57 days)
Peg and ball task errors
number (can be any number, lower is better)
Measured: 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
Measured: 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
Measured: Chronic (57 days)
Corsi blocks accuracy
Average scores from the last five correctly completed trials from the corsi block-tapping task
Measured: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Choice reaction time accuracy
(%; 0-100; where higher is better)
Measured: Acute (45, 180, 300 minutes post-dose)
Choice reaction time accuracy
(%; 0-100; where higher is better)
Measured: Chronic (57 days)
Choice reaction time accuracy
(%; 0-100; where higher is better)
Measured: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Choice reaction time reaction time
(ms; lower is better)
Measured: Acute (45, 180, 300 minutes post-dose)
Choice reaction time reaction time
(ms; lower is better)
Measured: Chronic (57 days)
Choice reaction time reaction time
(ms; lower is better)
Measured: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Numeric working memory accuracy
(ms; lower is better)
Measured: Acute (45, 180, 300 minutes post-dose)
Numeric working memory accuracy
(%; 0-100; where higher is better)
Measured: Chronic (57 days)
Numeric working memory accuracy
(%; 0-100; where higher is better)
Measured: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Numeric working memory reaction time
(ms; lower is better)
Measured: Acute (45, 180, 300 minutes post-dose)
Numeric working memory reaction time
(ms; lower is better)
Measured: Chronic (57 days)
Numeric working memory reaction time
(ms; lower is better)
Measured: 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
Measured: 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
Measured: Chronic (57 days)
Serial 3 subtractions total responses
number - calculated from the 3 cycles of the Cognitive Demand Battery; higher is better
Measured: 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
Measured: 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
Measured: Chronic (57 days)
Serial 3 subtractions total error responses
number - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better
Measured: 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
Measured: 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
Measured: Chronic (57 days)
Serial 7 subtractions total responses
number - calculated from the 3 cycles of the Cognitive Demand Battery; higher is better
Measured: 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
Measured: 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
Measured: Chronic (57 days)
Serial 7 subtractions total error responses
number - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better
Measured: 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)
Measured: 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)
Measured: Chronic (57 days)
Rapid visual information processing accuracy
(%) - calculated from the 3 cycles of the Cognitive Demand Battery (%; 0-100; where higher is better)
Measured: 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
Measured: 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
Measured: Chronic (57 days)
Rapid visual information processing reaction time
(ms) - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better
Measured: 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
Measured: 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
Measured: Chronic (57 days)
Rapid visual information processing false alarms
number - calculated from the 3 cycles of the Cognitive Demand Battery; lower is better
Measured: 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)
Measured: 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)
Measured: Chronic (57 days)
Mental fatigue
visual analogue scale (%) - calculated from the 3 cycles of the Cognitive Demand Battery (0-100; higher indicates more fatigue)
Measured: 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)
Measured: Acute (45, 180, 300 minutes post-dose)
Subjective mood - Alert
derived from Bond Lader visual analogue scales (0-100; higher is more alert)
Measured: Chronic (57 days)
Subjective mood - Alert
derived from Bond Lader visual analogue scales (0-100; higher is more alert)
Measured: 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)
Measured: Acute (45, 180, 300 minutes post-dose)
Subjective mood - Content
derived from Bond Lader visual analogue scales(0-100 higher is more content)
Measured: Chronic (57 days)
Subjective mood - Content
derived from Bond Lader visual analogue scales(0-100 higher is more content)
Measured: 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)
Measured: Acute (45, 180, 300 minutes post-dose)
Subjective mood - Calm
derived from Bond Lader visual analogue scale (0-100 higher is more calm)
Measured: Chronic (57 days)
Subjective mood - Calm (Bond Lader visual analogue scale)
derived from Bond Lader visual analogue scale (0-100 higher is more calm)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Acute (120, 150 minutes post-dose)
Cerebral blood flow at rest
Measured (in umol) using quantitative near infrared spectroscopy (higher indicates increased blood volume)
Measured: Chronic (57 days)
Cerebral blood flow at rest
Measured (in umol) using quantitative near infrared spectroscopy (higher indicates increased blood volume)
Measured: Superimposed chronic (57 days plus 120, 150 minutes post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start6 Apr 2018
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Mibelle AG
- Responsible party
- Sponsor
- Investigators
- Philippa A Jackson, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673930
- Sponsor's protocol ID
- 53BS1
- Status last verified
- Jan 2019
- First submitted
- 13 Sep 2018
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20041426Kalia NK, Singh B, Sood RP. A new amide from zanthoxylum armatum. J Nat Prod. 1999 Feb;62(2):311-2. doi: 10.1021/np980224j.
PubMed 10075770Nakamura 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute and Chronic Cognitive and Cerebral Blood Flow Effects of Zanthozylum Armatum Fruit Extract: a Double Blind, Randomized, Placebo Controlled, Parallel Groups Study in Healthy Humans
- ClinicalTrials.gov ID
- NCT03673930
- Acronym / sponsor ID
- 53BS1
- Conditions
- Cognitive Change
- Keywords
- NIRS, mood, cognitive performance, Zanthozylum armatum, Nepalese pepper
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Mibelle AG
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 17 Sep 2018 (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.
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.
Detailed description
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-ɑ-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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zanthozylum armatum | Active comparator | Dietary Supplement: Zanthozylum armatumfruit extract |
| Placebo | Placebo comparator | Dietary Supplement: Placeboplacebo |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must self-assess themselves as being in good health
- Aged 30 to 55 years at the time of giving consent
- Are proficient in English equivalent to IELTS band 6 or above
Key exclusion criteria (17 listed)
- Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled (medicated) hypertension, arthritis, asthma, hay fever, high cholesterol and reflux-related conditions. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance
- Are currently taking prescription medications or dietary supplements including omega fatty acids / fish oils NOTE: the explicit exceptions to this are hormone replacement treatments for female participants where symptoms are stable, those medications used in the treatment of arthritis, high blood pressure, high cholesterol and reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, participants may be able to progress to screening
- Have planned a surgery requiring general anaesthesia
- Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
- Have a Body Mass Index (BMI) outside of the range 18-35 kg/m2
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 |
|---|---|---|
| Zanthozylum armatumZanthozylum armatum MCT oil extract | Dietary supplement | Zanthozylum armatum |
| Placebosunflower oil matched for appearance | Dietary supplement | Placebo |
Primary outcome
Secondary memory score
Time frame: Chronic (57 days)
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).
108 secondary outcomes
STAI-trait total score
Time frame: Baseline
STAI-state total score
Time frame: Chronic (57 days)
Secondary memory score
Time frame: Acute (45, 180, 300 minutes post-dose)
Secondary memory score
Time frame: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Working memory score
Time frame: Chronic (57 days)
Working memory score
Time frame: Acute (45, 180, 300 minutes post-dose)
Working memory score
Time frame: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Speed of memory score
Time frame: Acute (45, 180, 300 minutes post-dose)
Speed of memory score
Time frame: Chronic (57 days)
Speed of memory score
Time frame: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Accuracy of attention score
Time frame: Acute (45, 180, 300 minutes post-dose)
Accuracy of attention score
Time frame: Chronic (57 days)
Accuracy of attention score
Time frame: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Speed of attention score
Time frame: Acute (45, 180, 300 minutes post-dose)
Speed of attention score
Time frame: Chronic (57 days)
Speed of attention score
Time frame: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Immediate word recall task correctly identified words
Time frame: Acute (45, 180, 300 minutes post-dose)
Immediate word recall task correctly identified words
Time frame: Chronic (57 days)
Immediate word recall task correctly identified words
Time frame: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Immediate word recall task error responses
Time frame: Acute (45, 180, 300 minutes post-dose)
Immediate word recall task error responses
Time frame: Chronic (57 days)
Immediate word recall task error responses
Time frame: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Delayed word recall task correctly identified words
Time frame: Acute (45, 180, 300 minutes post-dose)
Delayed word recall task correctly identified words
Time frame: Chronic (57 days)
Delayed word recall task correctly identified words
Time frame: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Delayed word recall task correctly error responses
Time frame: Acute (45, 180, 300 minutes post-dose)
Delayed word recall task correctly error responses
Time frame: Chronic (57 days)
Delayed word recall task correctly error responses
Time frame: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Picture recognition accuracy
Time frame: Acute (45, 180, 300 minutes post-dose)
Picture recognition accuracy
Time frame: Chronic (57 days)
Picture recognition accuracy
Time frame: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Picture recognition reaction time
Time frame: Acute (45, 180, 300 minutes post-dose)
Picture recognition reaction time
Time frame: Chronic (57 days)
Picture recognition reaction time
Time frame: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Word recognition accuracy
Time frame: Acute (45, 180, 300 minutes post-dose)
Word recognition accuracy
Time frame: Chronic (57 days)
Word recognition accuracy
Time frame: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
Word recognition reaction time
Time frame: Acute (45, 180, 300 minutes post-dose)
Word recognition reaction time
Time frame: Chronic (57 days)
Word recognition reaction time
Time frame: Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)
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 24 Jan 2019.
- Background: PubMed 20041426Gilani 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.
- Background: PubMed 10075770Kalia NK, Singh B, Sood RP. A new amide from zanthoxylum armatum. J Nat Prod. 1999 Feb;62(2):311-2. doi: 10.1021/np980224j.
- BackgroundNakamura 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
- Link to study site websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Philippa A Jackson, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zanthozylum armatum in people with Cognitive Change, run by Northumbria University at 1 site in United Kingdom.
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 17 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 24 Jan 2019. 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 Kingdom. 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?
Secondary memory score (time frame: Chronic (57 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03673930, which also lists 3 linked publications.
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 24 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.