Cognitive and Cerebral Blood Flow Effects of Zanthozylum Armatum Fruit Extract in Healthy Adults Aged 30 - 55

NCT03673930 | Completed

• 1 other identifier: 53BS1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Change

Keywords

NIRS; mood; cognitive performance; Zanthozylum armatum; Nepalese pepper

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (108)

• STAI-trait total score

  Baseline

• STAI-state total score

  Chronic (57 days)

• Secondary memory score

  Acute (45, 180, 300 minutes post-dose)

• Secondary memory score

  Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose)

• Working memory score

  Chronic (57 days)

Study Arms (2)

Zanthozylum armatum

ACTIVE COMPARATOR

fruit extract

Dietary Supplement: Zanthozylum armatum

Placebo

PLACEBO COMPARATOR

placebo

Dietary Supplement: Placebo

Interventions

Zanthozylum armatum DIETARY_SUPPLEMENT

Zanthozylum armatum MCT oil extract

Zanthozylum armatum

Placebo DIETARY_SUPPLEMENT

sunflower oil matched for appearance

Placebo

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Northumbria University: lead
• Mibelle AG: collaborator

Study Sites (1)

Northumbria university

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 20041426 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.

  PMID: 10075770 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

  BACKGROUND

Related Links

• Link to study site website

Study Officials

• Philippa A Jackson, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: April 6, 2018
• Primary Completion: November 16, 2018
• Study Completion: November 16, 2018
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)