Condition category
Mental and Behavioural Disorders
Date applied
29/08/2019
Date assigned
30/08/2019
Last edited
30/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Kesum leaves (scientific name Persicaria Minor) can be found widely in Malaysia. They are a rich natural source of antioxidant, antimicrobial, and antiulcer activities. Previously, research on the effects of Persicaria Minor supplementation on cognitive and psychosocial functions has shown the benefits of the herbal extract at improving cognitive and psychosocial functions of middle-aged women. This successful pilot project has encouraged further research to determine the effects of P. Minor extracts on cognitive function, mood state, selected biomarkers and brain activity of older adults with mild cognitive impairment.

Who can participate?
Malaysian older adults aged 60-75 with mild cognitive impairment

What does the study involve?
Participants are randomly allocated to consume either P. Minor extract or placebo (a substance that has no therapeutic effect, used as a control). Participants consume two capsules per day for 6 months. They need to attend three visits, consisting of a screening visit in early stage, third and sixth months of the study. In all three visits, a series of questionnaires to assess cognitive function, mood state and dietary intake, as well as body measurements are carried out. 20 ml of blood and urine sampling is performed in the early stage and sixth month. Subsamples of participants are selected randomly for an fMRI scan to detect brain activity in the early stage and sixth month.

What are the possible benefits and risks of participating?
Side effects are possible but participants may have none at all. There is unlikely to be a direct benefit of participating in this study. The supplements given have the potential to improve cognitive function and mood, as well as decrease oxidative stress. Nevertheless, the study of the effects of P. Minor on cognitive function, mood state and oxidative stress may have an impact on the importance and benefits of the use of plants as a natural resource in disease prevention and health.

Where is the study run from?
1. Senior Citizen Centre Seputeh (Pusat Aktiviti Warga Emas PAWE Seputeh)
2. Senior Citizen Centre Batu (Pusat Aktiviti Warga Emas PAWE Batu)

When is the study starting and how long is it expected to run for?
February 2017 to September 2018

Who is funding the study?
Biotropics Malaysia Berhad

Who is the main contact?
1. Prof. Dr Suzana Shahar
suzana.shahar@ukm.edu.my
2. Ms Lau Hui Jin
lauhuijin1990@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Miss Huijin Lau

ORCID ID

http://orcid.org/0000-0003-3504-0099

Contact details

Centre of Healthy Aging and Wellness
Universiti Kebangsaan Malaysia
Kuala Lumpur
50300
Malaysia
+60 (0)165077996
P90593@siswa.ukm.edu.my

Type

Scientific

Additional contact

Prof Suzana Shahar

ORCID ID

Contact details

Centre of Healthy Aging and Wellness
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
+60 (0)193326530
suzana.shahar@ukm.edu.my

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

UKM PPI/111/8/JEP-2016-611

Study information

Scientific title

The effects of six months Persicaria Minor supplementation on cognitive function, mood, fMRI brain activity and biomarkers among older adults with mild cognitive impairment

Acronym

Study hypothesis

Six months Persicaria Minor supplementation has the potential to improve cognitive function, mood state, brain activation via fMRI and selected biomarkers.

Ethics approval

Approved 11/01/2017, Research Ethics Committee, The National University Malaysia (1st floor, Clinical Block Hospital Canselor Tunku Muhriz, Universiti Kebangsaan Malaysia, Jalan Yaacob Latiff, Bandar Tun Razak 55000, Kuala Lumpur, Malaysia), ref: UKM PPI/111/8/JEP-2016-611

Study design

Multicentre interventional randomised double-blinded placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Mild cognitive impairment

Intervention

The supplements capsule is a standardised water extract of P.minor with a very high level of antioxidant properties and are a good source of natural antioxidants. A finished product in the form of capsule which contains 250 mg of Biokesum® extract was developed and registered with the National Pharmaceutical Control Bureau (NPCB) with a registration number of MAL14015033T. The placebo used in this study is a 280 mg sensory-identical capsule composed of maltodextrin. Two capsules of P.minor or placebo were taken daily by the subjects after either breakfast or lunch for six months.

Group allocation was based on simple randomization method using an online randomizer. All study personnel and participants were blinded to the study product during the study. Blinding procedure was ensured by labelling the P.minor supplement and placebo capsules as either A or B. Only manufacturer and repacker know the coding for both A and B labelled capsules.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Cognitive function and mood state of older adults with MCI:
1. A series of neurocognitive tests (Mini Mental State of Examination, Digit Span, Rey Auditory Verbal Learning Test, Digit Symbol and Visual Reproduction) were used to assess global cognitive function, working and episodic memory, cognitive processing speed and visual memory of the participants
2. Their mood for the past seven days was also accessed using Profile of Mood State (POMS) questionnaire
Measured at baseline, 3rd month and 6th month of the study

Secondary outcome measures

Measured at baseline and 6th month of the study:
1. Oxidative stress markers (lipid hydroperoxide and malondialdehyde MDA), inflammation markers (inducible nitric oxide synthase iNOS and cyclooxygenase-2 COX-2), brain-derived neurotrophic factor (BDNF), blood glucose and lipid levels. The blood markers were analysed using ELISA method.
2. Brain activation examined via fMRI

Overall trial start date

01/02/2017

Overall trial end date

15/09/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Malaysian older adults age between 60-75 years at the time of informed consent
2. BMI between 20-30 kg/m2
3. MCI based on Peterson criteria

Participant type

Other

Age group

Senior

Gender

Both

Target number of participants

36

Participant exclusion criteria

1. Alcohol and/or substance dependence
2. Had any type of neurodegenerative diseases (i.e. Parkinson disease, Alzheimer’s disease, dementia)
3. Had a diagnosis of a depressive disorder, schizophrenia or score > 5 in Geriatric Depression Scale (GDS)
4. Had any medical conditions might interfere with the subject’s participation in the trial (i.e. serious diabetes, chronic heart disease, cancer and kidney, liver or renal failure
5. Had Attention Deficit Hyperactivity Disorder (ADHD). These conditions might interfere with the outcome such as cognition function and psychosocial status
6. Regular consumer of traditional herbs, vitamin and mineral supplementation for the past six months because it will jeopardize the effect of supplement used in the study
7. Had a metallic implant, such as prostheses, shrapnel or aneurysm clips, or electronic implants, such as cardiac pacemakers
8. Claustrophobic
9. On Hormone Replacement Therapy (HRT)

Recruitment start date

10/03/2017

Recruitment end date

04/10/2017

Locations

Countries of recruitment

Malaysia

Trial participating centre

Senior Citizen Centre Seputeh (Pusat Aktiviti Warga Emas PAWE Seputeh)
Ppr Kg Muhibbah
Kuala Lumpur
58200
Malaysia

Trial participating centre

Senior Citizen Centre Batu (Pusat Aktiviti Warga Emas PAWE Batu)
Projek Perumahan Rakyat (PPR) Taman Wahyu Batu 6, Jalan Sibu Off , Jalan Ipoh
Kuala Lumpur
51200
Malaysia

Sponsor information

Organisation

Biotropics Malaysia Berhad

Sponsor details

Lot 21
Jalan U1/19
Section U1
Hicom Glenmarie Industrial Park
Shah Alam
Selangor
40150
Malaysia
+60 (0)35565 5600
info@biotropicsmalaysia.com

Sponsor type

Industry

Website

https://www.biotropicsmalaysia.com/

Funders

Funder type

Industry

Funder name

Biotropics Malaysia Berhad

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trial results are estimated to be published by the fourth quarter of 2019. Study protocol, statistical plan and consent form will be available.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Ms Lau Hui Jin (lauhuijin90@gmail.com) or Prof. Suzana Shahar (suzana.shahar@ukm.edu.my) or Biotropics Malaysia Berhad (info@biotropicsmalaysia.com). Data will be made available immediately after publication with no end date. Individual participant data that underlie the results reported in the future published article will be shared after deidentification including text, tables, figures and appendices. Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the proposal. To gain data access, the data requesters should contact the person in charge as stated above.
Consent was obtained from all the subjects prior to the trial.

Intention to publish date

01/10/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/08/2019: Trial's existence confirmed by ethics committee.