Can six months consumption of daun kesum supplement improve memory, mood and brain function among older adults with memory impairment?
| ISRCTN | ISRCTN12417552 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12417552 |
| Secondary identifying numbers | UKM PPI/111/8/JEP-2016-611 |
- Submission date
- 29/08/2019
- Registration date
- 30/08/2019
- Last edited
- 07/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Public
Centre of Healthy Aging and Wellness
Universiti Kebangsaan Malaysia
Kuala Lumpur
50300
Malaysia
 ORCID ID |
0000-0003-3504-0099 |
|---|---|
| Phone | +60 (0)165077996 |
| P90593@siswa.ukm.edu.my |
Scientific
Centre of Healthy Aging and Wellness
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
| Phone | +60 (0)193326530 |
|---|---|
| suzana.shahar@ukm.edu.my |
Study information
| Study design | Multicentre interventional randomised double-blinded placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| 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(s) | 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 |
| 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 |
| 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 study start date | 01/02/2017 |
| Overall study end date | 15/09/2018 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 36 |
| Total final enrolment | 36 |
| 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 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
Study participating centres
Kuala Lumpur
58200
Malaysia
Batu 6, Jalan Sibu Off , Jalan Ipoh
Kuala Lumpur
51200
Malaysia
Sponsor information
Industry
Lot 21, Jalan U1/19, Section U1
Hicom Glenmarie Industrial Park
Shah Alam
Selangor
40150
Malaysia
| Phone | +60 (0)35565 5600 |
|---|---|
| info@biotropicsmalaysia.com | |
| Website | https://www.biotropicsmalaysia.com/ |
"ROR" |
https://ror.org/00jsvb253 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/10/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/10/2020 | 07/09/2021 | Yes | No |
Editorial Notes
07/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
30/08/2019: Trial's existence confirmed by ethics committee.
