The effectiveness of a supplement containing standardized Cosmos caudatus extract on memory, mood and cognitive-related biomarkers in the ageing population with mild cognitive impairment

ISRCTN	ISRCTN52580708
DOI	https://doi.org/10.1186/ISRCTN52580708
National Medical Research Register (NMRR) Malaysia	NMRR ID-26-02339-EH
Sponsor	Aurora Health Sdn. Bhd.
Funder	Kementerian Sains, Teknologi dan Inovasi

Submission date: 19/08/2026
Registration date: 14/09/2026
Last edited: 14/09/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The Department of Malaysia Statistics (DOMS) has reported a rising ageing population in Malaysia from 5% in 2010 to 14.5% in 2024. Therefore, the neuroprotective effects of medicinal plants are being explored. This study aims to determine the effectiveness of a standardized Cosmos caudatus supplement on its ability to improve mental well-being after 24 weeks of supplementation among individuals aged 50 years and above with mild cognitive impairment (MCI).

Who can participate?
Malaysians aged 50 years and above with mild cognitive impairment

What does the study involve?
Participants will interviewed to obtain sociodemographic information, health status, lifestyle and diet history. Participants will undergo a series of body, cognitive and blood pressure measurements. During the intervention, participants will be allocated into three groups and will receive either a supplement containing Cosmos caudatus (one of two doses) or a placebo and will be required to take two capsules every day for 24 weeks. Participants are also required to fast the night before after a blood test has been performed during baseline (first visit) and after 24 weeks (third visit). 30 ml of blood will be drawn by a trained phlebotomist. 27 eligible subsample participants will be selected for functional magnetic resonance imaging (fMRI) during baseline (first visit) and after 24 weeks (third visit) to assess brain activation.

What are the possible benefits and risks of participating?
Participants will learn about their health status through body measurements, dietary intake, blood tests and cognitive status. Additionally, participation in this study will contribute to broadening the knowledge and bridging the gap pertaining to MCI in the ageing population. No risks are expected from procedures such as body measurements, answering questionnaires and cognitive assessment using fMRI, which are non-invasive and according to standard procedures. However, participants may have to contribute a portion of their time to take part in this study.

Where is the study run from?
1. Centre for Healthy Ageing and Wellness (H-care) National University of Malaysia Kuala Lumpur Campus (Malaysia)
2. Senior Citizen Activity Centre (PAWE) (Malaysia)
3. Hospital Chancellor Tuanku Mukhriz (HCTM) (Malaysia)

When is the study starting and how long is it expected to run for?
September 2026 to February 2029

Who is funding the study?
Ministry of Science, Technology and Innovation (MOSTI) (Malaysia) (grant number: NN-2025-018)

Who is the main contact?
1. Prof. Dr Suzana Shahar, suzana.shahar@ukm.edu.my
2. Sharifah Miza Iman Binti Syed Hasmadi, p160229@siswa.ukm.edu.my

Contact information

Prof Suzana Shahar
Principal investigator, Scientific

Centre for Healthy Ageing & Wellness (H-CARE)
Faculty of Health Sciences
National University of Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia

Phone	+60 (0)3-9289 7602 / 7370
Email	suzana.shahar@ukm.edu.my

Dr Yee Xing You
Scientific

Centre for Healthy Ageing & Wellness (H-CARE)
Faculty of Health Sciences
National University of Malaysia
Kuala Lumpur
50300
Malaysia

ORCID ID	0000-0002-9876-7634
Phone	+60 (0)16-4472663
Email	youyeexing@ukm.edu.my

Ms Sharifah Miza Iman Syed Hasmadi
Public

Centre for Healthy Ageing & Wellness (H-CARE)
Faculty of Health Sciences
National University of Malaysia
Kuala Lumpur
50300
Malaysia

ORCID ID	0009-0001-0888-124X
Phone	+60 (0)19-3242171
Email	p160229@siswa.ukm.edu.my

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Prevention
Participant information sheet	50120_PIS_Malay.pdf
Scientific title	Efficacy of a supplement containing standardized Cosmos caudatus extract for the mental well-being in the ageing population with mild cognitive impairment: a randomized controlled trial
Study objectives	1.To determine the efficacy of 24 weeks standardized Cosmos caudatus (CC) supplementation on cognitive function using neuropsychological batteries and mood status using Profile of Mood State (POMS) rating among individuals age 50 years and above with MCI. 2.To determine the efficacy of 24 weeks standardized CC supplementation on brain activity associated with working memory and emotion by using functional magnetic resonance imaging (fMRI) among individuals age 50 years and above with MCI. 3.To determine the efficacy of 24 weeks standardized CC supplementation on blood profile and cognitive and related biomarkers among individuals age 50 years and above with MCI.
Ethics approval(s)	Approved 27/07/2026, Medical Research Ethics Committee of the National University of Malaysia (Universiti Kebangsaan Malaysia) (Universiti Kebangsaan Malaysia Research Ethics Secretariat, 1st Floor, Clinical Block, Chancellor Tuanku Muhriz Hospital, UKM Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Kuala Lumpur, 56000, Malaysia; +60 (0)391455046; sepukm@ukm.edu.my), ref: JEP-2026-395
Health condition(s) or problem(s) studied	Mild cognitive impairment (MCI)
Intervention	This study will be a randomized double-blind placebo-controlled trial. Eligible participants will be equally divided into blocks balanced equally by gender and will be randomly assigned to one of three groups (CC250, CC500 and placebo) with an allocation ratio of 1:1:1 using a computerized generator by investigators with no active roles involved in the clinical trials. All participants and investigators directly involved in the clinical trials will be kept blinded from group assignments. CC extract supplements of 250 mg, 500 mg and placebo will be produced in similar size and colour-coded capsules and placed in identical bottles. Participants will be ask to consume two tablets per day for a duration of 24 weeks. Supplement distribution will also be carried out by investigators with no involvement in the clinical trials. The allocation group will be disclosed after the analysis is completed.
Intervention type	Supplement
Primary outcome measure(s)	Cognitive impairment measured using the Montreal Cognitive Assessment (MoCA) at baseline, 12 weeks and 24 weeks Attention and working memory measured using digit span (forward and backward) at baseline, 12 weeks and 24 weeks Episodic verbal memory measured using the Ray Auditory Verbal Learning Test (RAVLT) at baseline, 12 weeks and 24 weeks Nonverbal/visual memory measured using the Visual Reproduction test at baseline, 12 weeks and 24 weeks Visuomotor coordination measured using the Digit Symbol Substitution test at baseline, 12 weeks and 24 weeks Processing speed and cognitive flexibility measured using the Comprehensive Trail Making Test (CTMT) at baseline, 12 weeks and 24 weeks Tension, depression, anger, vigour, fatigue, confusion measured using the Profile of Mood States (POMS) at baseline, 12 weeks and 24 weeks
Key secondary outcome measure(s)	Body composition: weight, fat mass, percent body fat and skeletal muscle mass measured using the Bioelectric Impedance Analyzer (InBody 270) at baseline, 12 weeks and 24 weeks Standing height measured using the SECA Leicester Portable Height Measure (SECA, Germany) at baseline, 12 weeks and 24 weeks Diet history measured using validated dietary questionnaires (Shahar et al, 2000) at baseline, 12 weeks and 24 weeks Fasting blood sugar measured using the PathLab-Pathology and Clinical Laboratory (M), Sdn Bhd at baseline and 24 weeks Lipid profile measured using the PathLab-Pathology and Clinical Laboratory (M), Sdn Bhd at baseline and 24 weeks Liver function test measured using the PathLab-Pathology and Clinical Laboratory (M), Sdn Bhd at baseline and 24 weeks Renal function test measured using the PathLab-Pathology and Clinical Laboratory (M), Sdn Bhd at baseline and 24 weeks Full blood count measured using the PathLab-Pathology and Clinical Laboratory (M), Sdn Bhd at baseline and 24 weeks Apoe e4 measured using ELISA Kits (Elabscience, Houston, Texan, USA) at baseline and 24 weeks Malondialdehyde measured using ELISA Kits (Elabscience, Houston, Texan, USA) at baseline and 24 weeks Brain derived neutrophic factor (BDNF) measured using ELISA Kits (Elabscience, Houston, Texan, USA) at baseline and 24 weeks Glutathione measured using ELISA Kits (Elabscience, Houston, Texan, USA) at baseline and 24 weeks
Completion date	01/02/2029

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	50 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	180
Key inclusion criteria	1. Malaysians aged 50 years and above with body mass index (BMI) 20-30 kg/m² 2. Montreal Cognitive Assessment (MoCA) scores ≤23 3. Have no or very minimal limitations in instrumental activities of daily living (IADL) with a score of ≤1.5 SD from mean norm 4. Objective memory impairment with a score of at least 1.5 SD below the mean average in one or more cognitive test (Rey Auditory Verbal Learning Test (RAVLT) (immediate recall) or Digit Span) 5. Self- and informant-reported memory complaints 6. Able to communicate and understand Malay or English language
Key exclusion criteria	1. Individuals diagnosed with neurodegenerative conditions, severe depression and compulsive substance use 2. Individuals with chronic disease (diabetic patient on medication, chronic kidney disease, hepatitis/liver cirrhosis, cancer) 3. Individuals with physical disability 4. Female participants receiving ongoing hormone replacement therapy (HRT) Functional magnetic resonance imaging (fMRI) subsample: 1. Individuals with ferromagnetic or non-ferrous implanted materials 2. Individuals with claustrophobia 3. Individuals with color blindness
Date of first enrolment	01/09/2026
Date of final enrolment	30/10/2027

Locations

Countries of recruitment

Malaysia

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from Prof.Dr Suzana Shahar (suzana.shahar@ukm.edu.my). Only statistical data will be provided after obtaining consent from the participants. The type of data that will be shared: Data in the published manuscript. Whether consent from participants was required and obtained: Yes. Comments on data anonymization: All patients' data will be confidential.

Individual participant data (IPD) Intention to share

Yes

IPD sharing plan

The datasets generated during and/or analysed during the current study will be available upon request from Prof.Dr Suzana Shahar (suzana.shahar@ukm.edu.my). Only statistical data will be provided after obtaining consent from the participants.
The type of data that will be shared: Data in the published manuscript.
Whether consent from participants was required and obtained: Yes.
Comments on data anonymization: All patients' data will be confidential.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			19/08/2026	No	Yes
Participant information sheet			19/08/2026	No	Yes

Additional files

50120_PIS_English.pdf: Participant information sheet
50120_PIS_Malay.pdf: Participant information sheet

Editorial Notes

27/08/2026: Study's existence confirmed by the Research Ethics Committee Universiti Kebangsaan Malaysia (RECUKM).