Does an extract of the plant Cosmos caudatus affect cognitive function and other health markers in older adults in Malaysia with mild cognitive impairment?

The effects of Cosmos caudatus (ulam raja) extract in improving cognitive function, brain activity, mood state and health parameters among older adults with mild cognitive impairment

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16793907

Enrollment

Registered

2019-12-20

Start date

2019-05-01

Completion date

Unknown

Last updated

2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive impairment Mental and Behavioural Disorders

Interventions

Name of treatment: Cosmos caudatus extract, Placebo (maltodextrin) The powder form extract was packed into capsules by the repacker from Universiti Teknologi Malaysia, then they packag

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Malaysian older adults aged 60-75 years at the time of informed consent 2. Mild cognitive impairment based on Petersen’s criteria: 2.1. No clinical judgment of dementia 2.2. No or very minimal limitations in Instrumental Activities of Daily Living (IADL) with a score of =1.5 SD from mean norm 2.3. Essentially preserved general cognitive functioning, with a score =19 in Mini Mental State Examination (MMSE) 2.4. Objective memory impairment, with a score of at least 1.5 SD below the mean average in one or more cognitive tests (Rey Auditory Verbal Learning Test [RAVLT] or Digit Span) 3. Able to communicate in Malay or English language 4. Body mass index (BMI) of 20-30 kg/m2

Exclusion criteria

Exclusion criteria: 1. Alcohol and/or substance dependence 2. Smoker 3. Any type of neurodegenerative diseases (i.e. Parkinson disease, dementia, etc) 4. Diagnosis of a depressive disorder, schizophrenia or score >5 in Geriatric Depression Scale (GDS) 5. Any medical conditions that might interfere with the subject’s participation in the trial (i.e. uncontrolled diabetes, chronic heart disease, cancer and kidney, liver or renal failure) 6. Attention Deficit Hyperactivity Disorder (ADHD) or other conditions that might interfere with the outcomes, such as cognition function and psychosocial status 7. Regular consumer of traditional herbs, vitamin and mineral supplementation for the past 6 months, since this might jeopardize the effects of the supplement used in the study 8. Females receiving Hormone Replacement Therapy (HRT) 9. Taking medications which might be interfered with by the product (i.e. warfarin etc.)

Design outcomes

Primary

Measure	Time frame
1. Cognitive impairment assessed using Mini-Mental State Examination (MMSE) at baseline, week 6 and week 12 2. Short-term memory assessed using Digit Span at baseline, week 6 and week 12 3. Verbal memory assessed using validated Malay version of Rey Auditory Verbal Learning Test (RAVLT) at baseline, week 6 and week 12 4. Processing speed assessed using the validated Digit Symbol Substitution Test (DSST) at baseline, week 6 and week 12 5. Visual memory assessed using validated Visual Reproduction at baseline, week 6 and week 12 6. Mood state assessed using using validated Profile of Mood state questionnaire at baseline, week 6 and week 12 7. Brain activity assessed using functional magnetic resonance imaging at baseline and 12 weeks	—

Measure

Time frame

1. Cognitive impairment assessed using Mini-Mental State Examination (MMSE) at baseline, week 6 and week 12 2. Short-term memory assessed using Digit Span at baseline, week 6 and week 12 3. Verbal memory assessed using validated Malay version of Rey Auditory Verbal Learning Test (RAVLT) at baseline, week 6 and week 12 4. Processing speed assessed using the validated Digit Symbol Substitution Test (DSST) at baseline, week 6 and week 12 5. Visual memory assessed using validated Visual Reproduction at baseline, week 6 and week 12 6. Mood state assessed using using validated Profile of Mood state questionnaire at baseline, week 6 and week 12 7. Brain activity assessed using functional magnetic resonance imaging at baseline and 12 weeks

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Secondary

Measure	Time frame
1. Body weight measured using digital weighing scale Tanita HD-309 (Tanita Corporation, Tokyo, Japan) at baseline, week 6 and week 12 2. Standing height measured by using SECA Leicester Portable Height Measure (SECA, Germany) at baseline, week 6 and week 12 3. Waist circumference measured using a flexible, non-extensible Lufkin tape to the nearest 0.1 cm at baseline, week 6 and week 12 4. Hip circumference measured using a flexible, non-extensible Lufkin tape to the nearest 0.1 cm at baseline, week 6 and week 12 5. Body composition measured using bio-electric impedance (BIA) meter (model Inbody S10®) at baseline, week 6 and week 12 6. Blood level of brain-derived neurotrophic factor (BDNF) measured using BDNF Elisa kits at baseline and week 12 7. Blood level of malondialdehyde (MDA), a marker of oxidative stress, measured using MDA Elisa kits at baseline and week 12 8. Blood level of inducible nitric oxide synthase (iNOS) measured using iNOS Elisa kits at baseline and week 12 9. Blood level of cyclooxygenase 2 (COX-2) measured using COX-2 Elisa kits at baseline and week 12 10. Blood level of superoxide dismutase (SOD) measured using SOD Elisa kits at baseline and week 12 11. Full blood count provided by PathLab-Pathology and Clinical Laboratory (M), Sdn Bhd, Klang Valley branch, at baseline and week 12 12. Fasting blood glucose provided by PathLab-Pathology and Clinical Laboratory (M), Sdn Bhd, Klang Valley branch, at baseline and week 12 13. Lipid profile provided by PathLab-Pathology and Clinical Laboratory (M), Sdn Bhd, Klang Valley branch, at baseline and week 12 14. Liver function provided by PathLab-Pathology and Clinical Laboratory (M), Sdn Bhd, Klang Valley branch, at baseline and week 12 15. Renal function provided by PathLab-Pathology	—

Measure

Time frame

1. Body weight measured using digital weighing scale Tanita HD-309 (Tanita Corporation, Tokyo, Japan) at baseline, week 6 and week 12 2. Standing height measured by using SECA Leicester Portable Height Measure (SECA, Germany) at baseline, week 6 and week 12 3. Waist circumference measured using a flexible, non-extensible Lufkin tape to the nearest 0.1 cm at baseline, week 6 and week 12 4. Hip circumference measured using a flexible, non-extensible Lufkin tape to the nearest 0.1 cm at baseline, week 6 and week 12 5. Body composition measured using bio-electric impedance (BIA) meter (model Inbody S10®) at baseline, week 6 and week 12 6. Blood level of brain-derived neurotrophic factor (BDNF) measured using BDNF Elisa kits at baseline and week 12 7. Blood level of malondialdehyde (MDA), a marker of oxidative stress, measured using MDA Elisa kits at baseline and week 12 8. Blood level of inducible nitric oxide synthase (iNOS) measured using iNOS Elisa kits at baseline and week 12 9. Blood level of cyclooxygenase 2 (COX-2) measured using COX-2 Elisa kits at baseline and week 12 10. Blood level of superoxide dismutase (SOD) measured using SOD Elisa kits at baseline and week 12 11. Full blood count provided by PathLab-Pathology and Clinical Laboratory (M), Sdn Bhd, Klang Valley branch, at baseline and week 12 12. Fasting blood glucose provided by PathLab-Pathology and Clinical Laboratory (M), Sdn Bhd, Klang Valley branch, at baseline and week 12 13. Lipid profile provided by PathLab-Pathology and Clinical Laboratory (M), Sdn Bhd, Klang Valley branch, at baseline and week 12 14. Liver function provided by PathLab-Pathology and Clinical Laboratory (M), Sdn Bhd, Klang Valley branch, at baseline and week 12 15. Renal function provided by PathLab-Pathology

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Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026