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Effects of 12 Weeks Cosmos caudatus Supplement among Older Adults with Mild Cognitive Impairment: A Randomized, Double-Blind and Placebo-Controlled Trial.

ABSTRACT: Cosmos caudatus (CC) contains high flavonoids and might be beneficial in neuroprotection. It has the potential to prevent neurodegenerative diseases. Therefore, we aimed to investigate the effects of 12 weeks of Cosmos caudatus supplement on cognitive function, mood status, blood biochemical profiles and biomarkers among older adults with mild cognitive impairment (MCI) through a double-blind, placebo-controlled trial. The subjects were randomized into CC supplement (n = 24) and placebo group (n = 24). Each of them consumed one capsule of CC supplement (250 mg of CC/capsule) or placebo (500 mg maltodextrin/capsule) twice daily for 12 weeks. Cognitive function and mood status were assessed at baseline, 6th week, and 12th week using validated neuropsychological tests. Blood biochemical profiles and biomarkers were measured at baseline and 12th week. Two-way mixed analysis of variance (ANOVA) analysis showed significant improvements in mini mental state examination (MMSE) (partial ?² = 0.150, p = 0.049), tension (partial ?² = 0.191, p = 0.018), total mood disturbance (partial ?² = 0.171, p = 0.028) and malondialdehyde (MDA) (partial ?² = 0.097, p = 0.047) following CC supplementation. In conclusion, 12 weeks CC supplementation potentially improved global cognition, tension, total mood disturbance, and oxidative stress among older adults with MCI. Larger sample size and longer period of intervention with incorporation of metabolomic approach should be conducted to further investigate the underlying mechanism of CC supplementation in neuroprotection.

SUBMITTER: You YX

PROVIDER: S-EPMC7912368 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Effects of 12 Weeks Cosmos caudatus Supplement among Older Adults with Mild Cognitive Impairment: A Randomized, Double-Blind and Placebo-Controlled Trial.

You Yee Xing YX Shahar Suzana S Rajab Nor Fadilah NF Haron Hasnah H Yahya Hanis Mastura HM Mohamad Mazlyfarina M Din Normah Che NC Maskat Mohamad Yusof MY

Nutrients 20210129 2

Cosmos caudatus (CC) contains high flavonoids and might be beneficial in neuroprotection. It has the potential to prevent neurodegenerative diseases. Therefore, we aimed to investigate the effects of 12 weeks of Cosmos caudatus supplement on cognitive function, mood status, blood biochemical profiles and biomarkers among older adults with mild cognitive impairment (MCI) through a double-blind, placebo-controlled trial. The subjects were randomized into CC supplement (n = 24) ...[more]

PMID: 33572715

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Project description:BackgroundMild cognitive impairment (MCI) is considered an intermediate phase between normal aging and dementia. As the majority of cases of amnestic MCI (aMCI) progress to Alzheimer's disease (AD), it is considered the prodromal stage of AD, and a treatment target for prevention of further cognitive decline. However, no medications have been shown to have symptomatic or preventive benefits in MCI. Kami-guibi-tang (KGT) is a traditional herbal formula used in Korean medicine to treat amnesia, which is reported to increase acetylcholine levels via activation of choline acetyltransferase. The objective of this study was to evaluate the efficacy and safety of KGT in patients with aMCI.MethodsThis study was designed as a single-center, randomized, double-blind, placebo-controlled pilot study. Participants diagnosed with aMCI were randomized to receive either KGT or placebo granules for 24 weeks. The efficacy measure was a change in the Seoul Neuropsychological Screening Battery (SNSB) score. The safety measures included the occurrence of adverse events and abnormalities in vital signs and blood chemistry, electrocardiogram (ECG), and brain magnetic resonance imaging (MRI) findings.ResultsA total of 16 patients in the KGT group and 14 patients in the placebo group were investigated in the study. The mean score of Clinical Dementia Rating-Sum of Boxes (CDR-SB) significantly improved from 1.53 (0.64) points to 1.13 (0.62) points in the KGT group (p = 0.010), whereas it worsened from 1.61 (0.88) points to 1.75 (0.94) points in the placebo group. There was a significant difference in the CDR-SB scores between the two groups after the intervention (p = 0.045). The total SNSB-D scores and the scores in the memory domain after the treatment were significantly higher than the baseline values in the KGT group, but not in the placebo group. The frequency of adverse events was not significantly different between the two groups, and there were no abnormalities in vital signs or blood test, ECG, and brain MRI findings after the intervention.ConclusionsKGT may provide a safe and effective treatment option for patients with aMCI. Further studies with a larger sample size are needed to validate the findings.Trial registrationKorean Clinical Trial Registry, ID: KCT0002407; Registered on March 30, 2017, http://cris.nih.go.kr/.

Project description:BackgroundMild cognitive impairment (MCI) is a syndrome characterised by a decline in cognition but relatively intact activities of daily living. People with MCI have an increased risk of developing dementia, and MCI is often referred to as a transitional stage between healthy ageing and dementia. Currently, there are no pharmaceutical therapies approved by the US Federal Drug Administration for MCI. Randomised controlled trials on the two major classes of anti-dementia pharmaceuticals, cholinesterase inhibitors and glutamate receptor antagonists, have produced poor results in MCI cohorts. There is a need to test and evaluate new and promising treatments for MCI that target multiple aspects of the syndrome's multi-faceted pathophysiology. The primary aim of this study is to evaluate the efficacy of 12 weeks of treatment with a standardised herbal formula, Sailuotong (SLT), compared to placebo, on cognition in older adults with MCI. Secondary aims are to assess SLT's mechanisms of action via electroencephalography (EEG), autonomic function, brain blood flow, and inflammation, as well as its safety in this cohort.Methods/designThe target cohort for this trial is community-dwelling older adults over the age of 60 years who meet the National Institute of Aging-Alzheimer's Association working group core clinical criteria for MCI due to Alzheimer's disease. Eighty participants will be recruited and randomly allocated via a permuted block strategy at a 1:1 ratio to either the treatment or placebo group. The co-primary cognitive outcome measures are Logical Memory Story A delayed recall (episodic memory), Letter Number Sequencing (perceptual processing speed), and both the Trail Making Test and Rey Complex Figure Test (executive function). Secondary outcome measures are EEG activity, autonomic function (via electrocardiogram, skin conductance, and peripheral pulse pressure), brain blood flow (via common carotid artery ultrasound), and serum concentrations of inflammatory cytokines. Analyses will be performed blind to group allocation.DiscussionThis study is a 12-week, randomised, double-blind, placebo-controlled trial. Primary and secondary outcome measures will be compared between treatment and placebo groups at baseline and endpoint. Data from this pilot study will inform a larger, more highly powered clinical trial if the findings are positive.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000371392 Registered on 10 March 2017.

Project description:BACKGROUND:Persicaria minor extract exhibits antioxidant and anti-inflammatory properties and has potential effects on cognitive function and mood. However, the effects of P.minor on brain activation and biomarkers have not been studied among older adults. This multicentre, randomized, double-blinded, placebo-controlled study aimed to investigate the effect of 6 months P.minor extract supplement (Biokesum®) on cognition, mood, biomarkers, and brain activation among older adults with Mild Cognitive Impairment (MCI). METHOD:A total of 36 Malaysian community-dwelling older adults with MCI (60-75-year-old) were randomized into Biokesum® (n?=?18) and placebo group (n?=?18). Each subject consumed one capsule of Biokesum® (250?mg/capsule) or placebo (maltodextrin, 280?mg/capsule) twice daily for 6 months. Cognitive function and mood were assessed at baseline, 3rd, and 6th-month using neuropsychological tests (MMSE, Digit Span, RAVLT, Digit Symbol, and Visual Reproduction) and Profile of Mood State (POMS) questionnaire. Blood lipid profile, fasting blood glucose, and biomarkers (MDA, LPO, COX-2, iNOS, and BDNF) were measured at baseline and 6th month. By the end of the intervention, there were 30 compliers (Biokesum®: N?=?15; Placebo: N?=?15) and 6 dropouts. For brain activation assessment, 15 subsamples (Biokesum®: N?=?8; Placebo: N?=?7) completed N-back and Stroop tasks during fMRI scanning at baseline and 6th month. The dorsolateral prefrontal cortex (Brodmann's area 9 and 46) was identified as a region of interest (ROI) for brain activation analysis using SPM software. RESULTS:Two-way mixed ANOVA analysis showed significant improvements in Visual Reproduction II (p?=?0.012, partial ?2?=?0.470), tension (p?=?0.042, partial ?2?=?0.147), anger (p?=?0.010, partial ?2?=?0.207), confusion (p?=?0.041, partial ?2?=?0.148), total negative subscales (p?=?0.043, partial ?2?=?0.145), BDNF (p?=?0.020, partial ?2?=?0.179) and triglyceride (p?=?0.029, partial ?2?=?0.237) following 6 months of Biokesum® supplementation. Preliminary finding also demonstrated significant improvement at 0-back task-induced right DLPFC activation (p?=?0.028, partial ?2?=?0.652) among subsamples in Biokesum® group. No adverse events were reported at the end of the study. CONCLUSION:Six months Biokesum® supplementation potentially improved visual memory, negative mood, BDNF, and triglyceride levels among older adults with MCI. Significant findings on brain activation at the right DPLFC must be considered as preliminary. TRIAL REGISTRATION:Retrospectively registered on 30th August 2019 [ ISRC TN12417552 ].

Dataset Information

Effects of 12 Weeks Cosmos caudatus Supplement among Older Adults with Mild Cognitive Impairment: A Randomized, Double-Blind and Placebo-Controlled Trial.

Publications

Effects of 12 Weeks <i>Cosmos caudatus</i> Supplement among Older Adults with Mild Cognitive Impairment: A Randomized, Double-Blind and Placebo-Controlled Trial.

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