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Evaluation of safety and effect of Morus alba leaf extract mixed with Persicaria odorata on cognitive processing in elderly volunteers

Phase 1
Recruiting
Conditions
healthy conditions
Registration Number
TCTR20210316013
Lead Sponsor
MARK ONE INNOVATION CENTER COMPANY LIMITED
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
75
Inclusion Criteria

1.Aged between 60-70 years old
2.Body Mass Index (BMI) 18.5-25 kg/m2
3.Blood pressure less than 140/90 mm Hg and Fasting Blood Sugar (FBS) after fasts for 8 hours less than 126 mg/dL

Exclusion Criteria

1.Volunteers who have been diagnosed with one of the following; cardiovascular diseases, respiratory diseases, neuropsychological diseases, liver disease, autoimmune disease and hematological disorder
2.Volunteers who require supplements or any drug that effect on the nervous system by order of the doctor before trial
3.Volunteers who use hormone or any drug that effect on the nervous system and skeletal system before trial
4.Smoking more than 10 pieces/ day
5.Drinking alcohol more than 5 times/ day
6.Volunteers who participate in other projects

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
100 and P300 Event related evoked potentials (ERPs) Event related evoked potentials (ERPs)
Secondary Outcome Measures
NameTimeMethod
Working memory test 8 weeks Computerized batteries test ,Acetylcholinesterase and Monoamine oxidase enzyme (MAOA and MAOB) 8 weeks Laboratory,Oxidative stress markers include Malondialdehyde (MDA), Superoxide dismutase (SOD), Catalase (CAT) and Glutathione peroxidase (GSH-Px) 8 weeks Laboratory,Serum bone markers include Osteocalcin, Calcium and Beta CTX 8 weeks Laboratory,The changes of hematological and clinical chemistry parameters 8 weeks Laboratory,Stool examination (PH, Total lactic acid, Bifidobacterial, Short chain fatty acid) 8 weeks Laboratory,Evaluation of sleep quality 8 weeks Pittsburgh Sleep Quality Index questionnaire,Evaluation of Stress 8 weeks Perceived Stress Scale - PSS questionnaire,The changes of electrocardiogram 8 weeks Electrocardiography
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