Evaluation of safety and effect of food supplement from Polyphenol-Rich Herbal Congee on working memory and cognitive processing in elderly volunteers

Phase 1

Completed

• Conditions: Healthy conditions; tomato pomace; congee; elderly; parkinson' s disease; working memory; cognitive processing

• Registration Number: TCTR20201020003
• Lead Sponsor: amchow (Thailand) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-20
• Study Completion: 2021-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

1.Aged between 60-70 years old
2.Blood pressure <140/90 mmHg and fasting plasma glucose <126 mg/dL

Exclusion Criteria

1.Volunteers who have been diagnosed with cardiovascular diseases, respiratory diseases, neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune diseases and hematological disorder
2.Volunteers who require supplements or herbs or drugs at least 1 months before participating in this study
3.Volunteers who require supplements or any drug that effect on the nervous system by order of the doctor during trial
4.Smoking more than 10 pieces/day
5.Alcohol addiction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
์N100 and P300 8 weeks Event related evoked potentials (ERPs)

Secondary Outcome Measures

Name	Time	Method
Computerized battery test (CDR) 8 weeks computer,Bond Ladder analogue scale 8 weeks Questionnair,Psychologucal symptom using SCL-90 questionnair 8 weeks Questionnair,Dietary questionnaire 8 weeks Questionnair,safety evaluation and side effect 8 weeks Questionnair ,Acetylcholinesterase, Monoamine oxidase (MAO), Monoamine oxidase A and B 8 weeks Elisa methods,Malondialdehyde (MDA), Superoxide dismutase (SOD), Catalase (CAT), Glutathine and peroxidase (GSP-Px 8 weeks Elisa methods,total phenolic compound 8 weeks Elisa methods,The changes of hemetalogical and clinical chemistry parameters 8 weeks laboratory ,Homocysteine 8 weeks laboratory,Alpha-synuclein and DJ-1 8 weeks ELISA Kit ,Stool examination (PH, Lactobacillus spp., Bifidobacterium spp. and Short chain fatty acid) 8 weeks laboratory