Effect of cashew nut protein hydrolysate plus fiber on changes of cognitive function in middle age and elderly volunteers

Phase 1

Completed

• Conditions: Healthy conditions; Cashew nut; Protein hydrolysate; Cognitive function; Middle age; Elderly

• Registration Number: TCTR20201222004
• Lead Sponsor: Food Innopolis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-22
• Study Completion: 2021-12-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Aged between 45-70 years old
2. Body Mass Index (BMI) 18.5-25 kg/m2

Exclusion Criteria

1.Volunteers who have serious physical illness such as cardiovascular diseases, respiratory diseases, neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune diseases and hematological disorder
2.Volunteers who have been Hysterectomy and/or Oophorectomy
3.Volunteers who require supplements or any drug that effect on hypothalamic pituitary gonadal axis
4.Volunteers who require supplements or any drug that effect on the nervous system by order of the doctor during trial
5.Volunteers who have a regular exercise more than 3 times/week
6.Smoking more than 10 pieces/day
7.Alcohol addiction
8.Volunteers who participate in other projects.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Working memory test 8 weeks Computer,Acetylcholinesterase and Monoamine oxidase enzyme (MAOA and MAOB) 8 weeks Elisa method,The changes of Aging Marker (Telomere length) 8 weeks laboratory,Inflammatory markers include IL-6 and TNF-α 8 weeks Elisa method,Immune markers include CD4, CD8 and CD28 8 weeks Elisa method,The changes of hematological and clinical chemistry parameters 8 weeks laboratory,The changes of beta-galactosidase enzyme 8 weeks Elisa method,The changes of atherosclerosis marker (homocysteine) 8 weeks laboratory,Metabolic parameters include HOMA-IR index, atherosclerosis index and oxidized LDL 8 weeks laboratory,Mood evaluation using Bond-ladder questionnaire 8 weeks Questionnaire,Psychological symptom using SCL-90 questionnaire 8 weeks Questionnaire,Anxiety, depression and insomnia evaluation using questionnaire 8 weeks Questionnaire,Stool examination (PH, Total lactic acid, Bifidobacterial, Short chain fatty acid) 8 weeks laboratory