The Effects of Chicken Extract and a Peptide Supplement for the Prevention of Cognitive Decline in Non-demented Elderly Adults

Aging Clinical Trial

Official title:

Trial of A Chicken Extract and Peptide Supplement for the Prevention of Cognitive Decline and Mechanisms of Action in Non-demented Elderly Adults: A Multicenter, Two-year, Three-arm, Randomized, Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555655
• Other study ID #: BEC-CMI-003
• Status: Completed
• Phase: Early Phase 1
• Start date: December 11, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2022
• Source: Brand's Suntory Asia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial investigates the effect of a chicken extract supplement and a peptide supplement on cognitive function and potential mechanisms of action of cognitive decline during ageing, among non-demented elderly adults using a three-arm, randomized, placebo-controlled clinical trial design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female at 55 - 75 years of age

• Baseline cognition:

• Normal cognition with feelings of cognitive decline (subjective cognitive decline) OR

• Mild cognitive impairment (MCI+) with memory impairment

• Agree to participate in the study and provide written informed consent

Exclusion Criteria:

• Inadequate visual and auditory acuity to allow neuropsychological testing

• Significant cerebrovascular disease

• History of allergy to chicken meat

• Diagnosis of Alzheimer's disease (AD) with dementia or any other dementia

• Clinical dementia rating (CDR) score of > 0.5 at screening

• Evidence of other neurological, psychiatric or physical illness that can produce cognitive deterioration per investigator's judgment

• Inability or unwillingness to undergo PET scan

• Current diagnosis or history of alcoholism or substance addiction

• Regular use of any medication in the past 6 months that may affect cognitive functioning

• Regular use of cognitive enhancing supplements in the past 6 months

• Subjects with excessive blood donation or blood drawn prior to baseline

• Persons with a history of cardiovascular disease or any other cardiovascular or cerebrovascular diseases which investigators deem unsuitable to participate in the clinical study.

Related Conditions & MeSH terms

• Aging
• Cognitive Decline
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Dietary Supplement:
• Chicken extract supplement
70ml of chicken extract supplement to be consumed daily in the morning before meals for 2 years.
• Peptide Supplement
70ml of Peptide Supplement (670mg) to be consumed daily in the morning before meals for 2 years.

Other:
• Placebo
70ml of placebo (caesinate) to be consumed daily in the morning before meals for 2 years.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital Shuang Ho Hospital	New Taipei City
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Taoyuan Chang Gung Memorial Hospital	Taoyuan

Sponsors (4)

Lead Sponsor	Collaborator
Brand's Suntory Asia	Chang Gung Memorial Hospital, National Cheng-Kung University Hospital, Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Function assessed by Alzheimer's Disease Composite Score (ADCOMS)	Change from baseline in Alzheimer's Disease Composite Score (ADCOMS).; ADCOMS composite score is a weighted linear combination of the 12 items in the Wold's partial least squares (PLS) model. Composite scores range from 0.0 to a maximum of 1.97, where higher values indicate worse performance.	24 months
Primary	Florbetaben (18F) PET Scan Imaging	Change from baseline values in Florbetaben (18F) PET scan	24 months
Secondary	Handgrip strength	Change from baseline in handgrip strength	12 months & 24 months
Secondary	Ratio of plasma tau protein and amyloid-beta 42	Change from baseline in plasma tau protein & amyloid-beta 42 ratio	24 months
Secondary	Alzheimer's Disease Composite Score (ADCOMS)	Change from baseline in Alzheimer's Disease Composite Score (ADCOMS). ADCOMS composite score is a weighted linear combination of the 12 items in the Wold's partial least squares (PLS) model. Composite scores range from 0.0 to a maximum of 1.97, where higher values indicate worse performance.	12 months
Secondary	Blood myeloperoxidase (MPO) levels	Change from baseline in blood myeloperoxidase (MPO) Higher levels of MPO indicate worse oxidative stress status	12 months & 24 months
Secondary	Blood inflammation biomarker levels (hs-CRP, ESR, TNF-a, IL-6)	Change from baseline in inflammation, measured by the following blood biomarkers. Each biomarker will be evaluated individually.; High-sensitivity C-reactive Protein (hs-CRP); Erythrocyte Sedimentation Rate (ESR); Tumor necrosis factor alpha (TNFa); Interleukin 6 (IL-6)	12 months & 24 months
Secondary	Fasting blood glucose level	Change from baseline in fasting blood glucose level	4, 8, 12, 18 and 24 months
Secondary	Taiwanese Depression Questionnaire (TQD) score	Change from baseline in patient-reported Taiwanese Depression Questionnaire (TQD) scores.; TDQ scores range from 0 to 54, with the higher score indicating the greater depression state.	4, 8, 12, 18 and 24 months
Secondary	Short Form-36 (SF-36) Component and Scale Scores	Change from baseline in Short Form-36 (SF-36) Component and Scale Scores. Each scale is directly transformed into a 0 - 100 scale on the assumption that each question carries equal weight. Lower score indicates more disability/worse health status.	4, 8, 12, 18 and 24 months
Secondary	Athens Insomnia Scale (AIS)	Change from baseline in Athens Insomnia Scale Score. A composite score which ranges from 0-24 will be evaluated. Higher score stands for greater severity of insomnia.	4, 8, 12, 18 and 24 months
Secondary	Incidence of infections	Number and incidence of infections occurring during the study period according to a self-reported infection survey	24 months, reported at each study visit (4, 8, 12, 18 and 24 months)
Secondary	Cerebral blood flow measured with sonography	Mean values of cerebral blood flow measured with sonography	12 months & 24 months
Secondary	Blood pressure (systolic blood pressure and diastolic blood pressure)	Change from baseline in systolic and diastolic blood pressure	4, 8, 12, 18 and 24 months