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

Primary Purpose

Cognitive Decline, Mild Cognitive Impairment, Aging

Status
Completed
Phase
Early Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Chicken extract supplement
Peptide Supplement
Placebo
Sponsored by
Brand's Suntory Asia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Taipei Medical University Hospital Shuang Ho Hospital
  • National Cheng Kung University Hospital
  • Taoyuan Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Chicken extract supplement

Peptides supplement

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
Florbetaben (18F) PET Scan Imaging
Change from baseline values in Florbetaben (18F) PET scan

Secondary Outcome Measures

Handgrip strength
Change from baseline in handgrip strength
Ratio of plasma tau protein and amyloid-beta 42
Change from baseline in plasma tau protein & amyloid-beta 42 ratio
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.
Blood myeloperoxidase (MPO) levels
Change from baseline in blood myeloperoxidase (MPO) Higher levels of MPO indicate worse oxidative stress status
Blood inflammation biomarker levels (hs-CRP, ESR, TNF-α, 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 (TNFα) Interleukin 6 (IL-6)
Fasting blood glucose level
Change from baseline in fasting blood glucose level
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.
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.
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.
Incidence of infections
Number and incidence of infections occurring during the study period according to a self-reported infection survey
Cerebral blood flow measured with sonography
Mean values of cerebral blood flow measured with sonography
Blood pressure (systolic blood pressure and diastolic blood pressure)
Change from baseline in systolic and diastolic blood pressure

Full Information

First Posted
September 3, 2020
Last Updated
November 18, 2022
Sponsor
Brand's Suntory Asia
Collaborators
Taipei Medical University Shuang Ho Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04555655
Brief Title
The Effects of Chicken Extract and a Peptide Supplement for the Prevention of Cognitive Decline in Non-demented Elderly Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brand's Suntory Asia
Collaborators
Taipei Medical University Shuang Ho Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Mild Cognitive Impairment, Aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chicken extract supplement
Arm Type
Experimental
Arm Title
Peptides supplement
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Chicken extract supplement
Intervention Description
70ml of chicken extract supplement to be consumed daily in the morning before meals for 2 years.
Intervention Type
Dietary Supplement
Intervention Name(s)
Peptide Supplement
Intervention Description
70ml of Peptide Supplement (670mg) to be consumed daily in the morning before meals for 2 years.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
70ml of placebo (caesinate) to be consumed daily in the morning before meals for 2 years.
Primary Outcome Measure Information:
Title
Cognitive Function assessed by Alzheimer's Disease Composite Score (ADCOMS)
Description
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.
Time Frame
24 months
Title
Florbetaben (18F) PET Scan Imaging
Description
Change from baseline values in Florbetaben (18F) PET scan
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Handgrip strength
Description
Change from baseline in handgrip strength
Time Frame
12 months & 24 months
Title
Ratio of plasma tau protein and amyloid-beta 42
Description
Change from baseline in plasma tau protein & amyloid-beta 42 ratio
Time Frame
24 months
Title
Alzheimer's Disease Composite Score (ADCOMS)
Description
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.
Time Frame
12 months
Title
Blood myeloperoxidase (MPO) levels
Description
Change from baseline in blood myeloperoxidase (MPO) Higher levels of MPO indicate worse oxidative stress status
Time Frame
12 months & 24 months
Title
Blood inflammation biomarker levels (hs-CRP, ESR, TNF-α, IL-6)
Description
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 (TNFα) Interleukin 6 (IL-6)
Time Frame
12 months & 24 months
Title
Fasting blood glucose level
Description
Change from baseline in fasting blood glucose level
Time Frame
4, 8, 12, 18 and 24 months
Title
Taiwanese Depression Questionnaire (TQD) score
Description
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.
Time Frame
4, 8, 12, 18 and 24 months
Title
Short Form-36 (SF-36) Component and Scale Scores
Description
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.
Time Frame
4, 8, 12, 18 and 24 months
Title
Athens Insomnia Scale (AIS)
Description
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.
Time Frame
4, 8, 12, 18 and 24 months
Title
Incidence of infections
Description
Number and incidence of infections occurring during the study period according to a self-reported infection survey
Time Frame
24 months, reported at each study visit (4, 8, 12, 18 and 24 months)
Title
Cerebral blood flow measured with sonography
Description
Mean values of cerebral blood flow measured with sonography
Time Frame
12 months & 24 months
Title
Blood pressure (systolic blood pressure and diastolic blood pressure)
Description
Change from baseline in systolic and diastolic blood pressure
Time Frame
4, 8, 12, 18 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Taipei Medical University Hospital Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
235
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Taoyuan Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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