Back to resultsEffect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Elderberry Juice
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Elderberry juice, Alzheimer's, Inflammation
Eligibility Criteria
Inclusion Criteria:
- CDR score of 0.5
- MMSE of at least 24
- Age 50 or older
Exclusion Criteria:
- Known history of sensitivity to elderberry products.
- Diabetes.
- Bleeding disorder.
- Current Pregnancy.
- Known allergy to honeysuckle.
- Currently making changes to other drugs that might affect cognitive performance (subjects showing the greatest cognitive decline and other signs of Alzheimer's disease may be prescribed cholinesterase inhibitors as this is a standard of care for Alzheimer's disease but not MCI).
- Presence of any condition the health professional believes will impair ability to complete study procedures (ex. terminal illness, comorbid major psychiatric disorders such as schizophrenia, or drug abuse).
- Potentially confounding neurodegenerative diseases (e.g. MS).
Sites / Locations
- University of Missouri Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Elderberry Juice
Placebo
Arm Description
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Outcomes
Primary Outcome Measures
Visuospatial Problem Solving Battery (VSP)
Problem solving task for detecting non-memory impairments in MCI. Change in score is the outcome measure. The task is a timed task, with the outcome measured in seconds. Each item was allowed 240 seconds for solution, with times averaged for items. Therefore, there was a range of 0-240 with lower being better.
Secondary Outcome Measures
Clinical Dementia Rating (CDR) Scale
Assesses memory, orientation, judgement and problem solving, community affairs, home/hobbies, personal care. Change in CDR was the outcome. CDR ranges from 0 to 3, with 3 being worse.
Mini-Mental State Examination (MMSE)
Screening for cognitive impairment sampling functions including arithmetic, memory and orientation. Change in MMSE was the outcome. the MMSE is a scale from 0 to 30 with a higher score being better.
Hopkins Verbal Learning Test (HVLT)
Assesses verbal learning and memory. Change in the HVLT was the outcome measure. The range for the HVLT is 0-36 with higher representing better memory.
Boston Naming Test (BNT)
Measures word retrieval. Change in the BNT is the primary outcome measure. The range is 0-60 with higher representing better performance.
Rey Complex Figure Task (Rey)
Participants reproduce complicated line drawings. Change in the Rey was the primary outcome measure. The range of the Rey is 0-36 with a higher score being better performance.
Anagrams
Rearranging letters to form words. Change in performance is the primary outcome measure. The task is timed, with each anagram allowed 120 seconds, so each word has a range of 0-120 seconds, and the average for the latency was calculated, for a range of 0-120 with lower numbers being better.
Instrumental Activities of Daily Living Scale (IADLS)
Assesses daily self-care activities. Change in the IADLS is the primary outcome. Total items were added together for this use of the task, so the range was from 0 to 23, with higher being better.
Full Information
NCT ID
NCT02414607
First Posted
March 20, 2015
Last Updated
May 27, 2022
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02414607
Brief Title
Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
Official Title
Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Elderberries (Sambuci fructus) have been shown in a number of studies to have significant anti-inflammatory and antioxidant effects. Multiple human and animal studies have supported the anti-inflammatory and antioxidant effects of elderberry preparations and it has been used in natural medicine for hundreds of years. Studies examining factors that may decrease the risk of Alzheimer's disease have revealed that drinking juices with similar properties to elderberries is one of the most reliable way to decrease risk. As such the investigators wish to determine the effects of elderberry juice on cognitive decline in a group of subjects at high risk for Alzheimer's disease, those with mild cognitive impairment. Elderberry juice is a commercially available nutritional supplement and easily available to this population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Elderberry juice, Alzheimer's, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elderberry Juice
Arm Type
Experimental
Arm Description
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Intervention Type
Biological
Intervention Name(s)
Elderberry Juice
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Visuospatial Problem Solving Battery (VSP)
Description
Problem solving task for detecting non-memory impairments in MCI. Change in score is the outcome measure. The task is a timed task, with the outcome measured in seconds. Each item was allowed 240 seconds for solution, with times averaged for items. Therefore, there was a range of 0-240 with lower being better.
Time Frame
12 wks, 6 mos
Secondary Outcome Measure Information:
Title
Clinical Dementia Rating (CDR) Scale
Description
Assesses memory, orientation, judgement and problem solving, community affairs, home/hobbies, personal care. Change in CDR was the outcome. CDR ranges from 0 to 3, with 3 being worse.
Time Frame
12 wks, 6 mos
Title
Mini-Mental State Examination (MMSE)
Description
Screening for cognitive impairment sampling functions including arithmetic, memory and orientation. Change in MMSE was the outcome. the MMSE is a scale from 0 to 30 with a higher score being better.
Time Frame
12 wks, 6 mos
Title
Hopkins Verbal Learning Test (HVLT)
Description
Assesses verbal learning and memory. Change in the HVLT was the outcome measure. The range for the HVLT is 0-36 with higher representing better memory.
Time Frame
12 wks, 6 mos
Title
Boston Naming Test (BNT)
Description
Measures word retrieval. Change in the BNT is the primary outcome measure. The range is 0-60 with higher representing better performance.
Time Frame
12 wks, 6 mos
Title
Rey Complex Figure Task (Rey)
Description
Participants reproduce complicated line drawings. Change in the Rey was the primary outcome measure. The range of the Rey is 0-36 with a higher score being better performance.
Time Frame
12 wks, 6 mos
Title
Anagrams
Description
Rearranging letters to form words. Change in performance is the primary outcome measure. The task is timed, with each anagram allowed 120 seconds, so each word has a range of 0-120 seconds, and the average for the latency was calculated, for a range of 0-120 with lower numbers being better.
Time Frame
12 wks, 6 mos
Title
Instrumental Activities of Daily Living Scale (IADLS)
Description
Assesses daily self-care activities. Change in the IADLS is the primary outcome. Total items were added together for this use of the task, so the range was from 0 to 23, with higher being better.
Time Frame
12 wks, 6 mos
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CDR score of 0.5
MMSE of at least 24
Age 50 or older
Exclusion Criteria:
Known history of sensitivity to elderberry products.
Diabetes.
Bleeding disorder.
Current Pregnancy.
Known allergy to honeysuckle.
Currently making changes to other drugs that might affect cognitive performance (subjects showing the greatest cognitive decline and other signs of Alzheimer's disease may be prescribed cholinesterase inhibitors as this is a standard of care for Alzheimer's disease but not MCI).
Presence of any condition the health professional believes will impair ability to complete study procedures (ex. terminal illness, comorbid major psychiatric disorders such as schizophrenia, or drug abuse).
Potentially confounding neurodegenerative diseases (e.g. MS).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Q Beversdorf, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Hospital
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
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Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
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