- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02414607
Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
May 27, 2022 updated by: David Beversdorf, University of Missouri-Columbia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
48 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Elderberry Juice
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
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|
Placebo Comparator: Placebo
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visuospatial Problem Solving Battery (VSP)
Time Frame: 12 wks, 6 mos
|
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.
|
12 wks, 6 mos
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Dementia Rating (CDR) Scale
Time Frame: 12 wks, 6 mos
|
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.
|
12 wks, 6 mos
|
Mini-Mental State Examination (MMSE)
Time Frame: 12 wks, 6 mos
|
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.
|
12 wks, 6 mos
|
Hopkins Verbal Learning Test (HVLT)
Time Frame: 12 wks, 6 mos
|
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.
|
12 wks, 6 mos
|
Boston Naming Test (BNT)
Time Frame: 12 wks, 6 mos
|
Measures word retrieval.
Change in the BNT is the primary outcome measure.
The range is 0-60 with higher representing better performance.
|
12 wks, 6 mos
|
Rey Complex Figure Task (Rey)
Time Frame: 12 wks, 6 mos
|
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.
|
12 wks, 6 mos
|
Anagrams
Time Frame: 12 wks, 6 mos
|
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.
|
12 wks, 6 mos
|
Instrumental Activities of Daily Living Scale (IADLS)
Time Frame: 12 wks, 6 mos
|
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.
|
12 wks, 6 mos
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Q Beversdorf, MD, University of Missouri-Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
March 20, 2015
First Submitted That Met QC Criteria
April 10, 2015
First Posted (Estimate)
April 13, 2015
Study Record Updates
Last Update Posted (Actual)
June 23, 2022
Last Update Submitted That Met QC Criteria
May 27, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1211953
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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