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Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02414607
Recruitment Status : Completed
First Posted : April 13, 2015
Results First Posted : June 23, 2022
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
David Beversdorf, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Biological: Elderberry Juice Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
Study Start Date : September 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.
Biological: Elderberry Juice
Placebo Comparator: Placebo
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Other: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414607


Locations
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United States, Missouri
University of Missouri Hospital
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: David Q Beversdorf, MD University of Missouri-Columbia
  Study Documents (Full-Text)

Documents provided by David Beversdorf, University of Missouri-Columbia:
Study Protocol  [PDF] May 11, 2016
Statistical Analysis Plan  [PDF] April 28, 2020

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Responsible Party: David Beversdorf, Associate Professor: Radiology, Neurology, Psychology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02414607    
Other Study ID Numbers: 1211953
First Posted: April 13, 2015    Key Record Dates
Results First Posted: June 23, 2022
Last Update Posted: June 23, 2022
Last Verified: May 2022
Keywords provided by David Beversdorf, University of Missouri-Columbia:
Elderberry juice
Alzheimer's
Inflammation
Additional relevant MeSH terms:
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Inflammation
Cognitive Dysfunction
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders