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

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: Mild Cognitive Impairment
• Intervention / Treatment: Other: Placebo; Biological: Elderberry Juice

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 wks, 6 mos

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 wks, 6 mos
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.	12 wks, 6 mos
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.	12 wks, 6 mos
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.	12 wks, 6 mos
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.	12 wks, 6 mos
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.	12 wks, 6 mos
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.	12 wks, 6 mos

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: David Q Beversdorf, MD, University of Missouri-Columbia

Study record dates

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: Inflammation; Alzheimer's; Elderberry juice
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Cognition Disorders; Inflammation; Cognitive Dysfunction
• Other Study ID Numbers: 1211953