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

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

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

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

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.

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

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.

Clinical Trials on Mild Cognitive Impairment

Clinical Trials on Placebo

3
Subscribe