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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414607
• Other study ID #: 1211953
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2016
• Est. completion date: December 2019

Study information

• Verified date: May 2022
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Inflammation
• Mild Cognitive Impairment

Intervention

Biological:
• Elderberry Juice

Other:
• Placebo

Locations

Country	Name	City	State
United States	University of Missouri Hospital	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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