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

NCT ID: NCT02414607

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-12-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Elderberry Juice

Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.

Group Type: EXPERIMENTAL

Elderberry Juice

Intervention Type: BIOLOGICAL

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Elderberry Juice

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

David Beversdorf

Associate Professor: Radiology, Neurology, Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Q Beversdorf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri Hospital

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1211953

Identifier Type: -

Identifier Source: org_study_id