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

University of Missouri (MU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Mild Cognitive Impairment

Treatments: Other: Placebo; Biological: Elderberry Juice

Study type: Interventional

Funder types: Other

Identifiers

NCT02414607

1211953

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Elderberry Juice

Experimental group

Description:

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

Treatment:

Biological: Elderberry Juice

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo