Trial Outcomes & Findings for Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment (NCT NCT02414607)
NCT ID: NCT02414607
Last Updated: 2022-06-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
12 wks, 6 mos
Results posted on
2022-06-23
Participant Flow
Participant milestones
| Measure |
Elderberry Juice
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Elderberry Juice
|
Placebo
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
Baseline characteristics by cohort
| Measure |
Elderberry Juice
n=11 Participants
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Elderberry Juice
|
Placebo
n=13 Participants
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Placebo
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
76.45 years
STANDARD_DEVIATION 8.47 • n=5 Participants
|
76.23 years
STANDARD_DEVIATION 7.73 • n=7 Participants
|
76.33 years
STANDARD_DEVIATION 6.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 wks, 6 mosProblem 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.
Outcome measures
| Measure |
Elderberry Juice
n=11 Participants
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Elderberry Juice
|
Placebo
n=13 Participants
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Placebo
|
|---|---|---|
|
Visuospatial Problem Solving Battery (VSP)
12 week change from baseline
|
.30 Mean Difference Score (VPS Total Score)
Standard Error .52
|
.29 Mean Difference Score (VPS Total Score)
Standard Error .47
|
|
Visuospatial Problem Solving Battery (VSP)
6 month change from baseline
|
.097 Mean Difference Score (VPS Total Score)
Standard Error .44
|
.52 Mean Difference Score (VPS Total Score)
Standard Error .38
|
SECONDARY outcome
Timeframe: 12 wks, 6 mosAssesses 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.
Outcome measures
| Measure |
Elderberry Juice
n=11 Participants
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Elderberry Juice
|
Placebo
n=13 Participants
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Placebo
|
|---|---|---|
|
Clinical Dementia Rating (CDR) Scale
Change from Baseline at 12 weeks
|
0 Mean difference on CDR scale
Standard Error 0
|
0 Mean difference on CDR scale
Standard Error 0
|
|
Clinical Dementia Rating (CDR) Scale
Change from Baseline at 6 months
|
0 Mean difference on CDR scale
Standard Error 0
|
0 Mean difference on CDR scale
Standard Error 0
|
SECONDARY outcome
Timeframe: 12 wks, 6 mosScreening 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.
Outcome measures
| Measure |
Elderberry Juice
n=11 Participants
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Elderberry Juice
|
Placebo
n=13 Participants
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Placebo
|
|---|---|---|
|
Mini-Mental State Examination (MMSE)
Change from baseline at 12 weeks
|
.03 Mean Difference Score (MMSE)
Standard Error .73
|
.29 Mean Difference Score (MMSE)
Standard Error .66
|
|
Mini-Mental State Examination (MMSE)
Change from baseline at 6 months
|
-1.01 Mean Difference Score (MMSE)
Standard Error .90
|
.06 Mean Difference Score (MMSE)
Standard Error .82
|
SECONDARY outcome
Timeframe: 12 wks, 6 mosAssesses 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.
Outcome measures
| Measure |
Elderberry Juice
n=11 Participants
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Elderberry Juice
|
Placebo
n=13 Participants
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Placebo
|
|---|---|---|
|
Hopkins Verbal Learning Test (HVLT)
Change from baseline at 12 weeks
|
-.50 Mean Difference Score (HVL Free Recall)
Standard Error .43
|
.46 Mean Difference Score (HVL Free Recall)
Standard Error .40
|
|
Hopkins Verbal Learning Test (HVLT)
Change from baseline at 6 months
|
-19 Mean Difference Score (HVL Free Recall)
Standard Error .33
|
.27 Mean Difference Score (HVL Free Recall)
Standard Error .29
|
SECONDARY outcome
Timeframe: 12 wks, 6 mosMeasures word retrieval. Change in the BNT is the primary outcome measure. The range is 0-60 with higher representing better performance.
Outcome measures
| Measure |
Elderberry Juice
n=11 Participants
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Elderberry Juice
|
Placebo
n=13 Participants
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Placebo
|
|---|---|---|
|
Boston Naming Test (BNT)
Change from baseline at 12 weeks
|
1.38 Mean Difference Score (BNT Total)
Standard Error .65
|
.94 Mean Difference Score (BNT Total)
Standard Error .59
|
|
Boston Naming Test (BNT)
Change from baseline at 6 months
|
.96 Mean Difference Score (BNT Total)
Standard Error .54
|
1.60 Mean Difference Score (BNT Total)
Standard Error .49
|
SECONDARY outcome
Timeframe: 12 wks, 6 mosParticipants 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.
Outcome measures
| Measure |
Elderberry Juice
n=11 Participants
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Elderberry Juice
|
Placebo
n=12 Participants
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Placebo
|
|---|---|---|
|
Rey Complex Figure Task (Rey)
Change from baseline at 12 weeks
|
-1.03 Mean Difference Score (REY Copy Score)
Standard Error 1.43
|
1.41 Mean Difference Score (REY Copy Score)
Standard Error 1.35
|
|
Rey Complex Figure Task (Rey)
Change from baseline at 6 months
|
-.54 Mean Difference Score (REY Copy Score)
Standard Error 1.61
|
-1.72 Mean Difference Score (REY Copy Score)
Standard Error .27
|
SECONDARY outcome
Timeframe: 12 wks, 6 mosRearranging 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.
Outcome measures
| Measure |
Elderberry Juice
n=11 Participants
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Elderberry Juice
|
Placebo
n=12 Participants
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Placebo
|
|---|---|---|
|
Anagrams
Change from baseline at 12 weeks
|
-1.81 Mean Difference Score (Anagrams Total)
Standard Error .13
|
2.70 Mean Difference Score (Anagrams Total)
Standard Error .99
|
|
Anagrams
Change from baseline at 6 months
|
-.41 Mean Difference Score (Anagrams Total)
Standard Error .95
|
1.67 Mean Difference Score (Anagrams Total)
Standard Error .86
|
SECONDARY outcome
Timeframe: 12 wks, 6 mosAssesses 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.
Outcome measures
| Measure |
Elderberry Juice
n=11 Participants
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Elderberry Juice
|
Placebo
n=12 Participants
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Placebo
|
|---|---|---|
|
Instrumental Activities of Daily Living Scale (IADLS)
Change from baseline at 12 weeks
|
.40 Mean Difference Score (IADL)
Standard Error .69
|
-.34 Mean Difference Score (IADL)
Standard Error .59
|
|
Instrumental Activities of Daily Living Scale (IADLS)
Change from baseline at 6 months
|
-30 Mean Difference Score (IADL)
Standard Error .66
|
-44 Mean Difference Score (IADL)
Standard Error .60
|
Adverse Events
Elderberry Juice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Elderberry Juice
n=11 participants at risk
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Elderberry Juice
|
Placebo
n=13 participants at risk
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Placebo
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Non-serious adverse event
|
0.00%
0/11 • 6 months
Serious adverse events or adverse events were documented.
|
7.7%
1/13 • Number of events 1 • 6 months
Serious adverse events or adverse events were documented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place