Trial Outcomes & Findings for Dietary Flavanols and Dentate Gyrus Function (NCT NCT02312310)
NCT ID: NCT02312310
Last Updated: 2020-06-11
Results Overview
The ModBent task is divided into two parts. During the matching trials (top), participants were shown a complex stimulus for 10 s. Following a 1-s inter-trial interval, they were required to select, via a key press, which of two stimuli matched the one they had just studied, as quickly and as accurately as possible. Following 41 matching trials, participants were shown a series of 82 stimuli (bottom), 41 of which appeared on the initial study set during the matching trials and 41 of which were foils. They were required to indicate, as quickly as possible, whether each stimulus appeared earlier (yes response) or was new (no response). The primary variable of the ModBent task is the mean RT for correct rejections of foils during the recognition trials
COMPLETED
NA
211 participants
baseline and 12 weeks
2020-06-11
Participant Flow
first consent; 1/13/2016 Final data collection session: 11/21/2018 All data collected at Columbia University Medical Center
1. consent: exclusions: 5 BMI too high; 66 MOCA too low; 4 elevated blood pressure; 16 other; 17 lost to follow-up 2. two week run-in period: exclusions: 24 failed, 17 withdrew or lost to follow-up 3. baseline assessments: exclusions: 1 lost to follow-up
Participant milestones
| Measure |
0 mg Cocoa Flavanol
daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
|
260 mg Cocoa Flavanol
daily consumption of capsules containing 260 mg cocoa flavanol for 12 weeks;
|
510 mg Cocoa Flavanol
daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks;
|
770 mg Cocoa Flavanol
daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks;
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
53
|
52
|
|
Overall Study
COMPLETED
|
51
|
51
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dietary Flavanols and Dentate Gyrus Function
Baseline characteristics by cohort
| Measure |
0 mg
n=53 Participants
daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
|
260 mg
n=53 Participants
daily consumption of capsules containing 260 mg cocoa flavanol for 12 weeks;
|
510 mg
n=53 Participants
daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks;
|
770 mg
n=52 Participants
daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks;
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.47 years
STANDARD_DEVIATION 6.78 • n=5 Participants
|
60.81 years
STANDARD_DEVIATION 6.71 • n=7 Participants
|
61 years
STANDARD_DEVIATION 6.15 • n=5 Participants
|
61.23 years
STANDARD_DEVIATION 6.37 • n=4 Participants
|
61.13 years
STANDARD_DEVIATION 6.47 • n=21 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
191 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
160 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
211 Participants
n=21 Participants
|
|
alternative Healthy Eating Index (aHEI)
|
65.09 units on a scale
STANDARD_DEVIATION 11.44 • n=5 Participants
|
68.78 units on a scale
STANDARD_DEVIATION 10.82 • n=7 Participants
|
64.83 units on a scale
STANDARD_DEVIATION 14.3 • n=5 Participants
|
66.74 units on a scale
STANDARD_DEVIATION 10.84 • n=4 Participants
|
66.36 units on a scale
STANDARD_DEVIATION 12 • n=21 Participants
|
|
5-(3',4'-dihydroxyphenyl)-γ-valerolactone (gVLM)
|
19.7 nM
STANDARD_DEVIATION 24.23 • n=5 Participants
|
20.98 nM
STANDARD_DEVIATION 34.28 • n=7 Participants
|
44.32 nM
STANDARD_DEVIATION 72.4 • n=5 Participants
|
36.59 nM
STANDARD_DEVIATION 72.06 • n=4 Participants
|
30.44 nM
STANDARD_DEVIATION 55.84 • n=21 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksThe ModBent task is divided into two parts. During the matching trials (top), participants were shown a complex stimulus for 10 s. Following a 1-s inter-trial interval, they were required to select, via a key press, which of two stimuli matched the one they had just studied, as quickly and as accurately as possible. Following 41 matching trials, participants were shown a series of 82 stimuli (bottom), 41 of which appeared on the initial study set during the matching trials and 41 of which were foils. They were required to indicate, as quickly as possible, whether each stimulus appeared earlier (yes response) or was new (no response). The primary variable of the ModBent task is the mean RT for correct rejections of foils during the recognition trials
Outcome measures
| Measure |
0 mg Cocoa Flavanol
n=51 Participants
daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
|
260 mg Cocoa Flavanol
n=51 Participants
daily consumption of capsules containing 260 mg cocoa flavanol for 12 weeks;
|
510 mg Cocoa Flavanol
n=50 Participants
daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks;
|
770 mg Cocoa Flavanol
n=52 Participants
daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks;
|
|---|---|---|---|---|
|
Modified Benton Recognition Task (ModBent)
Baseline
|
2807.98 ms
Standard Deviation 1733.36
|
2579.94 ms
Standard Deviation 1026.18
|
2603.65 ms
Standard Deviation 999.31
|
2732.79 ms
Standard Deviation 1367.96
|
|
Modified Benton Recognition Task (ModBent)
12 Weeks
|
2671.50 ms
Standard Deviation 1431.17
|
2489.84 ms
Standard Deviation 1135.40
|
2381.68 ms
Standard Deviation 929.14
|
2653.01 ms
Standard Deviation 1289.18
|
SECONDARY outcome
Timeframe: baseline and 12 weeksmeasured in functional MRI. we generated high-resolution CBV brain maps using gadolinium-enhanced T1-weighted scans acquired perpendicular to the hippocampal long-axis, with sub-millimeter in-plane resolution of 0.68 × 0.68 mm and slice thickness of 3 mm. To perform group-wise voxel-based analyses on the whole hippocampal circuit, we first isolated hippocampal subfields using FreeSurfer segmentations and thresholded posterior probabilities to generate a composite mask of the bilateral hippocampal formation. These masked T1-weighted images were then used to generate a group-wise template to which individual images were co-registered using a diffeomorphic technique that maximizes cross-correlation among images.
Outcome measures
| Measure |
0 mg Cocoa Flavanol
n=14 Participants
daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
|
260 mg Cocoa Flavanol
n=10 Participants
daily consumption of capsules containing 260 mg cocoa flavanol for 12 weeks;
|
510 mg Cocoa Flavanol
n=13 Participants
daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks;
|
770 mg Cocoa Flavanol
n=12 Participants
daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks;
|
|---|---|---|---|---|
|
Dentate Gyrus Cerebral Blood Volume
Baseline
|
2.44 % cerebral blood volume
Standard Deviation .81
|
2.17 % cerebral blood volume
Standard Deviation .69
|
2.11 % cerebral blood volume
Standard Deviation 0.47
|
1.85 % cerebral blood volume
Standard Deviation 0.67
|
|
Dentate Gyrus Cerebral Blood Volume
12 Weeks
|
2.25 % cerebral blood volume
Standard Deviation .57
|
2.11 % cerebral blood volume
Standard Deviation .52
|
2.01 % cerebral blood volume
Standard Deviation .71
|
2.23 % cerebral blood volume
Standard Deviation .59
|
SECONDARY outcome
Timeframe: 20 weeksThe ModBent task is divided into two parts. During the matching trials (top), participants were shown a complex stimulus for 10 s. Following a 1-s inter-trial interval, they were required to select, via a key press, which of two stimuli matched the one they had just studied, as quickly and as accurately as possible. Following 41 matching trials, participants were shown a series of 82 stimuli (bottom), 41 of which appeared on the initial study set during the matching trials and 41 of which were foils. They were required to indicate, as quickly as possible, whether each stimulus appeared earlier (yes response) or was new (no response). The primary variable of the ModBent task is the mean RT for correct rejections of foils during the recognition trials
Outcome measures
| Measure |
0 mg Cocoa Flavanol
n=50 Participants
daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
|
260 mg Cocoa Flavanol
n=49 Participants
daily consumption of capsules containing 260 mg cocoa flavanol for 12 weeks;
|
510 mg Cocoa Flavanol
n=50 Participants
daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks;
|
770 mg Cocoa Flavanol
n=51 Participants
daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks;
|
|---|---|---|---|---|
|
Modified Benton Recognition Task (ModBent)
|
2542.76 ms
Standard Deviation 1278.87
|
2475.35 ms
Standard Deviation 1512.88
|
2373.78 ms
Standard Deviation 934.84
|
2550.18 ms
Standard Deviation 1165.92
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksIn learning Trials 1 to 3 the participant is read 20 unique, semantically/phonemically unrelated words (List A) and is to free recall those words after each trial. Next the participant is read a list of 20 unique words (List B) and is to recall as many as possible. This trial is followed by a short delay free recall trial: the participant is to recall as many words as possible from List A. After a 1.5-hour, the participant is asked to long delay free recall words from List A and then from List B. This is followed by a 66-item forced recognition trial: the participant is read a list of 66 words and asked to distinguish List A words from semantic and phonemic distractors, including words from List B. Finally, a source memory trial is administered: the examiner serially reads words from List A and B. The participant is to specify from which list each word came.Higher score indicates better performance. score ranges from 0 to 60.
Outcome measures
| Measure |
0 mg Cocoa Flavanol
n=51 Participants
daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
|
260 mg Cocoa Flavanol
n=51 Participants
daily consumption of capsules containing 260 mg cocoa flavanol for 12 weeks;
|
510 mg Cocoa Flavanol
n=50 Participants
daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks;
|
770 mg Cocoa Flavanol
n=52 Participants
daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks;
|
|---|---|---|---|---|
|
Modified Rey Auditory Verbal Learning Test
Baseline
|
38.91 units on a scale
Standard Deviation 8.45
|
37.25 units on a scale
Standard Deviation 8.19
|
39.75 units on a scale
Standard Deviation 7.38
|
39.96 units on a scale
Standard Deviation 9.62
|
|
Modified Rey Auditory Verbal Learning Test
12 Weeks
|
39.49 units on a scale
Standard Deviation 9.70
|
38.69 units on a scale
Standard Deviation 9.30
|
41.10 units on a scale
Standard Deviation 8.50
|
41.92 units on a scale
Standard Deviation 8.48
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksParticipants are presented with a series of stimuli, each of which is both visually and auditorily presented by computer. A picture of each stimulus is displayed on the computer monitor for 2 seconds while the name of the stimulus is simultaneously being read via a computerized voice; stimuli are presented one after another. The participant must remember each stimulus in a series, mentally reorder them from smallest to largest, and recite the names of the stimuli in this order. List Sorting scores are based upon Total Score. Higher score indicated better performance.Score ranges from 0-100.
Outcome measures
| Measure |
0 mg Cocoa Flavanol
n=51 Participants
daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
|
260 mg Cocoa Flavanol
n=51 Participants
daily consumption of capsules containing 260 mg cocoa flavanol for 12 weeks;
|
510 mg Cocoa Flavanol
n=50 Participants
daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks;
|
770 mg Cocoa Flavanol
n=52 Participants
daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks;
|
|---|---|---|---|---|
|
NIH Toolbox Cognition Battery (NIHTB-CB): The List Sorting Test
Baseline
|
52.89 units on a scale
Standard Deviation 8.85
|
56.81 units on a scale
Standard Deviation 8.91
|
54.60 units on a scale
Standard Deviation 9.15
|
55.18 units on a scale
Standard Deviation 8.65
|
|
NIH Toolbox Cognition Battery (NIHTB-CB): The List Sorting Test
12 Weeks
|
53.34 units on a scale
Standard Deviation 7.44
|
56.10 units on a scale
Standard Deviation 8.47
|
54.86 units on a scale
Standard Deviation 8.56
|
53.46 units on a scale
Standard Deviation 9.23
|
Adverse Events
0 mg Cocoa Flavanol
260 mg Cocoa Flavanol
510 mg Cocoa Flavanol
770 mg Cocoa Flavanol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place