Trial Outcomes & Findings for Effects of Heart Rate Oscillations During Meditation on Plasma Biomarkers of Alzheimer's Disease (NCT NCT06210035)
NCT ID: NCT06210035
Last Updated: 2026-01-05
Results Overview
The investigators computed an aggregate Z-score based on plasma Aβ40 and Aβ42 levels (pg/mL). A Z-score of 0 represents the sample mean. Higher values indicate a greater level of plasma Aβ, which in cognitively normal individuals has been found to be associated with a higher risk of converting to Alzheimer's disease (Song et al., 2011). They conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for a time × condition interaction in plasma Aβ levels, assessing group differences in change over time.
COMPLETED
NA
94 participants
Measured from blood draws before and after a one-week intervention
2026-01-05
Participant Flow
Out of the 94 participants enrolled, 2 dropped before condition assignment.
Participant milestones
| Measure |
Belly-focus Concentration Meditation
Participants will engage in concentration meditation for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly.
Belly-focus meditation: Participants will engage in concentration meditation for 40 minutes every day for a week. They will focus on the sensations around the belly.
|
Belly-focus Concentration Meditation With Slow Breathing
Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly while breathing slowly.
Belly-focus meditation with slow breathing: Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week. They will focus on the sensations around the belly while breathing slowly.
|
No-intervention Control
Participants will rest quietly for 40 minutes every day for a week while recording heart rate.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
32
|
30
|
|
Overall Study
COMPLETED
|
27
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Belly-focus Concentration Meditation
Participants will engage in concentration meditation for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly.
Belly-focus meditation: Participants will engage in concentration meditation for 40 minutes every day for a week. They will focus on the sensations around the belly.
|
Belly-focus Concentration Meditation With Slow Breathing
Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly while breathing slowly.
Belly-focus meditation with slow breathing: Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week. They will focus on the sensations around the belly while breathing slowly.
|
No-intervention Control
Participants will rest quietly for 40 minutes every day for a week while recording heart rate.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
0
|
Baseline Characteristics
Effects of Heart Rate Oscillations During Meditation on Plasma Biomarkers of Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Belly-focus Concentration Meditation
n=30 Participants
Participants will engage in concentration meditation for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly.
Belly-focus meditation: Participants will engage in concentration meditation for 40 minutes every day for a week. They will focus on the sensations around the belly.
|
Belly-focus Concentration Meditation With Slow Breathing
n=32 Participants
Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly while breathing slowly.
Belly-focus meditation with slow breathing: Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week. They will focus on the sensations around the belly while breathing slowly.
|
No-intervention Control
n=30 Participants
Participants will rest quietly for 40 minutes every day for a week while recording heart rate.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=9667 Participants
|
32 Participants
n=6597 Participants
|
30 Participants
n=16264 Participants
|
92 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
25.07 years
STANDARD_DEVIATION 5.16 • n=9667 Participants
|
26.25 years
STANDARD_DEVIATION 5.29 • n=6597 Participants
|
26.20 years
STANDARD_DEVIATION 4.82 • n=16264 Participants
|
25.73 years
STANDARD_DEVIATION 5.05 • n=31 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=9667 Participants
|
26 Participants
n=6597 Participants
|
25 Participants
n=16264 Participants
|
75 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9667 Participants
|
6 Participants
n=6597 Participants
|
5 Participants
n=16264 Participants
|
17 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=9667 Participants
|
13 Participants
n=6597 Participants
|
8 Participants
n=16264 Participants
|
24 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=9667 Participants
|
18 Participants
n=6597 Participants
|
22 Participants
n=16264 Participants
|
65 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=9667 Participants
|
9 Participants
n=6597 Participants
|
10 Participants
n=16264 Participants
|
32 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=9667 Participants
|
3 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=9667 Participants
|
8 Participants
n=6597 Participants
|
10 Participants
n=16264 Participants
|
27 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9667 Participants
|
3 Participants
n=6597 Participants
|
4 Participants
n=16264 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9667 Participants
|
8 Participants
n=6597 Participants
|
6 Participants
n=16264 Participants
|
14 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=9667 Participants
|
32 participants
n=6597 Participants
|
30 participants
n=16264 Participants
|
92 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Measured from blood draws before and after a one-week interventionPopulation: Population analyzed is composed by all randomization subjects who completed pre- and post-intervention blood draw and whose data quality was sufficient for data analysis.
The investigators computed an aggregate Z-score based on plasma Aβ40 and Aβ42 levels (pg/mL). A Z-score of 0 represents the sample mean. Higher values indicate a greater level of plasma Aβ, which in cognitively normal individuals has been found to be associated with a higher risk of converting to Alzheimer's disease (Song et al., 2011). They conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for a time × condition interaction in plasma Aβ levels, assessing group differences in change over time.
Outcome measures
| Measure |
Belly-focus concentration meditation
n=24 Participants
Participants will engage in concentration meditation for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly.
Belly-focus meditation: Participants will engage in concentration meditation for 40 minutes every day for a week. They will focus on the sensations around the belly.
|
Belly-focus concentration meditation with slow breathing
n=28 Participants
Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly while breathing slowly.
Belly-focus meditation with slow breathing: Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week. They will focus on the sensations around the belly while breathing slowly.
|
No-intervention control
n=26 Participants
Participants will rest quietly for 40 minutes every day for a week while recording heart rate.
|
|---|---|---|---|
|
Change in Plasma Amyloid Beta (Aβ) Levels
pre
|
-0.38 Z-score
Standard Error 0.19
|
0.02 Z-score
Standard Error 0.17
|
0.24 Z-score
Standard Error 0.18
|
|
Change in Plasma Amyloid Beta (Aβ) Levels
post
|
-0.08 Z-score
Standard Error 0.17
|
-0.29 Z-score
Standard Error 0.16
|
0.22 Z-score
Standard Error 0.16
|
PRIMARY outcome
Timeframe: Measured from blood draws before and after a one-week interventionPopulation: Population analyzed is composed by all randomization subjects who completed pre- and post-intervention blood draw and whose data quality was sufficient for data analysis.
The investigators conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for an interaction effect on plasma Ab42/40 ratios. The plasma Ab42/40 ratio was calculated by dividing the plasma Ab42 concentration (pg/ml) by the plasma Ab40 concentration (pg/ml). A higher plasma Ab42/40 ratio indicates better outcome (i.e., greater brain clearance).
Outcome measures
| Measure |
Belly-focus concentration meditation
n=22 Participants
Participants will engage in concentration meditation for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly.
Belly-focus meditation: Participants will engage in concentration meditation for 40 minutes every day for a week. They will focus on the sensations around the belly.
|
Belly-focus concentration meditation with slow breathing
n=28 Participants
Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly while breathing slowly.
Belly-focus meditation with slow breathing: Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week. They will focus on the sensations around the belly while breathing slowly.
|
No-intervention control
n=25 Participants
Participants will rest quietly for 40 minutes every day for a week while recording heart rate.
|
|---|---|---|---|
|
Change in Plasma Ab42/40 Ratio
pre
|
0.05 ratio of Aβ42 to Aβ40
Standard Error 0.002
|
0.05 ratio of Aβ42 to Aβ40
Standard Error 0.001
|
0.05 ratio of Aβ42 to Aβ40
Standard Error 0.001
|
|
Change in Plasma Ab42/40 Ratio
post
|
0.05 ratio of Aβ42 to Aβ40
Standard Error 0.002
|
0.05 ratio of Aβ42 to Aβ40
Standard Error 0.001
|
0.05 ratio of Aβ42 to Aβ40
Standard Error 0.002
|
SECONDARY outcome
Timeframe: Measured from blood draws before and after a one-week interventionPopulation: Population analyzed is composed by all randomization subjects who completed pre- and post-intervention blood draw and whose data quality was sufficient for data analysis.
The investigators conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for an interaction effect on plasma pTau-181/total Tau ratios. The plasma pTau-181/total Tau ratio was calculated by dividing the plasma pTau-181 concentration (pg/ml) by the plasma total Tau concentration (pg/ml). A higher plasma pTau-181/total Tau ratio indicates better outcome (i.e., greater brain clearance).
Outcome measures
| Measure |
Belly-focus concentration meditation
n=23 Participants
Participants will engage in concentration meditation for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly.
Belly-focus meditation: Participants will engage in concentration meditation for 40 minutes every day for a week. They will focus on the sensations around the belly.
|
Belly-focus concentration meditation with slow breathing
n=25 Participants
Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly while breathing slowly.
Belly-focus meditation with slow breathing: Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week. They will focus on the sensations around the belly while breathing slowly.
|
No-intervention control
n=23 Participants
Participants will rest quietly for 40 minutes every day for a week while recording heart rate.
|
|---|---|---|---|
|
Change in Plasma pTau-181/Tau Ratio
pre
|
5.30 ratio of pTau-181 to total Tau
Standard Error 0.38
|
4.78 ratio of pTau-181 to total Tau
Standard Error 0.37
|
5.02 ratio of pTau-181 to total Tau
Standard Error 0.38
|
|
Change in Plasma pTau-181/Tau Ratio
post
|
4.73 ratio of pTau-181 to total Tau
Standard Error 0.37
|
5.29 ratio of pTau-181 to total Tau
Standard Error 0.36
|
4.64 ratio of pTau-181 to total Tau
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Measured before and after a one-week interventionPopulation: Population analyzed is composed by all randomization subjects who completed the emotional well-being survey (i.e., POMS) at pre- and post-intervention and whose data quality was sufficient for data analysis.
The investigators conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for an interaction effect on emotional well-being. Emotional well-being was assessed using the Profile of Mood States (POMS), which consists of 40 items rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total Mood Disturbance (TMD) scores were calculated by summing the negative mood items and subtracting the sum of the positive mood items. A constant of 100 was added to the TMD score to eliminate negative values. Higher scores indicate more negative mood states, with possible scores ranging from 56 to 216.
Outcome measures
| Measure |
Belly-focus concentration meditation
n=27 Participants
Participants will engage in concentration meditation for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly.
Belly-focus meditation: Participants will engage in concentration meditation for 40 minutes every day for a week. They will focus on the sensations around the belly.
|
Belly-focus concentration meditation with slow breathing
n=31 Participants
Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly while breathing slowly.
Belly-focus meditation with slow breathing: Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week. They will focus on the sensations around the belly while breathing slowly.
|
No-intervention control
n=26 Participants
Participants will rest quietly for 40 minutes every day for a week while recording heart rate.
|
|---|---|---|---|
|
Change in Emotional Well-being
pre
|
87.15 score on a scale
Standard Error 2.29
|
87.39 score on a scale
Standard Error 2.14
|
94.73 score on a scale
Standard Error 2.34
|
|
Change in Emotional Well-being
post
|
89.89 score on a scale
Standard Error 2.93
|
84.68 score on a scale
Standard Error 2.73
|
94.96 score on a scale
Standard Error 2.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured after a one-week interventionThe investigators will conduct a one-way ANOVA to assess group differences in episodic memory.
Outcome measures
Outcome data not reported
Adverse Events
Belly-focus Concentration Meditation
Belly-focus Concentration Meditation With Slow Breathing
No-intervention Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Belly-focus Concentration Meditation
n=30 participants at risk
Participants will engage in concentration meditation for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly.
Belly-focus meditation: Participants will engage in concentration meditation for 40 minutes every day for a week. They will focus on the sensations around the belly.
|
Belly-focus Concentration Meditation With Slow Breathing
n=32 participants at risk
Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly while breathing slowly.
Belly-focus meditation with slow breathing: Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week. They will focus on the sensations around the belly while breathing slowly.
|
No-intervention Control
n=30 participants at risk
Participants will rest quietly for 40 minutes every day for a week while recording heart rate.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Adverse events after blood draw
|
10.0%
3/30 • One week
|
0.00%
0/32 • One week
|
0.00%
0/30 • One week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place