- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06210035
Effects of Heart Rate Oscillations During Meditation on Plasma Biomarkers of Alzheimer's Disease
December 12, 2025 updated by: Mara Mather, University of Southern California
In the current study, we will examine how two types of concentration meditation practices affect plasma biomarkers of Alzheimer's Disease (AD).
We will also examine the effects of the two types of meditation practices on emotional well-being and episodic memory.
Healthy adults aged 18-35 who meet all eligibility criteria will be invited to this study.
Participants will be asked to engage in one week of daily meditation practice or no-intervention control task at home.
They will also be asked to visit the lab twice, once before and once after the intervention, to provide blood samples to assess plasma biomarkers of AD and to complete emotion questionnaires and a memory test.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90089
- University of Southern California
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Fluent in English
- Aged between 18-35 years old
- Agree to provide blood samples
- Healthy adults who weigh at least 110 pounds
- Agree to devote 40 minutes daily to this study for a week
Exclusion Criteria:
- Have a disorder that would affect heart rhythm or function (e.g., abnormal cardiac rhythm, dyspnea, heart disease including coronary artery disease, angina and arrhythmia)
- Regularly practicing any relaxation, meditation or yoga that involve breathing focused practices lasting for more than an hour each week
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Participants will engage in concentration meditation for 40 minutes every day for a week.
They will focus on the sensations around the belly.
|
|
Experimental: 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.
|
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: No-intervention control
Participants will rest quietly for 40 minutes every day for a week while recording heart rate.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Plasma Amyloid Beta (Aβ) Levels
Time Frame: Measured from blood draws before and after a one-week intervention
|
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.
|
Measured from blood draws before and after a one-week intervention
|
|
Change in Plasma Ab42/40 Ratio
Time Frame: Measured from blood draws before and after a one-week intervention
|
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).
|
Measured from blood draws before and after a one-week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Plasma pTau-181/Tau Ratio
Time Frame: Measured from blood draws before and after a one-week intervention
|
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).
|
Measured from blood draws before and after a one-week intervention
|
|
Change in Emotional Well-being
Time Frame: Measured before and after a one-week intervention
|
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.
|
Measured before and after a one-week intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Episodic Memory
Time Frame: Measured after a one-week intervention
|
The investigators will conduct a one-way ANOVA to assess group differences in episodic memory.
|
Measured after a one-week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2024
Primary Completion (Actual)
May 3, 2024
Study Completion (Actual)
May 3, 2024
Study Registration Dates
First Submitted
October 20, 2023
First Submitted That Met QC Criteria
January 5, 2024
First Posted (Actual)
January 18, 2024
Study Record Updates
Last Update Posted (Actual)
January 5, 2026
Last Update Submitted That Met QC Criteria
December 12, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP-23-00373
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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