HealthyNCT04470505
Optimizing Platelet Isolation (The Cell Study)
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The research study is about blood cells (platelets) and their power houses (mitochondria). The investigators want to learn about their behavior in order to ensure that our laboratory procedures are generating optimal results. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2020to 25 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 25-35 years old
Who may be able to join
- Age 25-35
- All races
- All ethnicity
- 18.5 - 30 BMI
Who cannot join
- smoking
- Aspirin intake
- Recreational drug use
- Alcohol intake more than 3 times per week
- Self-reported possibility of current pregnancy
- Known diagnosis of:
Show all 18Show fewer
- Pre-diabetes
- Diabetes
- High cholesterol
- High triglycerides
- Hypertension
- Anemia
- Autism spectrum disorder
- Attention deficit hyperactivity disorder (ADHD)
- Attention deficit disorder (ADD)
- Severe asthma
- Refusal to stop taking nutritional supplements
- Any other pre-existing medical condition that requires daily medication as determined by the investigators to affect outcome of interest
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: Optimizing Platelet Isolation for Measures of Human Platelet Mitochondrial Respiration (The Cell Study)
The research study is about blood cells (platelets) and their power houses (mitochondria). The investigators want to learn about their behavior in order to ensure that our laboratory procedures are generating optimal results.
Read the detailed description
The objectives of this study are to assess platelet activation following standard laboratory procedures used in the process of measuring platelet mitochondrial function, and to determine the optimal amount of digitonin needed to permeabilize platelet cell membrane.
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet activation from isolated platelets
Whole blood will be collected following an overnight fast, and platelets isolated using standard procedures. Platelet activation markers (e.g., CD62P ) will be measured using flow cytometric analysis.
Measured: day 1
Secondary outcomes (2)
Platelet activation measured in whole blood
Whole blood will be collected following an overnight fast. Platelet activation will be measured in whole blood by the expression CD62P
Measured: day 1
Platelet reactivity measured in whole blood
Whole blood will be collected following an overnight fast. Platelet reactivity will be measured in whole blood with adenosine diphosphate (ADP).
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start6 Jul 2020
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470505
- Sponsor's protocol ID
- 260236
- Status last verified
- Oct 2025
- First submitted
- 2 Jul 2020
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Platelet Isolation for Measures of Human Platelet Mitochondrial Respiration (The Cell Study)
- ClinicalTrials.gov ID
- NCT04470505
- Acronym / sponsor ID
- 260236
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research study is about blood cells (platelets) and their power houses (mitochondria). The investigators want to learn about their behavior in order to ensure that our laboratory procedures are generating optimal results.
Detailed description
The objectives of this study are to assess platelet activation following standard laboratory procedures used in the process of measuring platelet mitochondrial function, and to determine the optimal amount of digitonin needed to permeabilize platelet cell membrane.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 25-35 years old
Key inclusion criteria (4 listed)
- Age 25-35
- All races
- All ethnicity
- 18.5 - 30 BMI
Key exclusion criteria (18 listed)
- smoking
- Aspirin intake
- Recreational drug use
- Alcohol intake more than 3 times per week
- Self-reported possibility of current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet activation from isolated platelets
Time frame: day 1
Whole blood will be collected following an overnight fast, and platelets isolated using standard procedures. Platelet activation markers (e.g., CD62P ) will be measured using flow cytometric analysis.
2 secondary outcomes
Platelet activation measured in whole blood
Time frame: day 1
Platelet reactivity measured in whole blood
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet activation from isolated platelets (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.