Optimizing Platelet Isolation (The Cell Study)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Nutrition Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

25-35 years old

Description

Inclusion Criteria:

• Age 25-35
• All races
• All ethnicity
• 18.5 - 30 BMI

Exclusion Criteria:

• smoking
• Aspirin intake
• Recreational drug use
• Alcohol intake more than 3 times per week
• Self-reported possibility of current pregnancy
• Known diagnosis of:
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	day 1

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): September 1, 2023
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 260236

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No