Lipids and Energy Study: Optimizing the Analysis of Lipids and Energy Metabolism in Blood Samples

Sponsor

Ohio State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04981288

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The proposed research is a feasibility pilot trial designed to optimize the remote collection dried blood spots (DBS) from a finger stick and the analysis of fatty acid from the DBS and to optimize the analysis of mitochondria activity (or energy metabolism) from peripheral blood mononuclear cells (PBMC) or white blood cell samples. Participants in this study will provide a blood sample from venous blood draw and finger sticks. One finger stick collection will be completed remotely using a DBS kit that is sent through the mail while the other finger stick collection will be completed at the research site. These samples will be use to optimize the method for measuring fatty acids and mitochondria function as well as measure other lipids, insulin, glucose and markers of inflammation using established protocols. Demographic, dietary, sleep, and physical activity information will be measured using questionnaires, while height and weight will be measured to calculate body mass index (BMI).

Condition or Disease	Intervention/Treatment	Phase
Healthy

Detailed Description

The primary objectives of the study are

To optimize remote blood collection and laboratory analysis of polyunsaturated fatty acids (PUFAs) in dried blood spot (DBS) samples
To optimize the analysis of mitochondria function in fresh and frozen peripheral blood mononuclear cells (PBMC)

Study Design

Study Type:

Observational

Anticipated Enrollment :

24 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Lipids and Energy Study: Optimizing the Analysis of Lipids and Energy Metabolism in Blood Samples

Actual Study Start Date :

Jul 2, 2021

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2025

Outcome Measures

Primary Outcome Measures

Optimize mitochondria function measurements in fresh and frozen blood [1 Day]
Measuring oxygen consumption rate in peripheral blood mononuclear cells using seahorse analyzer
Optimize remote blood collection and laboratory analysis of in dried blood spot samples [2 Days]
Collecting dried blot spots remotely and in the research setting and venous blood draw in the research setting to compare fatty acid composition

Secondary Outcome Measures

Assess the relationship of mitochondria function in and cardiolipin in peripheral blood mononuclear cells [1 Day]
Determine mitochondria function in peripheral blood mononuclear cells by measuring oxygen consumption rate and determining its relationship to the mitochondrial phospholipid cardiolipin
Assess the relationship of mitochondria function and fatty acid metabolites [1 Day]
Determine mitochondria function in peripheral blood mononuclear cells by measuring oxygen consumption rate and determining its relationship to the fatty acid metabolites in plasma
Assess the relationship of mitochondria function and markers of inflammation [1 Day]
Determine mitochondria function in peripheral blood mononuclear cells by measuring oxygen consumption rate and determining its relationship to markers of inflammation in plasma
Assess the relationship of mitochondria function in peripheral blood mononuclear cells and markers of glycemia [1 Day]
Determine mitochondria function in peripheral blood mononuclear cells by measuring oxygen consumption rate and determining its relationship to markers of glycemia in serum

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18 years of age or older
Nonsmoking

Exclusion Criteria:

Diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Human Nutrition Laboratory	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Martha Belury, Associate Professor, Ohio State University

ClinicalTrials.gov Identifier:

NCT04981288

Other Study ID Numbers:

2021H0184

First Posted:

Jul 28, 2021

Last Update Posted:

Sep 10, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 10, 2021