Healthy Clinical Trial
Official title:
Lipids and Energy Study: Optimizing the Analysis of Lipids and Energy Metabolism in Blood Samples
| Verified date | April 2024 |
| Source | Ohio State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Active, not recruiting |
| Enrollment | 24 |
| Est. completion date | August 1, 2025 |
| Est. primary completion date | August 1, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 18 years of age or older - Nonsmoking Exclusion Criteria: - Diabetes |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Ohio State University Human Nutrition Laboratory | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ohio State University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Optimize mitochondria function measurements in fresh and frozen blood | Measuring oxygen consumption rate in peripheral blood mononuclear cells using seahorse analyzer | 1 Day | |
| Primary | Optimize remote blood collection and laboratory analysis of in dried blood spot samples | Collecting dried blot spots remotely and in the research setting and venous blood draw in the research setting to compare fatty acid composition | 2 Days | |
| Secondary | Assess the relationship of mitochondria function in and cardiolipin in peripheral blood mononuclear cells | Determine mitochondria function in peripheral blood mononuclear cells by measuring oxygen consumption rate and determining its relationship to the mitochondrial phospholipid cardiolipin | 1 Day | |
| Secondary | Assess the relationship of mitochondria function and fatty acid metabolites | Determine mitochondria function in peripheral blood mononuclear cells by measuring oxygen consumption rate and determining its relationship to the fatty acid metabolites in plasma | 1 Day | |
| Secondary | Assess the relationship of mitochondria function and markers of inflammation | Determine mitochondria function in peripheral blood mononuclear cells by measuring oxygen consumption rate and determining its relationship to markers of inflammation in plasma | 1 Day | |
| Secondary | Assess the relationship of mitochondria function in peripheral blood mononuclear cells and markers of glycemia | Determine mitochondria function in peripheral blood mononuclear cells by measuring oxygen consumption rate and determining its relationship to markers of glycemia in serum | 1 Day |
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