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Completed

NCT Number: NCT06491979

Vitamin and Unsaturated Fatty Acid Supplements in Healthy and Uveitis Human Subjects

The goal of this clinical trial is to learn if dietary supplements containing vitamin and unsaturated fatty acid works to intervene T cell inflammatory factor expression in patients with uveitis and healthy subjects in adults.

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Key information

Conditions

Healthy Autoimmune Diseases Eye Diseases Immune System Diseases Uveal Diseases Uveitis

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300071, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy or with uveitis volunteers age 19-65 years.

Exclusion criteria

  • abnormal blood glucose, blood pressure, blood lipids, or other systemic diseases should not participate in the study

Treatment and study plan

Vitamin A treatment

Dietary Supplement

Vitamin A, 32 microgram per kilograms (of body weight) per day, for three weeks

Monounsaturated fatty acid mixture

Dietary Supplement

Monounsaturated fatty acid mixture (mainly Omega-7, Omega-9), 47 milligrams per kilogram (of body weight) per day, for three weeks

Polyunsaturated fatty acid mixture

Dietary Supplement

Polyunsaturated fatty acid mixture (mainly Omega-3, Omega-6), 6 milligrams per kilogram (of body weight) per day, for three weeks

Fatty acid mixture

Dietary Supplement

Fatty acid mixture (mainly saturated fatty acid, Omega-6, Omega-7, Omega-9), 83 milligrams per kilogram (of body weight) per day, for three weeks

Primary outcomes

  1. Inflammatory factors-Interleukin-17A (IL-17A)

    Time frame: 3 weeks

    Flow cytometry analysis of peripheral blood mononuclear cells (PBMCs) to detect the ratio of Interleukin-17A (IL-17A) -producing cells in CD4+ T cells and CD8+ T cells

  2. Inflammatory factors-Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)

    Time frame: 3 weeks

    Flow cytometry analysis of peripheral blood mononuclear cells (PBMCs) to detect the ratio of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) -producing cells in CD4+ T cells and CD8+ T cells

  3. Inflammatory factors-Interferon gamma (IFN-γ)

    Time frame: 3 weeks

    Flow cytometry analysis of peripheral blood mononuclear cells (PBMCs) to detect the ratio of Interferon gamma (IFN-γ) -producing cells in CD4+ T cells and CD8+ T cells

Secondary outcomes

  1. Cytokine levels-Interleukin-17A (IL-17A)

    Time frame: 3 weeks

    Analysis of cytokine levels in blood. Detect the concention of Interleukin-17A (IL-17A) in plasma

  2. Cytokine levels-Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)

    Time frame: 3 weeks

    Analysis of cytokine levels in blood. Detect the concention of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in plasma

  3. Cytokine levels-Interferon gamma (IFN-γ)

    Time frame: 3 weeks

    Analysis of cytokine levels in blood. Detect the concention of Interferon gamma (IFN-γ) in plasma

  4. Cytokine levels-Interleukin-2 (IL-2)

    Time frame: 3 weeks

    Analysis of cytokine levels in blood. Detect the concention of Interleukin-2 (IL-2) in plasma

  5. Cytokine levels-Interleukin-10 (IL-10)

    Time frame: 3 weeks

    Analysis of cytokine levels in blood. Detect the concention of Interleukin-10 (IL-10) in plasma

  6. Cytokine levels-Interleukin-9 (IL-9)

    Time frame: 3 weeks

    Analysis of cytokine levels in blood. Detect the concention of Interleukin-9 (IL-9) in plasma

  7. Cytokine levels-Interleukin-4 (IL-4)

    Time frame: 3 weeks

    Analysis of cytokine levels in blood. Detect the concention of Interleukin-4 (IL-4) in plasma

  8. Cytokine levels-Tumor Necrosis Factor alpha (TNF-α)

    Time frame: 3 weeks

    Analysis of cytokine levels in blood. Detect the concention of Tumor Necrosis Factor alpha (TNF-α) in plasma

Other outcomes

  1. Transcriptomics analysis

    Time frame: 3 weeks

    Analyze the changes in peripheral blood mononuclear cells using transcriptomics. Detect the cell populations , genes number and expression.

  2. Proteomics analysis

    Time frame: 3 weeks

    Analyze the changes in peripheral blood mononuclear cells using proteomics. Detect the proteins expression.

  3. post-translational modification proteomics analysis

    Time frame: 3 weeks

    Analyze the changes in peripheral blood mononuclear cells using post-translational modification proteomics. Detect the protein various modification, such as lactylation, crotonylation, palmitoylation and methylation.

  4. metabolomics analysis

    Time frame: 3 weeks

    Analyze the changes in peripheral blood mononuclear cells using metabolomics. Detect the metabolites numbers, localization and level.

Sponsors and collaborators

Lead sponsor

Tianjin Medical University

Other

Registry information

Official study title

Interventional Study on the Treatment of Uveitis With Vitamin and Unsaturated Fatty Acid Combination Dietary Supplements Through Modulating T Cell Function

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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