Effects of Almond Consumption on Innate & Adaptive Immune System

Status Active, not recruiting

Clinical Trial Summary

Almonds are a rich matrix of different nutrients with demonstrated benefits on immune system. This proposal examines the effect of regular consumption of almonds on innate and adaptive immune system in healthy individuals with overweight regularly consuming a Western-style diet and unhealthy snacks.

Clinical Trial Description

In the last months, with the whole world grappling with COVID-19 and because like in many other diseases, the host immune system determines the progress of COVID-19 and the severity, there is a frantic race for finding treatment strategies based on current knowledge until effective vaccine is developed. Therefore, the modulation of inflammatory response and cytokine production using immunonutrition makes more sense than ever. The almond is a tree nut, rich in fiber, vitamin E, biotin, minerals such as magnesium and phytonutrients, specifically flavonoids, plant sterols, phenolic acids and could have a potential beneficial role in immune system. However, beyond its beneficial role and down-lowering specific circulating cytokines in low-grade chronic inflammatory diseases, the role of almond on both innate and adaptive immune system has not been explored. The investigators hypothesize that regular consumption of almonds will contribute to strengthening the immune system through the modulation of specific circulating miRNAs. The primary objective is to evaluate the effect of almond consumption on the maturation of innate lymphoid cells (ILCs). Secondarily, the insvestigators aims to: 1. Examine the effect of regular consumption of almonds in the context of a Western-style diet on: a) innate immune system through the analysis of other blood cell populations including monocytes and lymphocyte's subsets (T-cells, B-cells). b) adaptive immune system assessed by: b.1) circulating inflammatory markers and b.2) ex-vivo ability for peripheral blood mononuclear cell (PBMC) to produce cytokines. c) circulating miRNAs, focusing in immune-related miRNAs. 2. To investigate whether changes in miRNAs mediate the effect of almonds on ILCs activity and the other innate and adaptive immune system indicators analysed. The expected results would enhance understanding of the role of almonds in immune function, to establish the basis of new research for the promotion of the health benefits of nuts in immune-related diseases and facilitate the use of personalized nutrition to improve human health. ;

Study Design

Related Conditions & MeSH terms

Immune System

Clinical Trial Details

NCT number	NCT05026242
Study type	Interventional
Source	Institut Investigacio Sanitaria Pere Virgili
Contact
Status	Active, not recruiting
Phase	N/A
Start date	September 1, 2021
Completion date	December 31, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects of Almond Consumption on Innate and Adaptive Immune System — AlmondIS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms