Effects of Almond Consumption on Innate and Adaptive Immune System

Immune System Clinical Trial

— AlmondIS  

Official title:

Effects of Almond Consumption on Innate Myeloid and Lymphoid Cells Composition and Activity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05026242
• Other study ID #: IH-21-BULLOM-NR-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Institut Investigacio Sanitaria Pere Virgili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI 25.0-34.9 Kg/m2

• Western-style diet

• Unhealthy snacks other than nuts (i.e. potato chips, crackers, corn puffs, pretzels, pastries, cookies, candies) >1 serving/day

Exclusion Criteria:

• Regular smokers (= 10 cigarettes/day)

• Diagnoses of type 2 diabetes

• Cardiovascular disease, chronic kidney disease, liver disease, active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption, cancer - active malignant cancer or history of malignancy within the last 5 years, psychiatric disorders

• Use of anti-inflammatory or antioxidants drugs

• Not stable medication in the last 3 months

• Regular alcohol consumption above of the national recommendations or drug abuse

• Frequent consumption of nuts

• Allergy to the intervention products or other severe allergies and food intolerances

• Dietary patterns interfering with the study protocol (e.g. vegetarian, vegan, low carbohydrate dieters, high fat dieters) two months prior inclusion, during the study or plans to initiate during the study

• Daily use of multivitamin or mineral supplements

• Bad dentures, implying difficulty to chew nut

• Pregnancy or lactation, pregnancy within the past 12 month or plans to become pregnant during the study

• Consumption of probiotics or prebiotics in the last 3 months and laxatives

Related Conditions & MeSH terms

• Immune System

Intervention

Behavioral:
• Almond intervention
Participants will follow their regular Western-style diet substituting unhealthy snacks by 2-daily servings of almonds
• Control
Participants will be provided with isocaloric snacks

Locations

Country	Name	City	State
Spain	IISPV	Reus	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Investigacio Sanitaria Pere Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in circulating miRNAs	20 circulating miRNA will be measured using TaqMan MicroRNA Assays. Results will be expressed as relative increase or decrease	These outcomes will be assessed at baseline and at 8 weeks
Other	Changes in gut microbiota composition	16S RNA will be sequenced and functional in silico analyses using existing datasets will be conducted. Data will be expressed in relative abundace (OTUS/ASV) at genus, family and/or specie level	These outcomes will be assessed at baseline and at 8 weeks
Other	Changes in gut microbiota function	Fecal targeted quantitative metabolomic multi-platform analyses will be conducted to identify changes in fecal metabolites related to the intervention (different metabolites including lipid species, aminoacids, bile acids, short-chain fatty acids...will be included)	These outcomes will be assessed at baseline and at 8 weeks
Other	Changes in circulating metabolites concentrations	We will use a multi-platform targeted/untargeted approach to identify/quantify metabolites related to the intervention and outcomes. (different metabolites including lipid species, aminoacids, bile acids, short-chain fatty acids...will be included)	These outcomes will be assessed at baseline and at 8 weeks
Primary	Changes in innate myeloid and lymphoid cells	CD45+, CD103+, CD56+, CD14+,CD16+, CD8+, CD19+, CD4+, CD3+, CD36+, CD44+, ROR ? t, NKp46+, FoxP3+ will be assessed by means of flow cytometry in cryopreserved cells.	These outcomes will be assessed at baseline and at 8 weeks
Secondary	Changes in lymphocyte subsets	Lymphocyte subsets will be measured using Ficoll-Paque (GE Healthcare) density gradient centrifugation and flow cytometry. Results will be expressed in 10 (9)/L cells	These outcomes will be assessed at baseline and at 8 weeks
Secondary	Changes in immune cells activity assessed by citokyne production	Innate lymphoid and myeloid cells activity will be assessed in cryopreserved PBMCs. Inflammation mediators ( such as hs-CRP, IL1, IL2, IL4, IL-6, IL-7, IL-10, TNFa, IFN-?, TGF-ß, TLR4, NOD1) will be assessed with chemical assays (ELISA). Results will be expressed as mass/volume	These outcomes will be assessed at baseline and at 8 weeks
Secondary	Changes in immune cells activity assessed by adaptor molecules	A study of the molecular signaling using Western blot qauntification of adaptor molecules that play a pivotal role in immune cell activation through Toll-like receptors and therefore are good markers for specific immune cells activities	These outcomes will be assessed at baseline and at 8 weeks
Secondary	Changes in inflammatory markers and related molecules in plasma/serum	Several citokynes related immune cells (i.e TNF, IL6, IL1) and other circulating inflmmatory markers (i.e. CRP, amiloid) will be measured by ELISA related methods. Results will be expressed in mass/volume	These outcomes will be assessed at baseline and at 8 weeks