Clinical trial NCT05026242: Effects of Almond Consumption on Innate and Adaptive Immune System
Official title: Effects of Almond Consumption on Innate Myeloid and Lymphoid Cells Composition and Activity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Immune System
Keywords: almonds
innate myeloid
lymphoid cells
immune function
miRNAs
Lead sponsor: Institut Investigacio Sanitaria Pere Virgili
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in innate myeloid and lymphoid cells
timeFrame: These outcomes will be assessed at baseline and at 8 weeks
Secondary outcomes:
measure: Changes in lymphocyte subsets
timeFrame: These outcomes will be assessed at baseline and at 8 weeks
measure: Changes in immune cells activity assessed by citokyne production
timeFrame: These outcomes will be assessed at baseline and at 8 weeks
measure: Changes in immune cells activity assessed by adaptor molecules
timeFrame: These outcomes will be assessed at baseline and at 8 weeks
measure: Changes in inflammatory markers and related molecules in plasma/serum
timeFrame: These outcomes will be assessed at baseline and at 8 weeks
Other outcomes:
measure: Changes in circulating miRNAs
timeFrame: These outcomes will be assessed at baseline and at 8 weeks
measure: Changes in gut microbiota composition
timeFrame: These outcomes will be assessed at baseline and at 8 weeks
measure: Changes in gut microbiota function
timeFrame: These outcomes will be assessed at baseline and at 8 weeks
measure: Changes in circulating metabolites concentrations
timeFrame: These outcomes will be assessed at baseline and at 8 weeks
Locations:
city: Reus
country: Spain
facility: IISPV
state: Tarragona
Study officials:
affiliation: Pere Virgili
name: Monica Bullo, Prof
role: PRINCIPAL_INVESTIGATOR
References: