Effects of Almond Consumption on Innate and Adaptive Immune System

NCT05026242 | Active Not Recruiting

• 1 other identifier: IH-21-BULLOM-NR-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune System

Keywords

almonds; innate myeloid; lymphoid cells; immune function; miRNAs

Outcome Measures

Primary Outcomes (1)

• Changes in innate myeloid and lymphoid cells

  CD45+, CD103+, CD56+, CD14+,CD16+, CD8+, CD19+, CD4+, CD3+, CD36+, CD44+, ROR γ 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 Outcomes (4)

• Changes in lymphocyte subsets

  These outcomes will be assessed at baseline and at 8 weeks

• Changes in immune cells activity assessed by citokyne production

  These outcomes will be assessed at baseline and at 8 weeks

• Changes in immune cells activity assessed by adaptor molecules

  These outcomes will be assessed at baseline and at 8 weeks

• Changes in inflammatory markers and related molecules in plasma/serum

  These outcomes will be assessed at baseline and at 8 weeks

Other Outcomes (4)

• Changes in circulating miRNAs

  These outcomes will be assessed at baseline and at 8 weeks

• Changes in gut microbiota composition

  These outcomes will be assessed at baseline and at 8 weeks

• Changes in gut microbiota function

  These outcomes will be assessed at baseline and at 8 weeks

Study Arms (2)

Almond intervention

EXPERIMENTAL

Participants will follow their regular Western-style diet substituting unhealthy snacks by 2-daily servings of almonds

Behavioral: Almond intervention

Control

ACTIVE COMPARATOR

Participants will be provided with isocaloric snacks

Behavioral: Control

Interventions

Almond intervention BEHAVIORAL

Participants will follow their regular Western-style diet substituting unhealthy snacks by 2-daily servings of almonds

Almond intervention

Control BEHAVIORAL

Participants will be provided with isocaloric snacks

Control

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead

Study Sites (1)

IISPV

Reus, Tarragona, 43201, Spain

Location

Study Officials

• Monica Bullo, Prof

  Pere Virgili

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 30, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)