Immune SystemAlmondISNCT05026242
Effects of Almond Consumption on Innate and Adaptive Immune System
A study testing Almond intervention in people with Immune System, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System
- What is being tested?
- Almond intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Almond Consumption on Innate Myeloid and Lymphoid Cells Composition and Activity
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.
Read the 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:
- 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.
- circulating miRNAs, focusing in immune-related miRNAs.
- 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.
- Conditions
- Immune System
- Being tested
- Almond intervention, Control
- Keywords
- almonds, innate myeloid, lymphoid cells, immune function, miRNAs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almond interventionBehavioural
Participants will follow their regular Western-style diet substituting unhealthy snacks by 2-daily servings of almonds
ControlBehavioural
Participants will be provided with isocaloric snacks
| Study group | Role | What they receive |
|---|---|---|
| Almond intervention | Experimental | Participants will follow their regular Western-style diet substituting unhealthy snacks by 2-daily servings of almonds Receives: Behavioral: Almond intervention |
| Control | Active comparator | Participants will be provided with isocaloric snacks Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: These outcomes will be assessed at baseline and at 8 weeks
Secondary outcomes (4)
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
Measured: These outcomes will be assessed at baseline and at 8 weeks
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, TNFα, IFN-γ, TGF-β, TLR4, NOD1) will be assessed with chemical assays (ELISA). Results will be expressed as mass/volume
Measured: These outcomes will be assessed at baseline and at 8 weeks
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
Measured: These outcomes will be assessed at baseline and at 8 weeks
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
Measured: These outcomes will be assessed at baseline and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica Bullo, Prof, Principal investigator, Pere Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026242
- Sponsor's protocol ID
- IH-21-BULLOM-NR-01
- Acronym
- AlmondIS
- Status last verified
- Jun 2024
- First submitted
- 15 Jul 2021
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be upon request directly to the PI
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Almond Consumption on Innate Myeloid and Lymphoid Cells Composition and Activity
- ClinicalTrials.gov ID
- NCT05026242
- Acronym / sponsor ID
- AlmondIS / IH-21-BULLOM-NR-01
- Conditions
- Immune System
- Keywords
- almonds, innate myeloid, lymphoid cells, immune function, miRNAs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- circulating miRNAs, focusing in immune-related miRNAs.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond intervention | Experimental | Behavioral: Almond interventionParticipants will follow their regular Western-style diet substituting unhealthy snacks by 2-daily servings of almonds |
| Control | Active comparator | Behavioral: ControlParticipants will be provided with isocaloric snacks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Almond interventionParticipants will follow their regular Western-style diet substituting unhealthy snacks by 2-daily servings of almonds | Behavioural | Almond intervention |
| ControlParticipants will be provided with isocaloric snacks | Behavioural | Control |
Primary outcome
Changes in innate myeloid and lymphoid cells
Time frame: These outcomes will be assessed at baseline and at 8 weeks
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.
4 secondary outcomes
Changes in lymphocyte subsets
Time frame: These outcomes will be assessed at baseline and at 8 weeks
Changes in immune cells activity assessed by citokyne production
Time frame: These outcomes will be assessed at baseline and at 8 weeks
Changes in immune cells activity assessed by adaptor molecules
Time frame: These outcomes will be assessed at baseline and at 8 weeks
Changes in inflammatory markers and related molecules in plasma/serum
Time frame: These outcomes will be assessed at baseline and at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No. Data sharing will be upon request directly to the PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Bullo, Prof principal investigator
Pere Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almond intervention in people with Immune System, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in innate myeloid and lymphoid cells (time frame: These outcomes will be assessed at baseline and at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.