Immune ResponseAlmond ImmuneNCT05031663
Effect of Almonds on Immune Strength and Response to Flu Vaccination in Overweight Older Men and Postmenopausal Women: A Randomized Controlled Study
A study testing Almond group in people with Immune Response and Inflammation, run by Loma Linda University at 1 site in United States.
Trial summary
This research study will test the effects of almonds on immune functions and immune response to influenza vaccine in overweight middle-aged men and postmenopausal women Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Response, Inflammation
- What is being tested?
- Almond group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 10 May 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight men and post menopausal women (Basal Metabolic Index 25-32)
- Age limit between 40-70 years
- Be able to commute to Loma Linda University
Who cannot join
- Intolerance or allergy to almonds
- Bad dentures, inability to chew almonds
- Regular intake of almonds and or other nuts
- Use of immune boosting supplements
- Exposure to antibiotics and corticosteroids immediately prior to study
- Have received influenza vaccination in past 10 months
- Uncontrolled chronic disease and psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University School of Public Health
Loma Linda, California, 92350
About this study
Official title: Effect of Daily Consumption of Almonds on Immune Strength and Response to Flu Vaccination in Overweight Middle -Aged Men: A Randomized Controlled Study
This research study will test the effects of almonds on immune functions and immune response to influenza vaccine in overweight middle-aged men and postmenopausal women
Read the detailed description
The proposed study is a parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial on 66 overweight middle-aged men and post menopausal women. This study will be carried out in two phases: Phase 1 will examine the effects of almonds on clinically relevant markers of immune function, and Phase 2 will assess the antibody response to influenza vaccination following almond consumption. Participants will attend a baseline clinic and will be randomized to one of two groups. The Almond group will receive 15% of daily energy intake in the form of almonds as a snack and the Control group will continue thier usual diet but completely avoid almonds and restrict other nuts to less than 2 servings per week. The intervention will be for 12 weeks, at which time both group participants will receive the influenza vaccination, and continue the same dietary intervention for another 28 weeks.
- Conditions
- Immune Response, Inflammation
- Being tested
- Almond group, Control Group
- Keywords
- Almonds, Immunity, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almond groupDietary supplement
Participants in the Almond group will receive 15% of their daily energy intake in the form of almonds as a snack
Control GroupDietary supplement
The control group will continue their usual diet but will completely avoid almonds and restrict other nuts to less than 2 servings per week
| Study group | Role | What they receive |
|---|---|---|
| Almonds | Experimental | The almond group will receive 15% of their daily energy intake in the form of almonds Receives: Dietary Supplement: Almond group |
| Control | Placebo comparator | The control group will be encouraged to continue their usual diet but completely avoid almonds and restrict other nuts to less than 2 servings per week Receives: Dietary Supplement: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in lymphocyte populations
Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naïve and memory cells and B cells
Measured: baseline to 12 weeks
changes in lymphocyte activity and cytokine production
PBMC cells will be separated from blood, activated and cultured using phytohemagglutinin (PHA). Inflammatory cytokine production will be measured in the resulting supernatant using ELISA
Measured: baseline to 12 weeks
changes in natural killer (NK) cell activity
The NK degranulation assay will be performed on blood samples. The test will be conducted using a modified flow cytometry method that measures the expression of CD107a
Measured: baseline to 12 weeks
changes in serum inflammatory cytokine concentration
Changes in the concentrations of the inflammatory cytokines will be performed on serum using enzyme-linked immunoassay (ELISA)
Measured: baseline to 12 weeks
changes in complete blood count (CBC)
changes in the complete blood count will be performed on whole blood with the use of an automated hematology analyzer at a certified clinical facility
Measured: baseline to 12 weeks
Secondary outcomes (2)
changes in upper respiratory infection questionnaire score
Upper respiratory tract infections will be tracked using the Jackson and Dowling questionnaire. The questionnaire will be completed daily by participants, either manually or electronically , throughout the 28-week study period. The scale for the questionnaire is from 0-42. The higher score means worse outcome.
Measured: baseline to 28 weeks
changes in blood zinc levels
Zinc levels in blood will be analyzed in trace element- free tubes and assayed by atomic absorption spectrophotometry using standard reference material obtained from the National Institute of Standards and Technology to check the accuracy and precision of the determinations
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start12 Aug 2021
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ResponseStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- this will be a parallel, free-living, randomized controlled trial, where 66 middle-aged men and post menopausal women will be randomized to receive either the almonds or control
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Sabate,DrPH, MD, Loma Linda University
- Investigators
- Joan Sabate, DrPh, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031663
- Sponsor's protocol ID
- 5210259
- Acronym
- Almond Immune
- Status last verified
- Dec 2025
- First submitted
- 6 Jul 2021
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Consumption of Almonds on Immune Strength and Response to Flu Vaccination in Overweight Middle -Aged Men: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05031663
- Acronym / sponsor ID
- Almond Immune / 5210259
- Conditions
- Immune Response, Inflammation
- Keywords
- Almonds, Immunity, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 2 Sep 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.
This research study will test the effects of almonds on immune functions and immune response to influenza vaccine in overweight middle-aged men and postmenopausal women
Detailed description
The proposed study is a parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial on 66 overweight middle-aged men and post menopausal women. This study will be carried out in two phases: Phase 1 will examine the effects of almonds on clinically relevant markers of immune function, and Phase 2 will assess the antibody response to influenza vaccination following almond consumption. Participants will attend a baseline clinic and will be randomized to one of two groups. The Almond group will receive 15% of daily energy intake in the form of almonds as a snack and the Control group will continue thier usual diet but completely avoid almonds and restrict other nuts to less than 2 servings per week. The intervention will be for 12 weeks, at which time both group participants will receive the influenza vaccination, and continue the same dietary intervention for another 28 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- this will be a parallel, free-living, randomized controlled trial, where 66 middle-aged men and post menopausal women will be randomized to receive either the almonds or control
| Arm | Type | Receives |
|---|---|---|
| Almonds | Experimental | Dietary Supplement: Almond groupThe almond group will receive 15% of their daily energy intake in the form of almonds |
| Control | Placebo comparator | Dietary Supplement: Control GroupThe control group will be encouraged to continue their usual diet but completely avoid almonds and restrict other nuts to less than 2 servings per week |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight men and post menopausal women (Basal Metabolic Index 25-32)
- Age limit between 40-70 years
- Be able to commute to Loma Linda University
Key exclusion criteria (7 listed)
- Intolerance or allergy to almonds
- Bad dentures, inability to chew almonds
- Regular intake of almonds and or other nuts
- Use of immune boosting supplements
- Exposure to antibiotics and corticosteroids immediately prior to study
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 groupParticipants in the Almond group will receive 15% of their daily energy intake in the form of almonds as a snack | Dietary supplement | Almonds |
| Control GroupThe control group will continue their usual diet but will completely avoid almonds and restrict other nuts to less than 2 servings per week | Dietary supplement | Control |
Primary outcome
changes in lymphocyte populations
Time frame: baseline to 12 weeks
Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naïve and memory cells and B cells
changes in lymphocyte activity and cytokine production
Time frame: baseline to 12 weeks
PBMC cells will be separated from blood, activated and cultured using phytohemagglutinin (PHA). Inflammatory cytokine production will be measured in the resulting supernatant using ELISA
changes in natural killer (NK) cell activity
Time frame: baseline to 12 weeks
The NK degranulation assay will be performed on blood samples. The test will be conducted using a modified flow cytometry method that measures the expression of CD107a
changes in serum inflammatory cytokine concentration
Time frame: baseline to 12 weeks
Changes in the concentrations of the inflammatory cytokines will be performed on serum using enzyme-linked immunoassay (ELISA)
changes in complete blood count (CBC)
Time frame: baseline to 12 weeks
changes in the complete blood count will be performed on whole blood with the use of an automated hematology analyzer at a certified clinical facility
2 secondary outcomes
changes in upper respiratory infection questionnaire score
Time frame: baseline to 28 weeks
changes in blood zinc levels
Time frame: baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Joan Sabate, DrPh principal investigator
Loma Linda University
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 group in people with Immune Response and Inflammation, run by Loma Linda University at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 9 Dec 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 lymphocyte populations (time frame: baseline to 12 weeks). The study lists 5 primary outcomes in all. 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 9 Dec 2025.