Immune HealthNCT05059639
Exploring the Role of Almonds in Enhancing Immune Strength
A study testing Almond and Pretzel in people with Immune Health, run by San Diego State University at 1 site in United States.
Trial summary
The COVID-19 pandemic highlights the importance of good nutritional status for immune strength and for reducing comorbidities that increase morbidity and mortality of infections. The major aim of this study is test if almond consumption can improve immune function. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Immune Health
- What is being tested?
- Almond and Pretzel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 15 Nov 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects aged 40-65 y
- Body mass index (BMI) 24-30 kg/m.2
Who cannot join
- Not willing to stop taking multivitamins, and supplements (with the exception of vitamin D and calcium), for 30 days prior to or during study participation, if currently taking these.
- Almond allergies
- Alcohol consumption >2 drinks per day.
- Smoking or using nicotine containing products in the last 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mark Kern, PhD, RD
San Diego, California, 92182-7251
About this study
The COVID-19 pandemic highlights the importance of good nutritional status for immune strength and for reducing comorbidities that increase morbidity and mortality of infections. The major aim of this study is test if almond consumption can improve immune function.
Read the detailed description
Investigators will conduct an 8-week parallel-arm trial of 48 overweight/non-obese (BMI=24-30) adult (aged 40-65 years) men (n=24) and women (n=24) who will be randomly assigned to consume daily isoenergetic portions of almonds or a common snack (pretzels).
- Conditions
- Immune Health
- Being tested
- Almond, Pretzel
- Keywords
- Almonds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondOther
Consume 2 ounces of almond daily for 8 weeks
PretzelOther
Consume comparative amount of pretzel daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Almond (2 ounces) | Experimental | Consume 2 ounces almond daily for 8 weeks Receives: Other: Almond |
| Pretzel | Active comparator | Consume comparative amount of pretzel for 8 weeks Receives: Other: Pretzel |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Natural Killer Function
The ability of peripheral blood mononuclear cells to bind and kill leukemia cells will be measured at baseline and at week-8 of the diet intervention using flowcytometry by assessing the concentration of natural killer cells.
Measured: Baseline, after 8 weeks
Secondary outcomes (1)
change in Cytokines
Peripheral blood will be analyzed at baseline and week-8 of diet intervention for cytokines including IL1, IL-6 and TNF alpha concentrations.
Measured: Baseline, after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start15 Nov 2021
- Primary completion15 Nov 2023
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune HealthStudies of the same condition, open and under way.
- More trials run by San Diego State 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- forty-eight overweight/non-obese (BMI=24-30) adult (ages 40-65 years) men (n=24) and women (n=24) will be recruited to participate. A randomized, parallel-arm design will be utilized.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Kern, San Diego State University
- Investigators
- Shirin Hooshmand, PhD, RD, Study director, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059639
- Sponsor's protocol ID
- 2021-06-18
- Status last verified
- Jan 2025
- First submitted
- 5 Mar 2021
- Last updated
- 31 Jan 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 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Almonds in Enhancing Immune Strength
- ClinicalTrials.gov ID
- NCT05059639
- Acronym / sponsor ID
- 2021-06-18
- Conditions
- Immune Health
- Keywords
- Almonds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 28 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.
The COVID-19 pandemic highlights the importance of good nutritional status for immune strength and for reducing comorbidities that increase morbidity and mortality of infections. The major aim of this study is test if almond consumption can improve immune function.
Detailed description
Investigators will conduct an 8-week parallel-arm trial of 48 overweight/non-obese (BMI=24-30) adult (aged 40-65 years) men (n=24) and women (n=24) who will be randomly assigned to consume daily isoenergetic portions of almonds or a common snack (pretzels).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- forty-eight overweight/non-obese (BMI=24-30) adult (ages 40-65 years) men (n=24) and women (n=24) will be recruited to participate. A randomized, parallel-arm design will be utilized.
| Arm | Type | Receives |
|---|---|---|
| Almond (2 ounces) | Experimental | Other: AlmondConsume 2 ounces almond daily for 8 weeks |
| Pretzel | Active comparator | Other: PretzelConsume comparative amount of pretzel for 8 weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male and female subjects aged 40-65 y
- Body mass index (BMI) 24-30 kg/m.2
Key exclusion criteria (4 listed)
- Not willing to stop taking multivitamins, and supplements (with the exception of vitamin D and calcium), for 30 days prior to or during study participation, if currently taking these.
- Almond allergies
- Alcohol consumption >2 drinks per day.
- Smoking or using nicotine containing products in the last 6 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 |
|---|---|---|
| AlmondConsume 2 ounces of almond daily for 8 weeks | Other | Almond (2 ounces) |
| PretzelConsume comparative amount of pretzel daily for 8 weeks | Other | Pretzel |
Primary outcome
change in Natural Killer Function
Time frame: Baseline, after 8 weeks
The ability of peripheral blood mononuclear cells to bind and kill leukemia cells will be measured at baseline and at week-8 of the diet intervention using flowcytometry by assessing the concentration of natural killer cells.
1 secondary outcome
change in Cytokines
Time frame: Baseline, after 8 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 31 Jan 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.
Shirin Hooshmand, PhD, RD study director
San Diego State 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 and Pretzel in people with Immune Health, run by San Diego State 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 2 inclusion and 4 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 31 Jan 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. 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?
change in Natural Killer Function (time frame: Baseline, after 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 31 Jan 2025.