Diet InterventionNCT05530499
Effects of Almonds on Immune Health and Responsiveness
A study testing Almond supplementation and Cookie supplementation in people with Diet Intervention, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This study has the primary objective of investigating the benefits of consuming whole almonds on immune health and immune response in adults with obesity. Read more about this study
- Who is it for?
- Ages 30 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Intervention
- What is being tested?
- Almond supplementation and Cookie supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to 9 Oct 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 30 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI): 30-45 kg/m^2
- Willingness to consume study foods
- Willing to comply with study protocol
- Consistent diet and activity patterns for 4 weeks
- Weight stable (no greater than 5 kg change over the last 3 months)
- Non-smoker > 1 year or more
Who cannot join
- Regular consumer of nuts
- Planning on getting viral vaccines during study
- Allergies to study foods (almonds, cookies)
- Illicit drug use
- Recent start of medications that affect metabolism or appetite
- Current use of medication that interfere with immune measures
Show all 10Show fewer
- Diabetes
- Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia
- Pregnant of lactating individuals
- Lidocaine allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65211
About this study
This study has the primary objective of investigating the benefits of consuming whole almonds on immune health and immune response in adults with obesity.
Read the detailed description
The study is a six week, randomized, controlled, and parallel arm clinical trial in which participants will be randomized to consume either 57 grams of whole almonds daily or to consume an isocaloric cookie snack daily. Outcomes assessed will include blood and adipose immune markers, cardiometabolic biomarkers, and gut microbiome.
- Conditions
- Diet Intervention
- Being tested
- Almond supplementation, Cookie supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almond supplementationOther
Daily consumption of 57g of whole almonds
Cookie supplementationOther
Daily consumption of cookie snack calorically equivalent to 57 grams of whole almonds.
| Study group | Role | What they receive |
|---|---|---|
| Almond | Experimental | Participants in this group will be instructed to consume 57 grams of whole almonds every day for six weeks. Receives: Other: Almond supplementation |
| Cookie | Active comparator | Participants in this group will be instructed to consume cookies equivalent to the energy content of 57 grams of whole almonds every day for six weeks. Receives: Other: Cookie supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in immune and inflammatory markers
Lymphocytes, granulocytes, monocytes, interleukins, cytokines, etc.
Measured: Over 6 weeks
Change in immune cell profile
Immunophenotyping
Measured: Over 6 weeks
Secondary outcomes (14)
Body mass
Measured in kg
Measured: Baseline, week 3, and week 6
Body composition
Fat mass and fat-free mass
Measured: Baseline, week 3, and week 6
Anthropometrics
Waist circumference, hip circumference, thigh circumference
Measured: Baseline, week 3, and week 6
Glucoregulation
Fasting glucose concentrations
Measured: Baseline and week 6
Insulinemic biomarker concentrations
Fasting insulin and C-peptide concentrations
Measured: Baseline and week 6
Lipid profile
LDL, HDL, triglycerides, total cholesterol
Measured: Baseline and week 6
Blood pressure
Diastolic and systolic blood pressure
Measured: Baseline, week 3, week 6
Dietary intake
24 hours dietary recall and food frequency questionnaires
Measured: Baseline, week 1, week 2, week 3, week 4, week 5, week 6
24 hour appetite ratings
24 hour appetite rating survey
Measured: Baseline, week 6
Physical activity
Activity assessment using Actigraphs
Measured: Baseline, week 6
Sleep
Sleep monitors and questionnaires
Measured: Baseline, week 6
Transcriptomics profiles
RNAseq
Measured: Baseline, week 6
Palatability rating of foods
Hedonic general labelled magnitude scale (gLMS)
Measured: Baseline, week 3, week 6
Acceptance rating of foods
9-point food action rating scale
Measured: Baseline, week 3, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start15 Sep 2022
- Primary completion9 Oct 2024
- Study completion9 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet InterventionStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Principal investigator, Jaapna Dhillon, University of Missouri-Columbia
- Investigators
- Jaapna Dhillon, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530499
- Sponsor's protocol ID
- 2090290
- Status last verified
- Dec 2024
- First submitted
- 30 Aug 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
Publications
Adepoju A, Rabbani E, Brickey P, Vieira-Potter V, Dhillon J. Almond Consumption Improves Inflammatory Profiles Independent of Weight Change: A 6-Week Randomized Controlled Trial in Adults with Obesity. Nutrients. 2026 Mar 9;18(5):875. doi: 10.3390/nu18050875.
PubMed 41830044
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Almonds on Immune Health and Responsiveness
- ClinicalTrials.gov ID
- NCT05530499
- Acronym / sponsor ID
- 2090290
- Conditions
- Diet Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 9 Oct 2024 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 7 Sep 2022 (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 study has the primary objective of investigating the benefits of consuming whole almonds on immune health and immune response in adults with obesity.
Detailed description
The study is a six week, randomized, controlled, and parallel arm clinical trial in which participants will be randomized to consume either 57 grams of whole almonds daily or to consume an isocaloric cookie snack daily. Outcomes assessed will include blood and adipose immune markers, cardiometabolic biomarkers, and gut microbiome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond | Experimental | Other: Almond supplementationParticipants in this group will be instructed to consume 57 grams of whole almonds every day for six weeks. |
| Cookie | Active comparator | Other: Cookie supplementationParticipants in this group will be instructed to consume cookies equivalent to the energy content of 57 grams of whole almonds every day for six weeks. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body mass index (BMI): 30-45 kg/m^2
- Willingness to consume study foods
- Willing to comply with study protocol
- Consistent diet and activity patterns for 4 weeks
- Weight stable (no greater than 5 kg change over the last 3 months)
Key exclusion criteria (10 listed)
- Regular consumer of nuts
- Planning on getting viral vaccines during study
- Allergies to study foods (almonds, cookies)
- Illicit drug use
- Recent start of medications that affect metabolism or appetite
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 supplementationDaily consumption of 57g of whole almonds | Other | Almond |
| Cookie supplementationDaily consumption of cookie snack calorically equivalent to 57 grams of whole almonds. | Other | Cookie |
Primary outcome
Change in immune and inflammatory markers
Time frame: Over 6 weeks
Lymphocytes, granulocytes, monocytes, interleukins, cytokines, etc.
Change in immune cell profile
Time frame: Over 6 weeks
Immunophenotyping
14 secondary outcomes
Body mass
Time frame: Baseline, week 3, and week 6
Body composition
Time frame: Baseline, week 3, and week 6
Anthropometrics
Time frame: Baseline, week 3, and week 6
Glucoregulation
Time frame: Baseline and week 6
Insulinemic biomarker concentrations
Time frame: Baseline and week 6
Lipid profile
Time frame: Baseline and week 6
Blood pressure
Time frame: Baseline, week 3, week 6
Dietary intake
Time frame: Baseline, week 1, week 2, week 3, week 4, week 5, week 6
24 hour appetite ratings
Time frame: Baseline, week 6
Physical activity
Time frame: Baseline, week 6
Sleep
Time frame: Baseline, week 6
Transcriptomics profiles
Time frame: Baseline, week 6
Palatability rating of foods
Time frame: Baseline, week 3, week 6
Acceptance rating of foods
Time frame: Baseline, week 3, week 6
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 2024.
- Derived from this study: PubMed 41830044Adepoju A, Rabbani E, Brickey P, Vieira-Potter V, Dhillon J. Almond Consumption Improves Inflammatory Profiles Independent of Weight Change: A 6-Week Randomized Controlled Trial in Adults with Obesity. Nutrients. 2026 Mar 9;18(5):875. doi: 10.3390/nu18050875.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
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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.
Jaapna Dhillon, PhD principal investigator
University of Missouri-Columbia
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 supplementation and Cookie supplementation in people with Diet Intervention, run by University of Missouri-Columbia 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 6 inclusion and 10 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 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 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 immune and inflammatory markers (time frame: Over 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05530499, which also lists 1 linked publication.
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 2024.