Immunological StatusCricoImNutNCT07496320
Critical Food Ingredients on Immunocompetence to Prevent the Risk and Development of Obesity/Metabolic Syndrome
A study testing Administration of a commercial cookie formulation and Immunonutritional_2 in people with Immunological Status and Healthy Volunteers, run by IMDEA Food at 1 site in Spain.
Trial summary
Double-blind cross-over intervention where the volunteers were randomized into two groups who, after receiving nutritional counseling, received two formulations in the form of a cookie: Group 1, commercial formulation and Group 2, a C. quinoa-based formulation for 12 days. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunological Status, Healthy Volunteers, Healthy Volunteers - Male and Female
- What is being tested?
- Administration of a commercial cookie formulation and Immunonutritional_2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 23 Oct 2024to 23 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy status,
- Understanding of the objectives
- Accep to consume cookies
Who cannot join
- Pregnant, breastfeeding, decreased cognition function, pharmacological treatment
- Individuals with or who had suffered cardiovascular, hepatic, renal, or inflammatory disease
- Refuse to consume the cookies, had allergy/intolerance to any of the components of the product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Replacement of Critical Ingredients in Cookies on Immunocompetence in Healthy Population for the Prevention of Risk and Development of Obesity/Metabolic Syndrome
Double-blind cross-over intervention where the volunteers were randomized into two groups who, after receiving nutritional counseling, received two formulations in the form of a cookie: Group 1, commercial formulation and Group 2, a C. quinoa-based formulation for 12 days. Volunteers received nutritional advice and did not undergo dietary limitation(s) along the study periods. After the first period, volunteers underwent a washout stage before being included in the group to receive the opposite treatment to that received in the first stage. Blood and fecal samples were taken at both initial (i.e., visit 1, visit V3) and final (visit V2, visit 4) check-up visits from the volunteers at each study period.
- Being tested
- Administration of a commercial cookie formulation, Immunonutritional_2
- Keywords
- Immunonutrition, innate lymphoid cells, monocytes, triglycerides, insulin, HDL, Apo_A
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of a commercial cookie formulationDietary supplement
Volunteers received two cookies - 1st a commercial formulation and 2nd a novel formulation
Immunonutritional_2Dietary supplement
Volunteers receive two cookies - 1st a novel formulation and 2nd a commercial formulation
| Study group | Role | What they receive |
|---|---|---|
| Immunonutritional_1 | Active comparator | Volunteers receive a commercial formulation as positive control of the effect Receives: Dietary Supplement: Administration of a commercial cookie formulation; Dietary Supplement: Immunonutritional_2 |
| Immunonutritional_2 | Active comparator | Patients receive a novel formulation to compare the effects in the level of biomarkers Receives: Dietary Supplement: Administration of a commercial cookie formulation; Dietary Supplement: Immunonutritional_2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of triglycerides
Influence of the formulation(s) to preserve the peripheral physiological level of triglycerides (below 150 mg/dL)
Measured: Twelve days
Blood levels of cholesterol_LDL
Influence of the formulation(s) to preserve the peripheral physiological levels of Cholesterol_LDL (below 100 mg/dL)
Measured: Twelve days
Blood levels of insulin
Influence of the formulations to preserve the peripheral physiological level of insulin (fasting insulin between 2.6 - 24.9 µIU/mL)
Measured: Twelve days
Blood levels of cholesterol_HDL
Influence of the formulation(s) to preserve the peripheral physiological levels of Cholesterol_HDL (between 40-60 mg/dL)
Measured: Twelve days
Secondary outcomes (6)
Peripheral blood monocytes
Impact of the formulation in the proportion (% relative to the total CD45+ population) of peripheral monocytes with a phenotype CD45+CD33+CX3CR1+
Measured: Twelve days
Safety and tolerance
Values of GPT (between 5-37 U/L)
Measured: Twelve days
Antropometry
Parameters as 'body weight' (kilograms) and height (meters) will be aggregated to calculate the 'body mass index (BMI)' (kg/m^2)
Measured: Twelve days
Blood levels of glucose
Impact of the formulation(s) in the fasting glycaemia (levels between 80-110 mg/dL)
Measured: Twelve days
Blood concentration of innate lymphoid cell precursors
Impact of the formulation(s) in the proportion (% relative to the total CD117+ cells) of innate lymphoid precursors with a phenotype CD117+KLRG1+
Measured: Twelve days
Safety and tolerance
Values of GOT (between 5-50 U/L)
Measured: Twelve days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start23 Oct 2024
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunological StatusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMDEA Food
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496320
- Sponsor's protocol ID
- IMD PI -053
- Other IDs
- PID2019-107650RB-C22
- Acronym
- CricoImNut
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Replacement of Critical Ingredients in Cookies on Immunocompetence in Healthy Population for the Prevention of Risk and Development of Obesity/Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07496320
- Acronym / sponsor ID
- CricoImNut / IMD PI -053
- Keywords
- Immunonutrition, innate lymphoid cells, monocytes, triglycerides, insulin, HDL, Apo_A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IMDEA FoodUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 27 Mar 2026 (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.
Double-blind cross-over intervention where the volunteers were randomized into two groups who, after receiving nutritional counseling, received two formulations in the form of a cookie: Group 1, commercial formulation and Group 2, a C. quinoa-based formulation for 12 days. Volunteers received nutritional advice and did not undergo dietary limitation(s) along the study periods. After the first period, volunteers underwent a washout stage before being included in the group to receive the opposite treatment to that received in the first stage. Blood and fecal samples were taken at both initial (i.e., visit 1, visit V3) and final (visit V2, visit 4) check-up visits from the volunteers at each study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunonutritional_1 | Active comparator | Dietary Supplement: Administration of a commercial cookie formulation, Dietary Supplement: Immunonutritional_2Volunteers receive a commercial formulation as positive control of the effect |
| Immunonutritional_2 | Active comparator | Dietary Supplement: Administration of a commercial cookie formulation, Dietary Supplement: Immunonutritional_2Patients receive a novel formulation to compare the effects in the level of biomarkers |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy status,
- Understanding of the objectives
- Accep to consume cookies
Key exclusion criteria (3 listed)
- Pregnant, breastfeeding, decreased cognition function, pharmacological treatment
- Individuals with or who had suffered cardiovascular, hepatic, renal, or inflammatory disease
- Refuse to consume the cookies, had allergy/intolerance to any of the components of the product
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 |
|---|---|---|
| Administration of a commercial cookie formulationVolunteers received two cookies - 1st a commercial formulation and 2nd a novel formulation | Dietary supplement | Immunonutritional_1, Immunonutritional_2 |
| Immunonutritional_2Volunteers receive two cookies - 1st a novel formulation and 2nd a commercial formulation | Dietary supplement | Immunonutritional_1, Immunonutritional_2 |
Primary outcome
Blood levels of triglycerides
Time frame: Twelve days
Influence of the formulation(s) to preserve the peripheral physiological level of triglycerides (below 150 mg/dL)
Blood levels of cholesterol_LDL
Time frame: Twelve days
Influence of the formulation(s) to preserve the peripheral physiological levels of Cholesterol_LDL (below 100 mg/dL)
Blood levels of insulin
Time frame: Twelve days
Influence of the formulations to preserve the peripheral physiological level of insulin (fasting insulin between 2.6 - 24.9 µIU/mL)
Blood levels of cholesterol_HDL
Time frame: Twelve days
Influence of the formulation(s) to preserve the peripheral physiological levels of Cholesterol_HDL (between 40-60 mg/dL)
6 secondary outcomes
Peripheral blood monocytes
Time frame: Twelve days
Safety and tolerance
Time frame: Twelve days
Antropometry
Time frame: Twelve days
Blood levels of glucose
Time frame: Twelve days
Blood concentration of innate lymphoid cell precursors
Time frame: Twelve days
Safety and tolerance
Time frame: Twelve days
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 27 Mar 2026.
- Individual participant dataSharing planned: No. Confidentiality
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of a commercial cookie formulation and Immunonutritional_2 in people with Immunological Status and Healthy Volunteers, run by IMDEA Food 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 3 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 27 Mar 2026. 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?
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?
Blood levels of triglycerides (time frame: Twelve days). The study lists 4 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 27 Mar 2026.