Critical Food Ingredients on Immunocompetence to Prevent the Risk and Development of Obesity/Metabolic Syndrome (CricoImNut)

March 23, 2026 updated by: IMDEA Food

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28049
        • IMDEA Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy status,
  • Understanding of the objectives
  • Accep to consume cookies

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Immunonutritional_1
Volunteers receive a commercial formulation as positive control of the effect
Dietary supplement: Administration of a commercial cookie formulation
Volunteers received two cookies - 1st a commercial formulation and 2nd a novel formulation
Dietary supplement: Immunonutritional_2
Volunteers receive two cookies - 1st a novel formulation and 2nd a commercial formulation
Active Comparator: Immunonutritional_2
Patients receive a novel formulation to compare the effects in the level of biomarkers
Dietary supplement: Administration of a commercial cookie formulation
Volunteers received two cookies - 1st a commercial formulation and 2nd a novel formulation
Dietary supplement: Immunonutritional_2
Volunteers receive two cookies - 1st a novel formulation and 2nd a commercial formulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Twelve days
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)
Twelve days
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)
Twelve days
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)
Twelve days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peripheral blood monocytes
Time Frame: Twelve days
Impact of the formulation in the proportion (% relative to the total CD45+ population) of peripheral monocytes with a phenotype CD45+CD33+CX3CR1+
Twelve days
Safety and tolerance
Time Frame: Twelve days
Values of GPT (between 5-37 U/L)
Twelve days
Antropometry
Time Frame: Twelve days
Parameters as 'body weight' (kilograms) and height (meters) will be aggregated to calculate the 'body mass index (BMI)' (kg/m^2)
Twelve days
Blood levels of glucose
Time Frame: Twelve days
Impact of the formulation(s) in the fasting glycaemia (levels between 80-110 mg/dL)
Twelve days
Blood concentration of innate lymphoid cell precursors
Time Frame: Twelve days
Impact of the formulation(s) in the proportion (% relative to the total CD117+ cells) of innate lymphoid precursors with a phenotype CD117+KLRG1+
Twelve days
Safety and tolerance
Time Frame: Twelve days
Values of GOT (between 5-50 U/L)
Twelve days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IMDEA Food

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMD PI -053
  • PID2019-107650RB-C22 (Other Grant/Funding Number: Ministerio de Ciencia e Innovación (Spain))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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