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

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: Completed
• Conditions: Healthy Volunteers; Immunological Status; Healthy Volunteers - Male and Female
• Intervention / Treatment: Dietary supplement: Administration of a commercial cookie formulation; Dietary supplement: Immunonutritional_2

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Blood levels of triglycerides	Influence of the formulation(s) to preserve the peripheral physiological level of triglycerides (below 150 mg/dL)	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)	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)	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)	Twelve days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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+	Twelve days
Safety and tolerance	Values of GPT (between 5-37 U/L)	Twelve days
Antropometry	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	Impact of the formulation(s) in the fasting glycaemia (levels between 80-110 mg/dL)	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+	Twelve days
Safety and tolerance	Values of GOT (between 5-50 U/L)	Twelve days

Collaborators and Investigators

• Sponsor: IMDEA Food

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2024
• Primary Completion (Actual): October 23, 2024
• Study Completion (Actual): October 23, 2024

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: insulin; Immunonutrition; triglycerides; HDL; monocytes; innate lymphoid cells; Apo_A
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Nutritional and Metabolic Diseases; Insulin Resistance
• Other Study ID 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