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Completed

NCT Number: NCT07496320

Critical Food Ingredients on Immunocompetence to Prevent the 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.

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Key information

Conditions

Immunological Status Glucose Metabolism Disorders Healthy Volunteers Healthy Volunteers - Male and Female Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IMDEA Nutrition

Madrid, 28049, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of a commercial cookie formulation

Dietary Supplement

Volunteers received two cookies - 1st a commercial formulation and 2nd a novel formulation

Immunonutritional_2

Dietary Supplement

Volunteers receive two cookies - 1st a novel formulation and 2nd a commercial formulation

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. 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+

  2. Safety and tolerance

    Time frame: Twelve days

    Values of GPT (between 5-37 U/L)

  3. 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)

  4. Blood levels of glucose

    Time frame: Twelve days

    Impact of the formulation(s) in the fasting glycaemia (levels between 80-110 mg/dL)

  5. 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+

  6. Safety and tolerance

    Time frame: Twelve days

    Values of GOT (between 5-50 U/L)

Sponsors and collaborators

Lead sponsor

IMDEA Food

Other

Registry information

Official study 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

Acronym: CricoImNut

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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