NCT07496320

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

Study of Replacement of Critical Ingredients in Cookies on Immunocompetence in Healthy Population for the Prevention of Risk and Development of Obesity/Metabolic Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: IMDEA Food · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Immunological Status
• Healthy Volunteers
• Healthy Volunteers - Male and Female

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-23
• Primary completion: 2024-10-23
• Completion: 2024-10-23
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Spain