An interventional study of Administration of a commercial cookie formulation and Immunonutritional_2 in Immunological Status, Healthy Volunteers and Healthy Volunteers - Male and Female, sponsored by IMDEA Food. Completed at 1 site in Spain. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by IMDEA Food · Not applicable, Interventional, and Prevention
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.
2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.
This study's enrollment of 60 is above the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.
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Exclusion Criteria:
Volunteers receive a commercial formulation as positive control of the effect
Dietary Supplement: Administration of a commercial cookie formulation · Dietary Supplement: Immunonutritional_2
Patients receive a novel formulation to compare the effects in the level of biomarkers
Dietary Supplement: Administration of a commercial cookie formulation · Dietary Supplement: Immunonutritional_2
Volunteers received two cookies - 1st a commercial formulation and 2nd a novel formulation
Volunteers receive two cookies - 1st a novel formulation and 2nd a commercial formulation
Blood levels of triglycerides
Influence of the formulation(s) to preserve the peripheral physiological level of triglycerides (below 150 mg/dL)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Twelve days
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+
Time frame: Twelve days
Safety and tolerance
Values of GPT (between 5-37 U/L)
Time frame: Twelve days
Antropometry
Parameters as 'body weight' (kilograms) and height (meters) will be aggregated to calculate the 'body mass index (BMI)' (kg/m\^2)
Time frame: Twelve days
Blood levels of glucose
Impact of the formulation(s) in the fasting glycaemia (levels between 80-110 mg/dL)
Time frame: 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+
Time frame: Twelve days
Safety and tolerance
Values of GOT (between 5-50 U/L)
Time frame: Twelve days
Plan to share: No — Confidentiality
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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