Healthy Volunteers, Healthy Volunteers - Male and Female, Immunological Status
Conditions
Keywords
Immunonutrition, innate lymphoid cells, monocytes, triglycerides, insulin, HDL, Apo_A
Brief 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.
Interventions
DIETARY_SUPPLEMENTAdministration of a commercial cookie formulation
Volunteers received two cookies - 1st a commercial formulation and 2nd a novel formulation
DIETARY_SUPPLEMENTImmunonutritional_2
Volunteers receive two cookies - 1st a novel formulation and 2nd a commercial formulation
Sponsors
IMDEA Food
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood levels of triglycerides | Twelve days | Influence of the formulation(s) to preserve the peripheral physiological level of triglycerides (below 150 mg/dL) |
| Blood levels of cholesterol_LDL | Twelve days | Influence of the formulation(s) to preserve the peripheral physiological levels of Cholesterol\_LDL (below 100 mg/dL) |
| Blood levels of insulin | Twelve days | Influence of the formulations to preserve the peripheral physiological level of insulin (fasting insulin between 2.6 - 24.9 µIU/mL) |
| Blood levels of cholesterol_HDL | Twelve days | Influence of the formulation(s) to preserve the peripheral physiological levels of Cholesterol\_HDL (between 40-60 mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral blood monocytes | Twelve days | Impact of the formulation in the proportion (% relative to the total CD45+ population) of peripheral monocytes with a phenotype CD45+CD33+CX3CR1+ |
| Safety and tolerance | Twelve days | Values of GPT (between 5-37 U/L) |
| Antropometry | Twelve days | Parameters as 'body weight' (kilograms) and height (meters) will be aggregated to calculate the 'body mass index (BMI)' (kg/m\^2) |
| Blood levels of glucose | Twelve days | Impact of the formulation(s) in the fasting glycaemia (levels between 80-110 mg/dL) |
| Blood concentration of innate lymphoid cell precursors | 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+ |
Countries
Spain
Outcome results
None listed