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| ID | Type | Description | Link |
|---|---|---|---|
| PID2019-107650RB-C22 | Other Grant/Funding Number | Ministerio de Ciencia e Innovación (Spain) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunonutritional_1 | Active Comparator | Volunteers receive a commercial formulation as positive control of the effect |
|
| Immunonutritional_2 | Active Comparator | Patients receive a novel formulation to compare the effects in the level of biomarkers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of a commercial cookie formulation | Dietary Supplement | Volunteers received two cookies - 1st a commercial formulation and 2nd a novel formulation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMDEA Nutrition | Madrid | Madrid | 28049 | Spain |
Confidentiality
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| Immunonutritional_2 | Dietary Supplement | Volunteers receive two cookies - 1st a novel formulation and 2nd a commercial formulation |
|
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 |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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