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The purpose of this study is to determine the health effects of the 4 weeks daily intake of a drink manufactured from lupine protein hydrolysates in healthy volunteers. For that, blood markers of inflammation, oxidative stress, carbohydrate, lipid, protein and liver metabolism, together with general hematology and blood coagulation will be assessed at baseline time (day 0) and after drink ingestion (day +14 and +28).
The main objective of the present study is to verify the hypothesis that the intake of the drink based on lupine peptides is safe and has beneficial effects on the immune and oxidative status.
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drink manufactured from lupine peptides | Experimental | Beverage drink containing 0.5mg/ml of protein hydrolysate extracted from food grade lupine flour. The drink will be formulated as 200 mL tetra brik subjected to a test of microbiological safety according to the Spanish law (RD 135/2010 of 12 February 2010). The final beverage shall consist of:
The samples will guard and kept by the investigator until the day of delivery to the volunteers. The duration of treatment 4 weeks, during which the volunteers daily consume the contents of a tetra brik. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drink manufactured from lupine peptides | Dietary Supplement | Comparison of blood levels of immune, oxidative stress, biochemical markers and haemogram before and after (14, and 28 days) drinking the beverage. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the change from baseline of the plasma total antioxidant activity | Plasma total antioxidant activity | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma superoxide dismutase activity | Plasma superoxide dismutase activity | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma catalase activity | Plasma catalase activity | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma gluthathione peroxidase activity | Plasma gluthathione peroxidase activity | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma gluthathione reductase activity | Plasma gluthathione reductase activity | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of C reactive protein | Plasma levels of C reactive protein | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of immunoglobulins | plasma levels of immunoglobulin A, immunoglobulin E, immunoglobulin G and immunoglobulin M | day 0 (baseline), +14, +28, +42 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the change from baseline of the plasma levels of glucose | Plasma levels of glucose | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of haematological markers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Carrillo Vico, PhD | University of Seville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del RocÃo | Seville | 41013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24423513 | Background | Millan-Linares Mdel C, Yust Mdel M, Alcaide-Hidalgo JM, Millan F, Pedroche J. Lupine protein hydrolysates inhibit enzymes involved in the inflammatory pathway. Food Chem. 2014 May 15;151:141-7. doi: 10.1016/j.foodchem.2013.11.053. Epub 2013 Nov 19. | |
| 31732051 | Background | Cruz-Chamorro I, Alvarez-Sanchez N, Millan-Linares MDC, Yust MDM, Pedroche J, Millan F, Lardone PJ, Carrera-Sanchez C, Guerrero JM, Carrillo-Vico A. Lupine protein hydrolysates decrease the inflammatory response and improve the oxidative status in human peripheral lymphocytes. Food Res Int. 2019 Dec;126:108585. doi: 10.1016/j.foodres.2019.108585. Epub 2019 Jul 27. |
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| Assessment of the change from baseline of the plasma levels of complement | plasma levels of C3 and C4 | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the cytokines production in peripheral blood mononuclear cells | Supernatant levels of Interleukin (IL-1)beta, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12, IL-13, IL-17, IL-22, IFNgamma and Tumour necrosis factor (TNF)-alpha | day 0 (baseline), +14, +28, +42 |
Haemogram
| day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of homocysteine | Plasma levels of homocysteine | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of insulin | Plasma levels of insulin | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of triglycerides | Plasma levels of triglycerides | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of cholesterol | Plasma levels of cholesterol | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of Low Density Lipoprotein (LDL) cholesterol | Plasma levels of LDL cholesterol | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of High Density Lipoprotein (HDL) cholesterol | Plasma levels of HDL cholesterol | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of total proteins | Plasma levels of total proteins | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of urea | Plasma levels of urea | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of creatinine | Plasma levels of creatinine | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of alkaline phosphatase | Plasma levels of alkaline phosphatase | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of Alanine Aminotransferase (ALT) | Plasma levels of ALT | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of Aspartate Aminotransferase (AST) | plasma levels of AST | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the plasma levels of Gamma-Glutamyltransferase (GGT) | plasma levels of GGT | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the gene expression of antioxidant enzymes in peripheral blood mononuclear cells | Messenger Ribonucleic Acid (mRNA) expression of superoxide dismutase, Catalase, Gluthathione peroxidase, Gluthathione reductase and inducible nitric oxide synthase (iNOS) | day 0 (baseline), +14, +28, +42 |
| Assessment of the change from baseline of the Body Mass Index | Body Mass Index | day 0 (baseline), +14, +28, +42 |