Healthy Volunteers
Conditions
Brief summary
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).
Detailed description
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: * Assess the effect of the drink on biological parameters of the carbohydrate, lipid, renal and hepatic metabolism as well as hematology analysis. * Assess whether the new product is well tolerated. * Evaluate the effect of the drink on the general health of the volunteers through the Short Form-36 health survey. * Determine the degree of drink acceptability through the acceptability Likert test.
Interventions
DIETARY_SUPPLEMENTDrink manufactured from lupine peptides
Comparison of blood levels of immune, oxidative stress, biochemical markers and haemogram before and after (14, and 28 days) drinking the beverage.
Sponsors
University of Seville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject between 18 and 50 years old * Body mass index between 19 and 26 kg/m2 * No severe disease * Biochemical markers within the normal range * No previous history of drug abuse * Negative serology for hepatitis C virus (HCV), hepatitis B virus (HBV) and HIV * Females must have a negative pregnancy test * The volunteer should signed the informed consent approved by the Ethics Committees of Clinical Trials
Exclusion criteria
* Pre-existing disease * Treatment with anti-inflammatory, antipyretic or antibiotic drugs * Smoker * Harmful alcohol consumption according to World Health Organization standards * Pregnant females * Hypersensitivity to lupine, corn or xanthan gum. * Allergies to plant derivatives and celiac. * Participation in another clinical trial. * Blood donation in the previous three months. * Any other circumstance that according to the research team may lead to increased risk for voluntary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the change from baseline of the plasma total antioxidant activity | day 0 (baseline), +14, +28, +42 | Plasma total antioxidant activity |
| Assessment of the change from baseline of the plasma superoxide dismutase activity | day 0 (baseline), +14, +28, +42 | Plasma superoxide dismutase activity |
| Assessment of the change from baseline of the plasma catalase activity | day 0 (baseline), +14, +28, +42 | Plasma catalase activity |
| Assessment of the change from baseline of the plasma gluthathione peroxidase activity | day 0 (baseline), +14, +28, +42 | Plasma gluthathione peroxidase activity |
| Assessment of the change from baseline of the plasma gluthathione reductase activity | day 0 (baseline), +14, +28, +42 | Plasma gluthathione reductase activity |
| Assessment of the change from baseline of the plasma levels of C reactive protein | day 0 (baseline), +14, +28, +42 | Plasma levels of C reactive protein |
| Assessment of the change from baseline of the plasma levels of immunoglobulins | day 0 (baseline), +14, +28, +42 | plasma levels of immunoglobulin A, immunoglobulin E, immunoglobulin G and immunoglobulin M |
| Assessment of the change from baseline of the plasma levels of complement | day 0 (baseline), +14, +28, +42 | plasma levels of C3 and C4 |
| Assessment of the change from baseline of the cytokines production in peripheral blood mononuclear cells | day 0 (baseline), +14, +28, +42 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the change from baseline of the plasma levels of High Density Lipoprotein (HDL) cholesterol | day 0 (baseline), +14, +28, +42 | Plasma levels of HDL cholesterol |
| Assessment of the change from baseline of the plasma levels of total proteins | day 0 (baseline), +14, +28, +42 | Plasma levels of total proteins |
| Assessment of the change from baseline of the plasma levels of urea | day 0 (baseline), +14, +28, +42 | Plasma levels of urea |
| Assessment of the change from baseline of the plasma levels of Gamma-Glutamyltransferase (GGT) | day 0 (baseline), +14, +28, +42 | plasma levels of GGT |
| Assessment of the change from baseline of the plasma levels of Alanine Aminotransferase (ALT) | day 0 (baseline), +14, +28, +42 | Plasma levels of ALT |
| Assessment of the change from baseline of the plasma levels of alkaline phosphatase | day 0 (baseline), +14, +28, +42 | Plasma levels of alkaline phosphatase |
| Assessment of the change from baseline of the gene expression of antioxidant enzymes in peripheral blood mononuclear cells | day 0 (baseline), +14, +28, +42 | Messenger Ribonucleic Acid (mRNA) expression of superoxide dismutase, Catalase, Gluthathione peroxidase, Gluthathione reductase and inducible nitric oxide synthase (iNOS) |
| Assessment of the change from baseline of the Body Mass Index | day 0 (baseline), +14, +28, +42 | Body Mass Index |
| Assessment of the change from baseline of the plasma levels of creatinine | day 0 (baseline), +14, +28, +42 | Plasma levels of creatinine |
| Assessment of the change from baseline of the plasma levels of Aspartate Aminotransferase (AST) | day 0 (baseline), +14, +28, +42 | plasma levels of AST |
| Assessment of the change from baseline of the plasma levels of glucose | day 0 (baseline), +14, +28, +42 | Plasma levels of glucose |
| Assessment of the change from baseline of haematological markers | day 0 (baseline), +14, +28, +42 | Haemogram |
| Assessment of the change from baseline of the plasma levels of homocysteine | day 0 (baseline), +14, +28, +42 | Plasma levels of homocysteine |
| Assessment of the change from baseline of the plasma levels of insulin | day 0 (baseline), +14, +28, +42 | Plasma levels of insulin |
| Assessment of the change from baseline of the plasma levels of triglycerides | day 0 (baseline), +14, +28, +42 | Plasma levels of triglycerides |
| Assessment of the change from baseline of the plasma levels of cholesterol | day 0 (baseline), +14, +28, +42 | Plasma levels of cholesterol |
| Assessment of the change from baseline of the plasma levels of Low Density Lipoprotein (LDL) cholesterol | day 0 (baseline), +14, +28, +42 | Plasma levels of LDL cholesterol |
Countries
Spain
Outcome results
None listed