Safety and Efficacy of a Drink Containing Lupine Protein Hydrolysates on the Immune, Oxidative and Metabolic Status
- Conditions
- Healthy Volunteers
- Interventions
- Dietary Supplement: Drink manufactured from lupine peptides
- Registration Number
- NCT02590887
- Lead Sponsor
- University of Seville
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description drink manufactured from lupine peptides Drink manufactured from lupine peptides 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: * Oily phase: refined sunflower oil 5% w/w of the emulsion * Aqueous phase (water) 95% w/w of the emulsion, containing equal volumes of solution A and B: * Solution A: * Hydrolyzed Lupine (1.17% w/w) * Sucrose (14.03% w/w) * Vanilla flavor (0.42% w/w) * Drinking water (84.38% w/v) * Solution B: * Xanthan gum (0.28% w/w) * Drinking water (99.72% w/v) 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.
- Primary Outcome Measures
Name Time Method 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 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 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 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 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 Outcome Measures
Name Time Method 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 homocysteine day 0 (baseline), +14, +28, +42 Plasma levels of homocysteine
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
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 cholesterol day 0 (baseline), +14, +28, +42 Plasma levels of cholesterol
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 alkaline phosphatase day 0 (baseline), +14, +28, +42 Plasma levels of alkaline phosphatase
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 haematological markers day 0 (baseline), +14, +28, +42 Haemogram
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 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 creatinine day 0 (baseline), +14, +28, +42 Plasma levels of creatinine
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 plasma levels of glucose day 0 (baseline), +14, +28, +42 Plasma levels of glucose
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 Gamma-Glutamyltransferase (GGT) day 0 (baseline), +14, +28, +42 plasma levels of GGT
Assessment of the change from baseline of the Body Mass Index day 0 (baseline), +14, +28, +42 Body Mass Index
Trial Locations
- Locations (1)
Hospital Universitario Virgen del Rocío
🇪🇸Seville, Spain