Safety and Efficacy of a Drink Containing Lupine Protein Hydrolysates on the Immune, Oxidative and Metabolic Status

University of Seville35 enrolled

Overview

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: * 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Drink manufactured from lupine peptidesDIETARY_SUPPLEMENT

Comparison of blood levels of immune, oxidative stress, biochemical markers and haemogram before and after (14, and 28 days) drinking the beverage.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitario Virgen del Rocío

Seville, Spain

Outcomes

Primary Outcomes

Assessment of the change from baseline of the plasma total antioxidant activity

Plasma total antioxidant activity

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma superoxide dismutase activity

Plasma superoxide dismutase activity

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma catalase activity

Plasma catalase activity

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma gluthathione peroxidase activity

Plasma gluthathione peroxidase activity

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma gluthathione reductase activity

Plasma gluthathione reductase activity

Time frame: 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

Time frame: 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

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma levels of complement

plasma levels of C3 and C4

Data from ClinicalTrials.gov

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Secondary Outcomes

Assessment of the change from baseline of the plasma levels of glucose

Plasma levels of glucose

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of haematological markers

Haemogram

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma levels of homocysteine

Plasma levels of homocysteine

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma levels of insulin

Plasma levels of insulin

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma levels of triglycerides

Plasma levels of triglycerides

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma levels of cholesterol

Plasma levels of cholesterol

Time frame: 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

Time frame: 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

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma levels of total proteins

Plasma levels of total proteins

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma levels of urea

Plasma levels of urea

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma levels of creatinine

Plasma levels of creatinine

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma levels of alkaline phosphatase

Plasma levels of alkaline phosphatase

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma levels of Alanine Aminotransferase (ALT)

Plasma levels of ALT

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma levels of Aspartate Aminotransferase (AST)

plasma levels of AST

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma levels of Gamma-Glutamyltransferase (GGT)

plasma levels of GGT

Time frame: 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)

Time frame: day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the Body Mass Index

Body Mass Index

Time frame: day 0 (baseline), +14, +28, +42