Clinical trial NCT02590887: Safety and Efficacy of a Drink Containing Lupine Protein Hydrolysates on the Immune, Oxidative and Metabolic Status
Official title: Clinical Study to Assess the Immunomodulatory and Antioxidant Effects of a Beverage Manufactured From Lupine Protein Hydrolysates in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the change from baseline of the plasma total antioxidant activity
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma superoxide dismutase activity
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma catalase activity
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma gluthathione peroxidase activity
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma gluthathione reductase activity
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of C reactive protein
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of immunoglobulins
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of complement
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the cytokines production in peripheral blood mononuclear cells
timeFrame: day 0 (baseline), +14, +28, +42
Secondary outcomes:
measure: Assessment of the change from baseline of the plasma levels of glucose
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of haematological markers
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of homocysteine
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of insulin
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of triglycerides
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of cholesterol
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of Low Density Lipoprotein (LDL) cholesterol
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of High Density Lipoprotein (HDL) cholesterol
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of total proteins
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of urea
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of creatinine
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of alkaline phosphatase
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of Alanine Aminotransferase (ALT)
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of Aspartate Aminotransferase (AST)
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the plasma levels of Gamma-Glutamyltransferase (GGT)
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the gene expression of antioxidant enzymes in peripheral blood mononuclear cells
timeFrame: day 0 (baseline), +14, +28, +42
measure: Assessment of the change from baseline of the Body Mass Index
timeFrame: day 0 (baseline), +14, +28, +42
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: University of Seville
name: Antonio Carrillo Vico, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.