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

Clinical Study to Assess the Immunomodulatory and Antioxidant Effects of a Beverage Manufactured From Lupine Protein Hydrolysates in Healthy Volunteers

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).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Drink manufactured from lupine peptides

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41013
    • Hospital Universitario Virgen Del Rocio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Dietary supplement: Drink 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Seville
• Investigators: Principal Investigator: Antonio Carrillo Vico, PhD, University of Seville

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Lupine-1