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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590887
• Other study ID #: Lupine-1
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: October 2020
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocío	Seville

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Cruz-Chamorro I, Álvarez-Sánchez N, Millán-Linares MDC, Yust MDM, Pedroche J, Millán F, Lardone PJ, Carrera-Sánchez 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. — View Citation

Millán-Linares Mdel C, Yust Mdel M, Alcaide-Hidalgo JM, Millán 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the change from baseline of the plasma total antioxidant activity	Plasma total antioxidant activity	day 0 (baseline), +14, +28, +42
Primary	Assessment of the change from baseline of the plasma superoxide dismutase activity	Plasma superoxide dismutase activity	day 0 (baseline), +14, +28, +42
Primary	Assessment of the change from baseline of the plasma catalase activity	Plasma catalase activity	day 0 (baseline), +14, +28, +42
Primary	Assessment of the change from baseline of the plasma gluthathione peroxidase activity	Plasma gluthathione peroxidase activity	day 0 (baseline), +14, +28, +42
Primary	Assessment of the change from baseline of the plasma gluthathione reductase activity	Plasma gluthathione reductase activity	day 0 (baseline), +14, +28, +42
Primary	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
Primary	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
Primary	Assessment of the change from baseline of the plasma levels of complement	plasma levels of C3 and C4	day 0 (baseline), +14, +28, +42
Primary	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	Assessment of the change from baseline of the plasma levels of glucose	Plasma levels of glucose	day 0 (baseline), +14, +28, +42
Secondary	Assessment of the change from baseline of haematological markers	Haemogram	day 0 (baseline), +14, +28, +42
Secondary	Assessment of the change from baseline of the plasma levels of homocysteine	Plasma levels of homocysteine	day 0 (baseline), +14, +28, +42
Secondary	Assessment of the change from baseline of the plasma levels of insulin	Plasma levels of insulin	day 0 (baseline), +14, +28, +42
Secondary	Assessment of the change from baseline of the plasma levels of triglycerides	Plasma levels of triglycerides	day 0 (baseline), +14, +28, +42
Secondary	Assessment of the change from baseline of the plasma levels of cholesterol	Plasma levels of cholesterol	day 0 (baseline), +14, +28, +42
Secondary	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
Secondary	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
Secondary	Assessment of the change from baseline of the plasma levels of total proteins	Plasma levels of total proteins	day 0 (baseline), +14, +28, +42
Secondary	Assessment of the change from baseline of the plasma levels of urea	Plasma levels of urea	day 0 (baseline), +14, +28, +42
Secondary	Assessment of the change from baseline of the plasma levels of creatinine	Plasma levels of creatinine	day 0 (baseline), +14, +28, +42
Secondary	Assessment of the change from baseline of the plasma levels of alkaline phosphatase	Plasma levels of alkaline phosphatase	day 0 (baseline), +14, +28, +42
Secondary	Assessment of the change from baseline of the plasma levels of Alanine Aminotransferase (ALT)	Plasma levels of ALT	day 0 (baseline), +14, +28, +42
Secondary	Assessment of the change from baseline of the plasma levels of Aspartate Aminotransferase (AST)	plasma levels of AST	day 0 (baseline), +14, +28, +42
Secondary	Assessment of the change from baseline of the plasma levels of Gamma-Glutamyltransferase (GGT)	plasma levels of GGT	day 0 (baseline), +14, +28, +42
Secondary	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
Secondary	Assessment of the change from baseline of the Body Mass Index	Body Mass Index	day 0 (baseline), +14, +28, +42