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

NCT ID: NCT02590887

Last Updated: 2020-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Drink manufactured from lupine peptides

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Antonio Carrillo Vico

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Carrillo Vico, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Seville

Locations

Hospital Universitario Virgen del Rocío

Seville, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 24423513 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31732051 (View on PubMed)

Other Identifiers

Lupine-1

Identifier Type: -

Identifier Source: org_study_id