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

University of Seville

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Drink manufactured from lupine peptides

Study type: Interventional

Funder types: Other

Identifiers

NCT02590887

Lupine-1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

drink manufactured from lupine peptides

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Drink manufactured from lupine peptides