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

NCT02590887 | Completed

• 1 other identifier: Lupine-1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (17)

• Assessment of the change from baseline of the plasma levels of glucose

  day 0 (baseline), +14, +28, +42

• Assessment of the change from baseline of haematological markers

  day 0 (baseline), +14, +28, +42

• Assessment of the change from baseline of the plasma levels of homocysteine

  day 0 (baseline), +14, +28, +42

• Assessment of the change from baseline of the plasma levels of insulin

  day 0 (baseline), +14, +28, +42

• Assessment of the change from baseline of the plasma levels of triglycerides

  day 0 (baseline), +14, +28, +42

Study Arms (1)

drink manufactured from lupine peptides

EXPERIMENTAL

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

Interventions

Drink manufactured from lupine peptides DIETARY_SUPPLEMENT

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

drink manufactured from lupine peptides

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Related Publications (2)

• 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.

  PMID: 24423513 BACKGROUND

• 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.

  PMID: 31732051 BACKGROUND

Study Officials

• Antonio Carrillo Vico, PhD

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 29, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 23, 2020

Record last verified: 2020-10

Locations

ES (1)