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Completed

NCT Number: NCT02590887

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

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).

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Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Assessment of the change from baseline of the plasma total antioxidant activity

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma total antioxidant activity

  2. Assessment of the change from baseline of the plasma superoxide dismutase activity

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma superoxide dismutase activity

  3. Assessment of the change from baseline of the plasma catalase activity

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma catalase activity

  4. Assessment of the change from baseline of the plasma gluthathione peroxidase activity

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma gluthathione peroxidase activity

  5. Assessment of the change from baseline of the plasma gluthathione reductase activity

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma gluthathione reductase activity

  6. Assessment of the change from baseline of the plasma levels of C reactive protein

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma levels of C reactive protein

  7. Assessment of the change from baseline of the plasma levels of immunoglobulins

    Time frame: day 0 (baseline), +14, +28, +42

    plasma levels of immunoglobulin A, immunoglobulin E, immunoglobulin G and immunoglobulin M

  8. Assessment of the change from baseline of the plasma levels of complement

    Time frame: day 0 (baseline), +14, +28, +42

    plasma levels of C3 and C4

  9. Assessment of the change from baseline of the cytokines production in peripheral blood mononuclear cells

    Time frame: day 0 (baseline), +14, +28, +42

    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

Secondary outcomes

  1. Assessment of the change from baseline of the plasma levels of glucose

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma levels of glucose

  2. Assessment of the change from baseline of haematological markers

    Time frame: day 0 (baseline), +14, +28, +42

    Haemogram

  3. Assessment of the change from baseline of the plasma levels of homocysteine

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma levels of homocysteine

  4. Assessment of the change from baseline of the plasma levels of insulin

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma levels of insulin

  5. Assessment of the change from baseline of the plasma levels of triglycerides

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma levels of triglycerides

  6. Assessment of the change from baseline of the plasma levels of cholesterol

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma levels of cholesterol

  7. Assessment of the change from baseline of the plasma levels of Low Density Lipoprotein (LDL) cholesterol

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma levels of LDL cholesterol

  8. Assessment of the change from baseline of the plasma levels of High Density Lipoprotein (HDL) cholesterol

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma levels of HDL cholesterol

  9. Assessment of the change from baseline of the plasma levels of total proteins

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma levels of total proteins

  10. Assessment of the change from baseline of the plasma levels of urea

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma levels of urea

  11. Assessment of the change from baseline of the plasma levels of creatinine

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma levels of creatinine

  12. Assessment of the change from baseline of the plasma levels of alkaline phosphatase

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma levels of alkaline phosphatase

  13. Assessment of the change from baseline of the plasma levels of Alanine Aminotransferase (ALT)

    Time frame: day 0 (baseline), +14, +28, +42

    Plasma levels of ALT

  14. Assessment of the change from baseline of the plasma levels of Aspartate Aminotransferase (AST)

    Time frame: day 0 (baseline), +14, +28, +42

    plasma levels of AST

  15. Assessment of the change from baseline of the plasma levels of Gamma-Glutamyltransferase (GGT)

    Time frame: day 0 (baseline), +14, +28, +42

    plasma levels of GGT

  16. Assessment of the change from baseline of the gene expression of antioxidant enzymes in peripheral blood mononuclear cells

    Time frame: day 0 (baseline), +14, +28, +42

    Messenger Ribonucleic Acid (mRNA) expression of superoxide dismutase, Catalase, Gluthathione peroxidase, Gluthathione reductase and inducible nitric oxide synthase (iNOS)

  17. Assessment of the change from baseline of the Body Mass Index

    Time frame: day 0 (baseline), +14, +28, +42

    Body Mass Index

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 29, 2015
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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