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

Plain-language summary

This study investigated the safety and effects of a drink made from lupine peptides on immune, oxidative, and metabolic status. It enrolled healthy volunteers aged 18-50 with a body mass index between 19 and 26 and no serious disease. It was conducted as a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

University of Seville

Intervention

Drink manufactured from lupine peptides

Start date

10/1/2015

Estimated completion

12/1/2015

Countries

Spain

Related genes

Locations

• Seville, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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