Healthy VolunteersNCT02590887
Safety and Efficacy of a Drink Containing Lupine Protein Hydrolysates on the Immune, Oxidative and Metabolic Status
A study testing Drink manufactured from lupine peptides in people with Healthy Volunteers, run by University of Seville at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Drink manufactured from lupine peptides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Assess the Immunomodulatory and Antioxidant Effects of a Beverage Manufactured From Lupine Protein Hydrolysates in Healthy Volunteers
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).
Read the 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
- Being tested
- Drink manufactured from lupine peptides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drink manufactured from lupine peptidesDietary supplement
Comparison of blood levels of immune, oxidative stress, biochemical markers and haemogram before and after (14, and 28 days) drinking the beverage.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Drink manufactured from lupine peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the change from baseline of the plasma total antioxidant activity
Plasma total antioxidant activity
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma superoxide dismutase activity
Plasma superoxide dismutase activity
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma catalase activity
Plasma catalase activity
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma gluthathione peroxidase activity
Plasma gluthathione peroxidase activity
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma gluthathione reductase activity
Plasma gluthathione reductase activity
Measured: 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
Measured: 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
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of complement
plasma levels of C3 and C4
Measured: 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
Measured: day 0 (baseline), +14, +28, +42
Secondary outcomes (17)
Assessment of the change from baseline of the plasma levels of glucose
Plasma levels of glucose
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of haematological markers
Haemogram
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of homocysteine
Plasma levels of homocysteine
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of insulin
Plasma levels of insulin
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of triglycerides
Plasma levels of triglycerides
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of cholesterol
Plasma levels of cholesterol
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of Low Density Lipoprotein (LDL) cholesterol
Plasma levels of LDL cholesterol
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of High Density Lipoprotein (HDL) cholesterol
Plasma levels of HDL cholesterol
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of total proteins
Plasma levels of total proteins
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of urea
Plasma levels of urea
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of creatinine
Plasma levels of creatinine
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of alkaline phosphatase
Plasma levels of alkaline phosphatase
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of Alanine Aminotransferase (ALT)
Plasma levels of ALT
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of Aspartate Aminotransferase (AST)
plasma levels of AST
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of Gamma-Glutamyltransferase (GGT)
plasma levels of GGT
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the gene expression of antioxidant enzymes in peripheral blood mononuclear cells
Messenger Ribonucleic Acid (mRNA) expression of superoxide dismutase, Catalase, Gluthathione peroxidase, Gluthathione reductase and inducible nitric oxide synthase (iNOS)
Measured: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the Body Mass Index
Body Mass Index
Measured: day 0 (baseline), +14, +28, +42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Carrillo Vico, University of Seville
- Investigators
- Antonio Carrillo Vico, PhD, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590887
- Sponsor's protocol ID
- Lupine-1
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2015
- Last updated
- 23 Oct 2020
- Results posted
- No
Publications
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.
PubMed 24423513Cruz-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.
PubMed 31732051
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess the Immunomodulatory and Antioxidant Effects of a Beverage Manufactured From Lupine Protein Hydrolysates in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02590887
- Acronym / sponsor ID
- Lupine-1
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| drink manufactured from lupine peptides | Experimental | Dietary Supplement: Drink manufactured from lupine peptidesBeverage 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- Pre-existing disease
- Treatment with anti-inflammatory, antipyretic or antibiotic drugs
- Smoker
- Harmful alcohol consumption according to World Health Organization standards
- Pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drink manufactured from lupine peptidesComparison of blood levels of immune, oxidative stress, biochemical markers and haemogram before and after (14, and 28 days) drinking the beverage. | Dietary supplement | drink manufactured from lupine peptides |
Primary outcome
Assessment of the change from baseline of the plasma total antioxidant activity
Time frame: day 0 (baseline), +14, +28, +42
Plasma total antioxidant activity
Assessment of the change from baseline of the plasma superoxide dismutase activity
Time frame: day 0 (baseline), +14, +28, +42
Plasma superoxide dismutase activity
Assessment of the change from baseline of the plasma catalase activity
Time frame: day 0 (baseline), +14, +28, +42
Plasma catalase activity
Assessment of the change from baseline of the plasma gluthathione peroxidase activity
Time frame: day 0 (baseline), +14, +28, +42
Plasma gluthathione peroxidase activity
Assessment of the change from baseline of the plasma gluthathione reductase activity
Time frame: day 0 (baseline), +14, +28, +42
Plasma gluthathione reductase activity
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
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
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
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
17 secondary outcomes
Assessment of the change from baseline of the plasma levels of glucose
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of haematological markers
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of homocysteine
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of insulin
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of triglycerides
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of cholesterol
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of Low Density Lipoprotein (LDL) cholesterol
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of High Density Lipoprotein (HDL) cholesterol
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of total proteins
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of urea
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of creatinine
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of alkaline phosphatase
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of Alanine Aminotransferase (ALT)
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of Aspartate Aminotransferase (AST)
Time frame: day 0 (baseline), +14, +28, +42
Assessment of the change from baseline of the plasma levels of Gamma-Glutamyltransferase (GGT)
Time frame: day 0 (baseline), +14, +28, +42
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
Assessment of the change from baseline of the Body Mass Index
Time frame: day 0 (baseline), +14, +28, +42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Background: PubMed 24423513Millan-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.
- Background: PubMed 31732051Cruz-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.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Carrillo Vico, PhD principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drink manufactured from lupine peptides in people with Healthy Volunteers, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the change from baseline of the plasma total antioxidant activity (time frame: day 0 (baseline), +14, +28, +42). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590887, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.