Lipid DisorderSUPERLUPINONCT06595082
Evaluation of the Consumption of Lupins in Brine on Metabolic Markers in Healthy Individuals
A study testing 4-week lupins in brine consumption and 4-week lupins in brine consumption and dietary suggestion in people with Lipid Disorder and Systemic Inflammatory Response, run by University of Teramo at 1 site in Italy.
Trial summary
The aim of the project was the evaluation of the effects of the consumption of different amounts of lupins in brine on lipid, glucose, inflammatory, oxidative stress, gut microbiota profile and (epi)genetic markers in healthy volunteers, by means of a 4-week 2-arm parallel randomized controlled trial. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Disorder, Systemic Inflammatory Response
- What is being tested?
- 4-week lupins in brine consumption and 4-week lupins in brine consumption and dietary suggestion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 18 Apr 2024to 24 Jul 2024
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI included between 18.5 and 29.9 kg/m2;
- Omnivorous diet;
- Consumption of more than 6 servings of meat, processed meat and/or cheese;
Who cannot join
- Antibiotic treatment within 3 months prior the dietary intervention;
- Chronic diseases
- Surgeries
- Dieting
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the project was the evaluation of the effects of the consumption of different amounts of lupins in brine on lipid, glucose, inflammatory, oxidative stress, gut microbiota profile and (epi)genetic markers in healthy volunteers, by means of a 4-week 2-arm parallel randomized controlled trial.
Read the detailed description
Epidemiological and intervention studies confirm a tight relationship between lifestyle - and particularly dietary choices - and human health. Among the dietary patterns, it has been showed that the adherence to a plant-based diet, i.e. Mediterranean diet, may have a pivotal role in promoting a health longevity and counteracting cardiovascular, neurological and cancer-related diseases. In fact, the abundant consumption of fruit, vegetables, cereals and pulses leads to a high intake of vegetable proteins, unsaturated fatty acids, minerals, vitamins, fibre and bioactive compounds which may have anti-inflammatory, antioxidant, anti-atherosclerotic, hypocholesterolemic and antimicrobial activities. In particular, there is a growing interest for valorization of pulses, among which lupins represent a good alternative as healthy snack but also as serving to be used during the principal meal. Lupins are traditional legumes of the Mediterranean basin, and they represent a good source of bioactive peptides, soluble fibre and minerals. Different trials evaluated the health effects of the consumption lupin derived products in humans concluding that it may lead to a decrease of blood pressure, reduction of blood glucose, cholesterol, triglycerides and uric acid.
Nevertheless, there is still a lack of information regarding the effects of the consumption of whole lupins, and in particular in one of the most sold forms, as in brine.
In this parallel randomized controlled trial, 60 healthy volunteers were randomly allocated for a 4-week consumption of:
- Active comparator arm: 30 grams per week of lupins in brine;
- Experimental arm: 600 grams per week of lupins in brine and the suggestion of reduction of at least two servings per week of meat, processed meat and/or cheese;
At baseline and after 4 weeks of dietary intervention, subjects were visited in medical facility and asked to provide blood, urine, saliva, feces for the evaluation of:
- Anthropometric and blood pressure parameters;
- Blood lipid and carbohydrate profile;
- Blood transaminase parameters;
- Blood and urine inflammation markers;
- Leucocyte and saliva DNA genetic and epigenetic markers;
- Fecal profile of gut microbiota. In addition, volunteers filled in different questionnaires regarding their dietary habits, the physical activity and the gut healthiness.
- Conditions
- Lipid Disorder, Systemic Inflammatory Response
- Being tested
- 4-week lupins in brine consumption, 4-week lupins in brine consumption and dietary suggestion
- Keywords
- Lupins, Blood Lipids, Inflammation
- Medical subject headings
- Lipid Metabolism Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-week lupins in brine consumptionDietary supplement
Volunteers were asked to consume lupins in brine for 4 weeks.
4-week lupins in brine consumption and dietary suggestionDietary supplement
Volunteers were asked to consume lupins in brine for 4 weeks and refrain to two servings per week of meat or processed meat or cheese.
| Study group | Role | What they receive |
|---|---|---|
| 30 grams Lupin | Active comparator | 30 grams per week of lupins in brine Receives: Dietary Supplement: 4-week lupins in brine consumption |
| 600 grams Lupin and dietary suggestion | Experimental | 600 grams per week of lupins in brine and dietary suggestion of lowering of two servings per week among meat, processed meat and/or cheese. Receives: Dietary Supplement: 4-week lupins in brine consumption and dietary suggestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of plasma lipids
Measure of plasma concentrations (mg/dL) of triglycerides before and after dietary intervention.
Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 4 weeks
Secondary outcomes (12)
Variation of anthropometric parameters
Measure of body weight (kg), height (m), BMI (kg/m2) fat mass (kg), free fat mass (kg) before and after dietary intervention. Weight (in kilograms) and height (and in meters) will be combined to report BMI in kg/m^2).
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 4 weeks
Variation of blood pressure parameters
Measure of blood pressure (mmHg).
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 4 weeks
Variation of blood glucose
Measure of blood glucose (mg/dL) before and after dietary intervention.
Statistical analysis of the secondary outcomes was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 4 weeks
Variation of blood insulin
Measure of blood insulin (µUI/mL) before and after dietary intervention.
Statistical analysis of the secondary outcomes was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 4 weeks
Variation of C-peptide
Measure of blood C-peptide (ng/mL) before and after dietary intervention.
Statistical analysis of the secondary outcomes was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 4 weeks
Variation of blood lipid-related parameters
Measure of blood total (mg/dL), LDL- (mg/dL), HDL- (mg/dL) cholesterol before and after dietary intervention.
Statistical analysis of the secondary outcomes was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 4 weeks
Variation of transaminase parameters
Measure of blood aspartate transaminase (AST, U/L), alanine transaminase (ALT, U/L), γ-glutamyltransferase (GGT, U/L )before and after dietary intervention.
Statistical analysis of the secondary outcomes was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 4 weeks
Variation of inflammatory parameters
Measure of blood C-reactive protein (CRP, mg/dL) and uric acid (mg/dL) before and after dietary intervention.
Statistical analysis of the secondary outcomes was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 4 weeks
Variation of citokine and interleukine parameters
Measure of blood interleukins (IL) IL-1β, IL-4, IL-6, IL-10, IL-17, IL-18, interferon-γ, tumor necrosis factor-α (pg/mL) before and after dietary intervention.
Statistical analysis of the secondary outcomes was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 4 weeks
Variation of urinary inflammatory parameters
Measure of urinary 8-isoprotaglandin F2α (8-iso-PGF2α, ng/mL) before and after dietary intervention before and after dietary intervention.
Statistical analysis of the secondary outcomes was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 4 weeks
Variation of genetic and epigenetic expression of inflammatory mediators parameters
Measure of DNA methylation on CpG sites from peripheral blood mononuclear cell (PBMC) cells (% on single site) and expression of miRNA on saliva samples (fold change over control) before and after dietary intervention.
Statistical analysis of the secondary outcomes was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 4 weeks
Variation of gut microbiota profile parameters
Measure of fecal microbiota composition (colony-forming unit, CFU/g) and short chain fatty acids (SCFA) before and after dietary intervention.
Statistical analysis of the secondary outcomes was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Apr 2024
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Lipid DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Teramo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Serafini, University of Teramo
- Investigators
- Mauro Serafini, PhD, Principal investigator, University of TeramoDonato Angelino, PhD, Study director, University of Teramo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595082
- Sponsor's protocol ID
- Superlupino
- Acronym
- SUPERLUPINO
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and datasets analysed during the current study are available from the Principal Investigator on reasonable request prior email contact.
Publications
Bahr M, Fechner A, Kramer J, Kiehntopf M, Jahreis G. Lupin protein positively affects plasma LDL cholesterol and LDL:HDL cholesterol ratio in hypercholesterolemic adults after four weeks of supplementation: a randomized, controlled crossover study. Nutr J. 2013 Aug 1;12:107. doi: 10.1186/1475-2891-12-107.
PubMed 23902673Bahr M, Fechner A, Kiehntopf M, Jahreis G. Consuming a mixed diet enriched with lupin protein beneficially affects plasma lipids in hypercholesterolemic subjects: a randomized controlled trial. Clin Nutr. 2015 Feb;34(1):7-14. doi: 10.1016/j.clnu.2014.03.008. Epub 2014 Apr 1.
PubMed 24746974Belski R, Mori TA, Puddey IB, Sipsas S, Woodman RJ, Ackland TR, Beilin LJ, Dove ER, Carlyon NB, Jayaseena V, Hodgson JM. Effects of lupin-enriched foods on body composition and cardiovascular disease risk factors: a 12-month randomized controlled weight loss trial. Int J Obes (Lond). 2011 Jun;35(6):810-9. doi: 10.1038/ijo.2010.213. Epub 2010 Oct 12.
PubMed 20938438D'Addario C, Pucci M, Bellia F, Girella A, Sabatucci A, Fanti F, Vismara M, Benatti B, Ferrara L, Fasciana F, Celebre L, Vigano C, Elli L, Sergi M, Maccarrone M, Buzzelli V, Trezza V, Dell'Osso B. Regulation of oxytocin receptor gene expression in obsessive-compulsive disorder: a possible role for the microbiota-host epigenetic axis. Clin Epigenetics. 2022 Mar 31;14(1):47. doi: 10.1186/s13148-022-01264-0.
PubMed 35361281D'Addario C, Pucci M. DNA Methylation Analysis of Cnr1 Gene Promoter. Methods Mol Biol. 2023;2576:373-384. doi: 10.1007/978-1-0716-2728-0_31.
PubMed 36152203Fanti F, Vincenti F, Montesano C, Serafini M, Compagnone D, Sergi M. dLLME-muSPE extraction coupled to HPLC-ESI-MS/MS for the determination of F2alpha-IsoPs in human urine. J Pharm Biomed Anal. 2020 Jul 15;186:113302. doi: 10.1016/j.jpba.2020.113302. Epub 2020 Apr 17.
PubMed 32353681Miglio C, Peluso I, Raguzzini A, Villano DV, Cesqui E, Catasta G, Toti E, Serafini M. Antioxidant and inflammatory response following high-fat meal consumption in overweight subjects. Eur J Nutr. 2013 Apr;52(3):1107-14. doi: 10.1007/s00394-012-0420-7. Epub 2012 Jul 19.
PubMed 22810465Partridge L, Deelen J, Slagboom PE. Facing up to the global challenges of ageing. Nature. 2018 Sep;561(7721):45-56. doi: 10.1038/s41586-018-0457-8. Epub 2018 Sep 5.
PubMed 30185958Peluso I, Miglio C, Morabito G, Ioannone F, Serafini M. Flavonoids and immune function in human: a systematic review. Crit Rev Food Sci Nutr. 2015;55(3):383-95. doi: 10.1080/10408398.2012.656770.
PubMed 24915384Peluso I, Villano DV, Roberts SA, Cesqui E, Raguzzini A, Borges G, Crozier A, Catasta G, Toti E, Serafini M. Consumption of mixed fruit-juice drink and vitamin C reduces postprandial stress induced by a high fat meal in healthy overweight subjects. Curr Pharm Des. 2014;20(6):1020-4. doi: 10.2174/138161282006140220144802.
PubMed 23701571Ruscica M, Pavanello C, Gandini S, Gomaraschi M, Vitali C, Macchi C, Morlotti B, Aiello G, Bosisio R, Calabresi L, Arnoldi A, Sirtori CR, Magni P. Effect of soy on metabolic syndrome and cardiovascular risk factors: a randomized controlled trial. Eur J Nutr. 2018 Mar;57(2):499-511. doi: 10.1007/s00394-016-1333-7. Epub 2016 Oct 18.
PubMed 27757595Willett W, Rockstrom J, Loken B, Springmann M, Lang T, Vermeulen S, Garnett T, Tilman D, DeClerck F, Wood A, Jonell M, Clark M, Gordon LJ, Fanzo J, Hawkes C, Zurayk R, Rivera JA, De Vries W, Majele Sibanda L, Afshin A, Chaudhary A, Herrero M, Agustina R, Branca F, Lartey A, Fan S, Crona B, Fox E, Bignet V, Troell M, Lindahl T, Singh S, Cornell SE, Srinath Reddy K, Narain S, Nishtar S, Murray CJL. Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems. Lancet. 2019 Feb 2;393(10170):447-492. doi: 10.1016/S0140-6736(18)31788-4. Epub 2019 Jan 16. No abstract available.
PubMed 30660336Serafini M, Jirillo E. Mangiare per prevenire. L'Immunonutrizione a tavola. 2015. Books & Company Editore.
Serafini M, Miglio C. Dietary plant products and human health. New evidences about the effects on degenerative diseases. 2011. Nova Science Publisher. NY
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Consumption of Lupins in Brine on Metabolic Markers in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06595082
- Acronym / sponsor ID
- SUPERLUPINO / Superlupino
- Conditions
- Lipid Disorder, Systemic Inflammatory Response
- Keywords
- Lupins, Blood Lipids, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of TeramoUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- 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 aim of the project was the evaluation of the effects of the consumption of different amounts of lupins in brine on lipid, glucose, inflammatory, oxidative stress, gut microbiota profile and (epi)genetic markers in healthy volunteers, by means of a 4-week 2-arm parallel randomized controlled trial.
Detailed description
Epidemiological and intervention studies confirm a tight relationship between lifestyle - and particularly dietary choices - and human health. Among the dietary patterns, it has been showed that the adherence to a plant-based diet, i.e. Mediterranean diet, may have a pivotal role in promoting a health longevity and counteracting cardiovascular, neurological and cancer-related diseases. In fact, the abundant consumption of fruit, vegetables, cereals and pulses leads to a high intake of vegetable proteins, unsaturated fatty acids, minerals, vitamins, fibre and bioactive compounds which may have anti-inflammatory, antioxidant, anti-atherosclerotic, hypocholesterolemic and antimicrobial activities. In particular, there is a growing interest for valorization of pulses, among which lupins represent a good alternative as healthy snack but also as serving to be used during the principal meal. Lupins are traditional legumes of the Mediterranean basin, and they represent a good source of bioactive peptides, soluble fibre and minerals. Different trials evaluated the health effects of the consumption lupin derived products in humans concluding that it may lead to a decrease of blood pressure, reduction of blood glucose, cholesterol, triglycerides and uric acid.
Nevertheless, there is still a lack of information regarding the effects of the consumption of whole lupins, and in particular in one of the most sold forms, as in brine.
In this parallel randomized controlled trial, 60 healthy volunteers were randomly allocated for a 4-week consumption of:
- Active comparator arm: 30 grams per week of lupins in brine;
- Experimental arm: 600 grams per week of lupins in brine and the suggestion of reduction of at least two servings per week of meat, processed meat and/or cheese;
At baseline and after 4 weeks of dietary intervention, subjects were visited in medical facility and asked to provide blood, urine, saliva, feces for the evaluation of:
- Anthropometric and blood pressure parameters;
- Blood lipid and carbohydrate profile;
- Blood transaminase parameters;
- Blood and urine inflammation markers;
- Leucocyte and saliva DNA genetic and epigenetic markers;
- Fecal profile of gut microbiota. In addition, volunteers filled in different questionnaires regarding their dietary habits, the physical activity and the gut healthiness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 grams Lupin | Active comparator | Dietary Supplement: 4-week lupins in brine consumption30 grams per week of lupins in brine |
| 600 grams Lupin and dietary suggestion | Experimental | Dietary Supplement: 4-week lupins in brine consumption and dietary suggestion600 grams per week of lupins in brine and dietary suggestion of lowering of two servings per week among meat, processed meat and/or cheese. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI included between 18.5 and 29.9 kg/m2;
- Omnivorous diet;
- Consumption of more than 6 servings of meat, processed meat and/or cheese;
Key exclusion criteria (5 listed)
- Antibiotic treatment within 3 months prior the dietary intervention;
- Chronic diseases
- Surgeries
- Dieting
- Pregnant or lactating
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 |
|---|---|---|
| 4-week lupins in brine consumptionVolunteers were asked to consume lupins in brine for 4 weeks. | Dietary supplement | 30 grams Lupin |
| 4-week lupins in brine consumption and dietary suggestionVolunteers were asked to consume lupins in brine for 4 weeks and refrain to two servings per week of meat or processed meat or cheese. | Dietary supplement | 600 grams Lupin and dietary suggestion |
Primary outcome
Variation of plasma lipids
Time frame: 4 weeks
Measure of plasma concentrations (mg/dL) of triglycerides before and after dietary intervention. Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
12 secondary outcomes
Variation of anthropometric parameters
Time frame: 4 weeks
Variation of blood pressure parameters
Time frame: 4 weeks
Variation of blood glucose
Time frame: 4 weeks
Variation of blood insulin
Time frame: 4 weeks
Variation of C-peptide
Time frame: 4 weeks
Variation of blood lipid-related parameters
Time frame: 4 weeks
Variation of transaminase parameters
Time frame: 4 weeks
Variation of inflammatory parameters
Time frame: 4 weeks
Variation of citokine and interleukine parameters
Time frame: 4 weeks
Variation of urinary inflammatory parameters
Time frame: 4 weeks
Variation of genetic and epigenetic expression of inflammatory mediators parameters
Time frame: 4 weeks
Variation of gut microbiota profile parameters
Time frame: 4 weeks
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 19 Sep 2024.
- Background: PubMed 23902673Bahr M, Fechner A, Kramer J, Kiehntopf M, Jahreis G. Lupin protein positively affects plasma LDL cholesterol and LDL:HDL cholesterol ratio in hypercholesterolemic adults after four weeks of supplementation: a randomized, controlled crossover study. Nutr J. 2013 Aug 1;12:107. doi: 10.1186/1475-2891-12-107.
- Background: PubMed 24746974Bahr M, Fechner A, Kiehntopf M, Jahreis G. Consuming a mixed diet enriched with lupin protein beneficially affects plasma lipids in hypercholesterolemic subjects: a randomized controlled trial. Clin Nutr. 2015 Feb;34(1):7-14. doi: 10.1016/j.clnu.2014.03.008. Epub 2014 Apr 1.
- Background: PubMed 20938438Belski R, Mori TA, Puddey IB, Sipsas S, Woodman RJ, Ackland TR, Beilin LJ, Dove ER, Carlyon NB, Jayaseena V, Hodgson JM. Effects of lupin-enriched foods on body composition and cardiovascular disease risk factors: a 12-month randomized controlled weight loss trial. Int J Obes (Lond). 2011 Jun;35(6):810-9. doi: 10.1038/ijo.2010.213. Epub 2010 Oct 12.
- Background: PubMed 35361281D'Addario C, Pucci M, Bellia F, Girella A, Sabatucci A, Fanti F, Vismara M, Benatti B, Ferrara L, Fasciana F, Celebre L, Vigano C, Elli L, Sergi M, Maccarrone M, Buzzelli V, Trezza V, Dell'Osso B. Regulation of oxytocin receptor gene expression in obsessive-compulsive disorder: a possible role for the microbiota-host epigenetic axis. Clin Epigenetics. 2022 Mar 31;14(1):47. doi: 10.1186/s13148-022-01264-0.
- Background: PubMed 36152203D'Addario C, Pucci M. DNA Methylation Analysis of Cnr1 Gene Promoter. Methods Mol Biol. 2023;2576:373-384. doi: 10.1007/978-1-0716-2728-0_31.
- Background: PubMed 32353681Fanti F, Vincenti F, Montesano C, Serafini M, Compagnone D, Sergi M. dLLME-muSPE extraction coupled to HPLC-ESI-MS/MS for the determination of F2alpha-IsoPs in human urine. J Pharm Biomed Anal. 2020 Jul 15;186:113302. doi: 10.1016/j.jpba.2020.113302. Epub 2020 Apr 17.
- Background: PubMed 22810465Miglio C, Peluso I, Raguzzini A, Villano DV, Cesqui E, Catasta G, Toti E, Serafini M. Antioxidant and inflammatory response following high-fat meal consumption in overweight subjects. Eur J Nutr. 2013 Apr;52(3):1107-14. doi: 10.1007/s00394-012-0420-7. Epub 2012 Jul 19.
- Background: PubMed 30185958Partridge L, Deelen J, Slagboom PE. Facing up to the global challenges of ageing. Nature. 2018 Sep;561(7721):45-56. doi: 10.1038/s41586-018-0457-8. Epub 2018 Sep 5.
- Background: PubMed 24915384Peluso I, Miglio C, Morabito G, Ioannone F, Serafini M. Flavonoids and immune function in human: a systematic review. Crit Rev Food Sci Nutr. 2015;55(3):383-95. doi: 10.1080/10408398.2012.656770.
- Background: PubMed 23701571Peluso I, Villano DV, Roberts SA, Cesqui E, Raguzzini A, Borges G, Crozier A, Catasta G, Toti E, Serafini M. Consumption of mixed fruit-juice drink and vitamin C reduces postprandial stress induced by a high fat meal in healthy overweight subjects. Curr Pharm Des. 2014;20(6):1020-4. doi: 10.2174/138161282006140220144802.
- Background: PubMed 27757595Ruscica M, Pavanello C, Gandini S, Gomaraschi M, Vitali C, Macchi C, Morlotti B, Aiello G, Bosisio R, Calabresi L, Arnoldi A, Sirtori CR, Magni P. Effect of soy on metabolic syndrome and cardiovascular risk factors: a randomized controlled trial. Eur J Nutr. 2018 Mar;57(2):499-511. doi: 10.1007/s00394-016-1333-7. Epub 2016 Oct 18.
- Background: PubMed 30660336Willett W, Rockstrom J, Loken B, Springmann M, Lang T, Vermeulen S, Garnett T, Tilman D, DeClerck F, Wood A, Jonell M, Clark M, Gordon LJ, Fanzo J, Hawkes C, Zurayk R, Rivera JA, De Vries W, Majele Sibanda L, Afshin A, Chaudhary A, Herrero M, Agustina R, Branca F, Lartey A, Fan S, Crona B, Fox E, Bignet V, Troell M, Lindahl T, Singh S, Cornell SE, Srinath Reddy K, Narain S, Nishtar S, Murray CJL. Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems. Lancet. 2019 Feb 2;393(10170):447-492. doi: 10.1016/S0140-6736(18)31788-4. Epub 2019 Jan 16. No abstract available.
- Individual participant dataSharing planned: Yes. The study protocol and datasets analysed during the current study are available from the Principal Investigator on reasonable request prior email contact.
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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.
Mauro Serafini, PhD principal investigator
University of Teramo
Donato Angelino, PhD study director
University of Teramo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-week lupins in brine consumption and 4-week lupins in brine consumption and dietary suggestion in people with Lipid Disorder and Systemic Inflammatory Response, run by University of Teramo at 1 site in Italy.
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 3 inclusion and 5 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 19 Sep 2024. 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 Italy. 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?
Variation of plasma lipids (time frame: 4 weeks). 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 NCT06595082, which also lists 14 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 19 Sep 2024.