Evaluation of the Consumption of Lupins in Brine on Metabolic Markers in Healthy Individuals
NCT ID: NCT06595082
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2024-04-18
2024-07-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of a Drink Containing Lupine Protein Hydrolysates on the Immune, Oxidative and Metabolic Status
NCT02590887
The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women
NCT01188902
Inulin,SCFA Production and Metabolic Response
NCT02009670
Bergamot and Cardio-Metabolic Risk Factors
NCT02205567
Postprandial Effect of Olive Leaf Biscuits and Tea Consumption on Blood Biomarkers in Healthy Individuals
NCT06983145
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
30 grams Lupin
30 grams per week of lupins in brine
4-week lupins in brine consumption
Volunteers were asked to consume lupins in brine for 4 weeks.
600 grams Lupin and dietary suggestion
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.
4-week lupins in brine consumption and dietary suggestion
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
4-week lupins in brine consumption
Volunteers were asked to consume lupins in brine for 4 weeks.
4-week lupins in brine consumption and dietary suggestion
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Omnivorous diet;
* Consumption of more than 6 servings of meat, processed meat and/or cheese;
Exclusion Criteria
* Chronic diseases
* Surgeries
* Dieting
* Pregnant or lactating
25 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Teramo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mauro Serafini
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mauro Serafini, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Teramo
Donato Angelino, PhD
Role: STUDY_DIRECTOR
University of Teramo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Teramo
Teramo, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Bahr 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.
Belski 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.
D'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.
D'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.
Fanti 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.
Miglio 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.
Partridge 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.
Peluso 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.
Peluso 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.
Ruscica 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.
Willett 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.
Serafini 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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Superlupino
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.