Clinical trial NCT06595082: Evaluation of the Consumption of Lupins in Brine on Metabolic Markers in Healthy Individuals
Official title: Evaluation of the Consumption of Lupins in Brine on Metabolic Markers in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Disorder
Systemic Inflammatory Response
Keywords: Lupins
Blood Lipids
Inflammation
Lead sponsor: University of Teramo
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* Antibiotic treatment within 3 months prior the dietary intervention;
* Chronic diseases
* Surgeries
* Dieting
* Pregnant or lactating

Primary outcomes:
measure: Variation of plasma lipids
timeFrame: 4 weeks
Secondary outcomes:
measure: Variation of anthropometric parameters
timeFrame: 4 weeks
measure: Variation of blood pressure parameters
timeFrame: 4 weeks
measure: Variation of blood glucose
timeFrame: 4 weeks
measure: Variation of blood insulin
timeFrame: 4 weeks
measure: Variation of C-peptide
timeFrame: 4 weeks
measure: Variation of blood lipid-related parameters
timeFrame: 4 weeks
measure: Variation of transaminase parameters
timeFrame: 4 weeks
measure: Variation of inflammatory parameters
timeFrame: 4 weeks
measure: Variation of citokine and interleukine parameters
timeFrame: 4 weeks
measure: Variation of urinary inflammatory parameters
timeFrame: 4 weeks
measure: Variation of genetic and epigenetic expression of inflammatory mediators parameters
timeFrame: 4 weeks
measure: Variation of gut microbiota profile parameters
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Teramo
country: Italy
facility: University of Teramo
Study officials:
affiliation: University of Teramo
name: Mauro Serafini, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Teramo
name: Donato Angelino, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Serafini M, Jirillo E. Mangiare per prevenire. L'Immunonutrizione a tavola. 2015. Books & Company Editore.
citation: Serafini M, Miglio C. Dietary plant products and human health. New evidences about the effects on degenerative diseases. 2011. Nova Science Publisher. NY