Evaluation of the Consumption of Lupins in Brine on Metabolic Markers in Healthy Individuals

NCT06595082 | Completed

• 1 other identifier: Superlupino
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipid Disorder; Systemic Inflammatory Response

Keywords

Lupins; Blood Lipids; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (12)

• Variation of anthropometric parameters

  4 weeks

• Variation of blood pressure parameters

  4 weeks

• Variation of blood glucose

  4 weeks

• Variation of blood insulin

  4 weeks

• Variation of C-peptide

  4 weeks

Study Arms (2)

30 grams Lupin

ACTIVE COMPARATOR

30 grams per week of lupins in brine

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.

Dietary Supplement: 4-week lupins in brine consumption and dietary suggestion

Interventions

4-week lupins in brine consumption DIETARY_SUPPLEMENT

Volunteers were asked to consume lupins in brine for 4 weeks.

30 grams Lupin

4-week lupins in brine consumption and dietary suggestion DIETARY_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.

600 grams Lupin and dietary suggestion

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• University of Teramo: lead

Study Sites (1)

University of Teramo

Teramo, 64100, Italy

Location

Related Publications (14)

• 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.

  PMID: 23902673 BACKGROUND

• 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.

  PMID: 24746974 BACKGROUND

• 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.

  PMID: 20938438 BACKGROUND

• 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.

  PMID: 35361281 BACKGROUND

• 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.

  PMID: 36152203 BACKGROUND

• 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.

  PMID: 32353681 BACKGROUND

• 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.

  PMID: 22810465 BACKGROUND

• 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.

  PMID: 30185958 BACKGROUND

• 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.

  PMID: 24915384 BACKGROUND

• 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.

  PMID: 23701571 BACKGROUND

• 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.

  PMID: 27757595 BACKGROUND

• 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.

  PMID: 30660336 BACKGROUND

• Serafini M, Jirillo E. Mangiare per prevenire. L'Immunonutrizione a tavola. 2015. Books & Company Editore.

  BACKGROUND

• Serafini M, Miglio C. Dietary plant products and human health. New evidences about the effects on degenerative diseases. 2011. Nova Science Publisher. NY

  BACKGROUND

MeSH Terms

Conditions

Lipid Metabolism Disorders; Inflammation

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mauro Serafini, PhD

  University of Teramo

  PRINCIPAL INVESTIGATOR

• Donato Angelino, PhD

  University of Teramo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: April 18, 2024
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data are available since the end of the intervention study for a 1-year time frame.
• Access Criteria: Contact to Principal Investigator

Locations

IT (1)