NCT06595082

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Teramo · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lipid Disorder
• Systemic Inflammatory Response

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	4-week lupins in brine consumption	Volunteers were asked to consume lupins in brine for 4 weeks.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2024-04-18
• Primary completion: 2024-07-24
• Completion: 2024-07-24
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Italy