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

University of Teramo

Status: Completed

Conditions: Lipid Disorder; Systemic Inflammatory Response

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06595082

Superlupino

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

30 grams Lupin

Active Comparator group

Description:

30 grams per week of lupins in brine

Treatment:

Dietary Supplement: 4-week lupins in brine consumption

600 grams Lupin and dietary suggestion

Experimental group

Description:

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.

Treatment:

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