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

Not Applicable

Completed

• Conditions: Lipid Disorder; Systemic Inflammatory Response
• Interventions: Dietary Supplement: 4-week lupins in brine consumption; Dietary Supplement: 4-week lupins in brine consumption and dietary suggestion

• Registration Number: NCT06595082
• Lead Sponsor: University of Teramo

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.

Study Timeline

• Study Start: 2024-04-18
• Primary Completion: 2024-07-24
• Study Completion: 2024-07-24
• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 grams Lupin	4-week lupins in brine consumption	30 grams per week of lupins in brine
600 grams Lupin and dietary suggestion	4-week lupins in brine consumption 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.

Primary Outcome Measures

Name	Time	Method
Variation of plasma lipids	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Variation of anthropometric parameters	4 weeks	Measure of body weight (kg), height (m), BMI (kg/m2) fat mass (kg), free fat mass (kg) before and after dietary intervention. Weight (in kilograms) and height (and in meters) will be combined to report BMI in kg/m\^2).; Statistical analysis of the secondary 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.
Variation of blood pressure parameters	4 weeks	Measure of blood pressure (mmHg).; Statistical analysis of the secondary 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.
Variation of blood glucose	4 weeks	Measure of blood glucose (mg/dL) before and after dietary intervention.; Statistical analysis of the secondary outcomes 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.
Variation of blood insulin	4 weeks	Measure of blood insulin (µUI/mL) before and after dietary intervention.; Statistical analysis of the secondary outcomes 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.
Variation of C-peptide	4 weeks	Measure of blood C-peptide (ng/mL) before and after dietary intervention.; Statistical analysis of the secondary outcomes 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.
Variation of blood lipid-related parameters	4 weeks	Measure of blood total (mg/dL), LDL- (mg/dL), HDL- (mg/dL) cholesterol before and after dietary intervention.; Statistical analysis of the secondary outcomes 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.
Variation of transaminase parameters	4 weeks	Measure of blood aspartate transaminase (AST, U/L), alanine transaminase (ALT, U/L), γ-glutamyltransferase (GGT, U/L )before and after dietary intervention.; Statistical analysis of the secondary outcomes 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.
Variation of inflammatory parameters	4 weeks	Measure of blood C-reactive protein (CRP, mg/dL) and uric acid (mg/dL) before and after dietary intervention.; Statistical analysis of the secondary outcomes 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.
Variation of citokine and interleukine parameters	4 weeks	Measure of blood interleukins (IL) IL-1β, IL-4, IL-6, IL-10, IL-17, IL-18, interferon-γ, tumor necrosis factor-α (pg/mL) before and after dietary intervention.; Statistical analysis of the secondary outcomes 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.
Variation of urinary inflammatory parameters	4 weeks	Measure of urinary 8-isoprotaglandin F2α (8-iso-PGF2α, ng/mL) before and after dietary intervention before and after dietary intervention.; Statistical analysis of the secondary outcomes 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.
Variation of genetic and epigenetic expression of inflammatory mediators parameters	4 weeks	Measure of DNA methylation on CpG sites from peripheral blood mononuclear cell (PBMC) cells (% on single site) and expression of miRNA on saliva samples (fold change over control) before and after dietary intervention.; Statistical analysis of the secondary outcomes 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.
Variation of gut microbiota profile parameters	4 weeks	Measure of fecal microbiota composition (colony-forming unit, CFU/g) and short chain fatty acids (SCFA) before and after dietary intervention.; Statistical analysis of the secondary outcomes 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.

Trial Locations

Locations (1)

University of Teramo; 🇮🇹 Teramo, Italy