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Completed

NCT Number: NCT06595082

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

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.

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Key information

Conditions

Lipid Disorder Inflammation Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Teramo

Teramo, 64100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4-week lupins in brine consumption

Dietary Supplement

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

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.

Primary outcomes

  1. Variation of plasma lipids

    Time frame: 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 outcomes

  1. Variation of anthropometric parameters

    Time frame: 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.

  2. Variation of blood pressure parameters

    Time frame: 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.

  3. Variation of blood glucose

    Time frame: 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.

  4. Variation of blood insulin

    Time frame: 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.

  5. Variation of C-peptide

    Time frame: 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.

  6. Variation of blood lipid-related parameters

    Time frame: 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.

  7. Variation of transaminase parameters

    Time frame: 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.

  8. Variation of inflammatory parameters

    Time frame: 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.

  9. Variation of citokine and interleukine parameters

    Time frame: 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.

  10. Variation of urinary inflammatory parameters

    Time frame: 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.

  11. Variation of genetic and epigenetic expression of inflammatory mediators parameters

    Time frame: 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.

  12. Variation of gut microbiota profile parameters

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Teramo

Other

Registry information

Acronym: SUPERLUPINO

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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