Effects of Pulses Through the Gut Microbiome and Bioavailability of Bioactive Compounds

NCT05999136 | Unknown DMC

• 1 other identifier: DE LEGUMINIBUS
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the effects of replacing red meat with pulses, on cardiometabolic health and gut microbiome in individuals with unhealthy habits and sedentary lifestyles at high risk for cardiovascular diseases. The main questions it aims to answer are:

• be assigned to either the Pulses Diet (PulD) group or the Plant Proteins Diet (PPD) group or the Habitual diet (HabD) group;
• follow their habitual diet (HabD) or the prescribed dietary plan designed on individual habitual diet to be isocaloric and isoprotein but replacing red meat with pulses (PulD group) or a combination of pulses and plant-based meat substitutes (PPD group);
• keep their physical activity levels unchanged during the entire intervention period;
• be required to complete 7-day food diaries and associated questionnaires on appetite, along with additional questionnaires related to physical activity levels, overall well-being, mood, sleep quality, stool frequency and consistency at each nutritional intervention time-point. Researchers will compare PulD, PPD, and HabD to assess if the dietary interventions have an impact on cardiometabolic health and gut microbiome.

Conditions

Lifestyle-related Condition

Keywords

Gut microbiome; Legumes; Pulses; Plant proteins; Cardiovascular diseases; Red meat substitution; Protein transition; Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• Changes in fasting total cholesterol concentration

  Measure of serum total cholesterol concentration (mg/dL serum)

  2 months

• Changes in plasma TMAO concentration

  Measure of plasma TMAO concentration (μmol/L plasma)

  2 months

Secondary Outcomes (43)

• Changes in faecal microbiome

  2 months

• Changes in urinary TMAO concentration

  2 months

• Changes in urinary polyphenols concentration

  2 months

• Changes in urinary urolithin concentration

  2 months

• Changes in urinary betaine concentration

  2 months

Study Arms (3)

Pulses Diet (PulD)

EXPERIMENTAL

Subjects will follow a Pulses-enriched diet for 2 months.

Other: Pulses diet

Plant Proteins Diet (PPD)

EXPERIMENTAL

Subjects will follow a Plant protein-enriched diet for 2 months.

Other: Plant proteins diet

Habitual Diet (HabD)

ACTIVE COMPARATOR

Subjects will follow a habitual diet for two months.

Other: Habitual diet

Interventions

Pulses diet OTHER

Subjects in the PulD group will be assigned a personalized diet prepared based on their own eating habits as established by 7-day food diary recalls. Energy values of habitual diets will be kept unchanged during the PulD intervention. The diet will be characterized by isocaloric and isoprotein substitutions, replacing habitual servings of red meat or processed meat with servings of pulses.

Pulses Diet (PulD)

Plant proteins diet OTHER

Subjects in the PPD group will be assigned a personalized diet prepared based on their own eating habits as established by 7-day food diary recalls. Energy values of habitual diets will be kept unchanged during the PPD intervention. The diet will be characterized by isocaloric and isoprotein substitutions, replacing habitual servings of red meat or processed meat with a mixture of pulses and plant-based meat substitutes.

Plant Proteins Diet (PPD)

Habitual diet OTHER

Control subjects will not change their habitual diet during intervention. All subjects will be requested not to change physical activity levels during the 8 week intervention period.

Habitual Diet (HabD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women aged 18-65;
• ≤ BMI ≤ 35 kg/m2;
• habitual diet characterized by ≥ 3 medium servings of fresh red meat or processed meat (equivalent to a portion weight of 100g of fresh meat and 50g of cured meats);
• habitual diet without probiotics, functional foods, and/or any type of food supplements;
• low level of physical activity (sedentary lifestyle);
• signing the informed consent form and expressing consent for the processing of personal data.

You may not qualify if:

• Food allergies and intolerances, such as celiac disease, lactose intolerance, and others;
• Gastrointestinal disorders of any kind;
• Significant medical conditions;
• Pregnancy or breastfeeding;
• Hypertriglyceridemia (Triglycerides \> 200 mg/dL);
• Hypercholesterolemia (Cholesterol \> 200 mg/dL);
• Diabetes (Blood glucose ≥ 126 mg/dL);
• Hypertension (Blood pressure \> 140/90 mm Hg);
• Weight loss ≥ 3 kg in the past 2 months prior to the study;
• Use of any medication at enrollment and in the 2 months prior to the study;
• Regular diet rich in fruits and vegetables;
• Consumption of alcohol equivalent to or exceeding 3 glasses of wine per day;
• Concurrent participation in other clinical trials.

Sponsors & Collaborators

• Paola Vitaglione: lead

Study Sites (1)

Department of Agricultural Sciences, Federico II University

Portici, 80055, Italy

RECRUITING

Related Publications (2)

• Crimarco A, Springfield S, Petlura C, Streaty T, Cunanan K, Lee J, Fielding-Singh P, Carter MM, Topf MA, Wastyk HC, Sonnenburg ED, Sonnenburg JL, Gardner CD. A randomized crossover trial on the effect of plant-based compared with animal-based meat on trimethylamine-N-oxide and cardiovascular disease risk factors in generally healthy adults: Study With Appetizing Plantfood-Meat Eating Alternative Trial (SWAP-MEAT). Am J Clin Nutr. 2020 Nov 11;112(5):1188-1199. doi: 10.1093/ajcn/nqaa203.

  PMID: 32780794 RESULT

• Meslier V, Laiola M, Roager HM, De Filippis F, Roume H, Quinquis B, Giacco R, Mennella I, Ferracane R, Pons N, Pasolli E, Rivellese A, Dragsted LO, Vitaglione P, Ehrlich SD, Ercolini D. Mediterranean diet intervention in overweight and obese subjects lowers plasma cholesterol and causes changes in the gut microbiome and metabolome independently of energy intake. Gut. 2020 Jul;69(7):1258-1268. doi: 10.1136/gutjnl-2019-320438. Epub 2020 Feb 19.

  PMID: 32075887 RESULT

MeSH Terms

Conditions

Mental Disorders; Cardiovascular Diseases; Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paola Vitaglione, Professor

  Department of Agricultural Sciences, Federico II University

  STUDY DIRECTOR

Central Study Contacts

Paola Vitaglione, Professor

CONTACT

+390812539357; paola.vitaglione@unina.it

Study Design

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

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 21, 2023
• Study Start: January 10, 2024
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will become available immediately after the publications of the results with no end date.
• Access Criteria: Metagenomic reads generated in this study will be available (without conditions of reuse) at the European Nucleotide Archive (ENA) in European Bioinformatics Institute (EBI), by using a specific accession number. The clinical data will be shared with any researcher who will ask the corresponding author by providing a methodologically sound proposal.

Locations

IT (1)