CompletedNot Applicable

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

Italy84 participantsStarted 2024-01-10

Plain-language 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: 1. How does the substitution of red meat with pulses affect some markers of cardiovascular risk? 2. How does this dietary intervention influence the composition and function of the gut microbiome, nutritional status, well-being indices, and biomarkers related to metabolic, oxidative, inflammatory, immune, and intestinal permeability status? Participants will: * 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * men and women aged 18-65; * 20 ≤ 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in fasting total cholesterol concentration

Timeframe: 2 months

Changes in plasma TMAO concentration

Timeframe: 2 months

Trial details

NCT IDNCT05999136

SponsorPaola Vitaglione

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-20

View on ClinicalTrials.gov More Lifestyle-related Condition trials