NCT05999136Completed
Effects of Pulses Through the Gut Microbiome and Bioavailability of Bioactive Compounds
Discovering the Effects of Pulses Through the Gut Microbiome and Bioavailability of Bioactive Compounds
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 13 Aug 2023
- Start date
- 10 Jan 2024
- Primary completion date
- 20 Dec 2024
- Lead sponsor
- Paola Vitaglione
- Diseases
- Obesity
- NCT number
- NCT05999136
What you commit to
- Study type: Interventional
- Participants enrolled: 84
- From 10 Jan 2024 to the primary completion date, 20 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Concurrent participation in other clinical trials.
Other illness
- Food allergies and intolerances, such as celiac disease, lactose intolerance, and others;
- Gastrointestinal disorders of any kind;
- Significant medical conditions;
- Hypertension (Blood pressure \> 140/90 mm Hg);
Lab values
- Hypertriglyceridemia (Triglycerides \> 200 mg/dL);
- Hypercholesterolemia (Cholesterol \> 200 mg/dL);
- Diabetes (Blood glucose ≥ 126 mg/dL);
Other
- Pregnancy or breastfeeding;
- Regular diet rich in fruits and vegetables;
- Consumption of alcohol equivalent to or exceeding 3 glasses of wine per day;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Agricultural Sciences, Federico II University Coordinator of this site? Confirm its status | Portici | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.