Status:
RECRUITING
Effects of Pulses Through the Gut Microbiome and Bioavailability of Bioactive Compounds
Lead Sponsor:
Paola Vitaglione
Conditions:
Lifestyle-related Condition
Eligibility:
All Genders
18-65 years
Phase:
NA
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 lifesty...
Detailed Description
Legumes are recognized for their distinctive nutritional profile, rich in plant-based proteins, low-glycemic-index carbohydrates, fiber, B vitamins, minerals, and polyphenols. Due to their protein con...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 16 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05999136
Start Date
January 10 2024
End Date
October 16 2024
Last Update
January 12 2024
Active Locations (1)
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1
Department of Agricultural Sciences, Federico II University
Portici, Italy, 80055