Dietary Intervention With Probiotic Pasta and Evaluation of the Effects on Metabolic and Inflamma… (NCT04962633) | Clinical Trial Compass
CompletedNot Applicable
Dietary Intervention With Probiotic Pasta and Evaluation of the Effects on Metabolic and Inflammatory Status
Italy40 participantsStarted 2022-01-01
Plain-language summary
This study aims to investigate the effects of daily consumption for 4 weeks of a probiotic durum wheat pasta vs a conventional durum wheat pasta without probiotics on fasting metabolic parameters and inflammatory status, on gut permeability and functionality, on daily energy intakes, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences, blood pressure, body composition and wellbeing status in overweight and obese subjects.
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:
* healthy subjects;
* men and women;
* age 18-65 years;
* 25 kg/m2 ≤ BMI ≤ 35 kg/m2;
* habitual daily pasta consumption (≥ 1 portion/day);
* habitual diet characterized by absence of any food supplements and alternative medication, probiotics and prebiotics, whole grain and/or fiber enriched foods;
* intake of fruit/vegetables \< 3 servings/day;
* low level of physical activity (\< 500 metabolic equivalent min/week);
* signed written informed consent.
Exclusion Criteria:
* food allergies and intolerances and celiac disease;
* gastrointestinal diseases;
* relevant diseases;
* pregnant or breastfeeding;
* previous abdominal surgery;
* hypertriglyceridemia (Triglycerides \> 200 mg/dL);
* hypercholesterolemia (Total cholesterol \> 200 mg/dL);
* hyperglycaemia (glycaemia ≥ 110 mg/dL);
* hypertension (arterial blood pressure ≥140/90 mm Hg);
* weight loss ≥ 3 kg within 2 months before the study;
* antibiotics treatment within 3 months before the study;
* any medication (different from antibiotics) at the enrollment and within 2 months before the study;
* habitual diet characterized by high fruit and vegetables intakes (\>3 portion/die);
* high level of physical activity;
* Alcohol consumption ≥ 3 alcohol units per day;
* simultaneous participation in other trial.
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.