Sustainable and inclusive alternative proteins for Mediterranean diets (CIPROMED)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial uses an acute randomized crossover design in which participants attend five controlled test sessions to eat breads enriched with different alternative proteins (Acheta domesticus, spirulina, hemp, legumes) or a wheat control, with postprandial satiety, hunger, cravings, food preferences, and short-term energy intake measured after each session. Randomization follows a Latin square and is stratified by sex and weight status to allow within-subject comparisons and reduce confounding. A chronic phase applies structured Mediterranean-diet interventions incorporating prototype products (insect-enriched bread, seaweed-based burger, or control) over a longer period to observe sustained effects. Outcomes include subjective appetite measures, dietary intake, and metabolic markers to link short-term responses with longer-term eating behavior and health signals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Providing signed informed consent,
* Being between 18 and 65 years of age,
* Having a body mass index (BMI) within the normal range, defined as between 18.5 and 24.9 kg/m² or Having a body mass index (BMI) between 25.0 and 34.9 kg/m², inclusive, corresponding to the overweight category or, at most, class I obesity.

Exclusion Criteria:

* Positive and documented history of allergy to legumes, insects, microalgae, shellfish, mollusks, crustaceans, snails, insect venom, house dust mites, or any component (ingredient or additive) present in the food prototypes tested, or a confirmed or suspected diagnosis of Celiac Disease.
* History of severe allergic reactions to any type of allergen.
* Pregnancy or Breastfeeding

Where it's running

• University of Bologna, Department of Medical and Surgical Sciences
  Bologna, Bo, Italy Recruiting

Study contacts

• Principal investigator: Maria Letizia Petroni, Professor — University of Bologna
• Study coordinator: Maria Letizia Petroni, Professor
• Email: marialetizia.petroni@unibo.it
• Phone: 051/2143688

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.