Sustainable and inclusive alternative proteins for Mediterranean diets (CIPROMED)
Circular and Inclusive Use of Alternative Proteins in Mediterranean Supply Chains (CIPROMED)
This study tests whether breads and other Mediterranean foods made with alternative proteins (like cricket, spirulina, hemp, and legumes) change appetite, fullness, food choices, and metabolic markers in healthy adults and people who are overweight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Bologna Academic / other |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT07553936 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–65 with BMI between 18.5 and 34.9 kg/m² (normal weight through class I obesity) who can attend multiple clinic visits and consume the test products are ideal candidates.
Not a fit: People with documented allergies to insects, legumes, microalgae, shellfish, or related allergens, those with celiac disease, and pregnant or breastfeeding individuals are not eligible and would not be expected to benefit from participation.
Why it matters
Potential benefit: If successful, the project could identify sustainable alternative-protein foods that increase fullness, help reduce energy intake, and support healthier eating patterns in the Mediterranean population.
How similar studies have performed: Some short-term human studies show that certain alternative proteins can influence satiety and metabolic signals, but evidence specifically for edible insects and microalgae is limited and results are mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bologna, BO
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.