Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID07553936

Circular and Inclusive Use of Alternative Proteins in Mediterranean Supply Chains (CIPROMED)

Led by University of Bologna · Updated on 2026-05-04

40

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

U

University of Bologna

Lead Sponsor

I

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of foods enriched with alternative protein sources such as edible insects, microalgae, hemp, and legumes on appetite control, satiety, food preferences, and metabolic health in healthy adults and individuals with overweight. This study is part of the CIPROMED project, which aims to promote sustainable and circular food systems in the Mediterranean region. The trial includes both acute and chronic phases to assess short-term and longer-term impacts of these protein sources. In the acute phase, participants consume different protein-enriched breads in a randomized crossover design during five test sessions over five weeks. Products include breads with insect protein, microalgae, hemp, legumes, and a wheat-based control bread, all matched for energy content. The chronic phase involves following Mediterranean diets with assigned protein sources, including insect protein bread, seaweed-based burgers, or control foods, each consumed five times per week for two-month periods in a randomized order. Participants undergo assessments of satiety, hunger, food preferences, cravings, and energy intake using validated scales during the acute phase. In the chronic phase, metabolic parameters like blood glucose, insulin, cholesterol, gastrointestinal symptoms, liver fat, gut microbiota, and mood are measured at baseline, two months, and four months. Safety and tolerance are monitored throughout, with a total involvement lasting approximately four months.

CONDITIONS

Brief Title

Sustainable and Inclusive Use of Alternative Proteins in Mediterranean Supply Chains (CIPROMED)

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Providing signed informed consent
  • Being between 18 and 65 years of age
  • Having a body mass index (BMI) between 18.5 and 24.9 kg/m² (normal range) or between 25.0 and 34.9 kg/m² (overweight or class I obesity)
Not Eligible

You will not qualify if you...

  • Having a documented allergy to legumes, insects, microalgae, shellfish, mollusks, crustaceans, snails, insect venom, house dust mites, or any ingredient in the study foods
  • Having a confirmed or suspected diagnosis of Celiac Disease
  • History of severe allergic reactions to any allergen
  • Being pregnant or breastfeeding

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Test Sessions

Duration - 5 weeks

Participants attend five test sessions over five consecutive weeks, consuming different protein-enriched foods in a randomized order and undergoing assessments of appetite, satiety, food preferences, and energy intake.

5 visits (in-person, weekly)

Chronic Intervention Periods

Duration - Approximately 4 months total (two 2-month periods)

Participants follow Mediterranean diets including specific protein-enriched foods or control products in two successive intervention periods, each lasting approximately 2 months, according to randomized sequence assignments.

Visits at baseline, 2 months, and 4 months for assessments

Trial Site Locations

Total: 1 location

1

University of Bologna, Department of Medical and Surgical Sciences

Bologna, BO, Italy, 40138

Actively Recruiting

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Research Team

M

Maria Letizia Petroni, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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