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

NCT07553936 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-04

No results posted yet for this study

Summary

This study investigates the effects of foods enriched with alternative protein sources, including edible insects, microalgae, hemp, and legumes, on appetite regulation, satiety, food preferences, and metabolic health in healthy adults and individuals with overweight. The study is part of the CIPROMED project, which aims to support sustainable and circular food systems in the Mediterranean area.

The study consists of two phases. In the acute phase, participants will consume different protein-enriched bread products in a controlled setting following a randomized crossover design. Each participant will be exposed to multiple test conditions, allowing within-subject comparisons of postprandial responses. Outcomes assessed during this phase include satiety, hunger, food preference, craving, and short-term energy intake, measured using validated scales and dietary assessment tools.

In the chronic phase, participants will follow structured dietary interventions over a longer period within a Mediterranean dietary framework. Participants will be assigned to different dietary patterns including alternative protein-based foods and control products. This phase aims to evaluate the effects of repeated consumption of alternative protein sources on metabolic parameters, gastrointestinal tolerance, nutritional status, and behavioral responses.

The study aims to assess the acceptability and physiological effects of alternative protein sources and to compare their impact with that of traditional protein sources commonly used in Mediterranean diets.

Conditions

  • Food Preferences
  • Satiety and Food Intake
  • Appetite Regulation
  • Overweight (BMI > 25)
  • Gut Microbiota

Interventions

OTHER

Mediterranean Diet with Control Products (chronic phase)

Mediterranean diet including control foods such as legume-based bread and standard fish burger, consumed five times per week for a period of 2 months.

OTHER

Mediterranean Diet with Insect Protein Bread (chronic phase)

Mediterranean diet including bread enriched with edible insect protein (Acheta domesticus), consumed five times per week over a 2-month intervention period.

OTHER

Mediterranean Diet with Seaweed-Based Burger (chronic phase)

Mediterranean diet including a burger made from edible seaweed, consumed five times per week over a 2-month intervention period.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    collaborator OTHER
  • University of Turin, Italy

    collaborator OTHER
  • Azienda Usl di Bologna

    collaborator OTHER_GOV
  • University of Bologna

    lead OTHER

Principal Investigators

  • Maria Letizia Petroni, Professor · University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2026-10-31
Completion
2027-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553936 on ClinicalTrials.gov