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

Official title

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

Overview

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.

Detailed description

The acute phase of the study is designed to evaluate the short-term effects of foods enriched with alternative protein sources on appetite regulation, satiety, and eating behavior.

Healthy volunteers and individuals with overweight will participate in a controlled, within-subject crossover study conducted at the Department of Agricultural and Food Sciences (DISTAL), University of Bologna. Participants will attend five test sessions over five consecutive weeks.

During each session, participants will consume one of five test products: bread enriched with alternative protein sources (edible insect protein \[Acheta domesticus\], microalgae \[spirulina\], hemp, or legumes) or a wheat-based control bread. All products will be standardized and comparable in terms of energy content.

The order of product administration will be randomized according to a Latin square crossover design, ensuring balanced exposure to all test conditions. Randomization will be stratified by gender and weight status (normal weight/overweight).

At each test session, participants will undergo assessments of postprandial satiety, hunger, food preferences, craving responses, and short-term energy intake using validated scales and dietary assessment tools. This design allows within-subject comparisons across different protein sources while minimizing potential confounding factors.

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.

Primary outcome measures

• Postprandial Satiety Assessed by Visual Analogue Scales (VAS) [Time frame: At each test session following product consumption (5-week period)]
• Food Preference and Craving Responses Assessed by HTAS, LFP, and Hedonic Scale [Time frame: At each test session following product consumption (5-week period)]
• Fasting Blood Glucose [Time frame: At baseline, 2 months, and 4 months]
• Fasting Serum Insulin [Time frame: At baseline, 2 months, and 4 months]
• Serum Triglyceride Levels [Time frame: At baseline, 2 months, and 4 months]
• Total Cholesterol Levels [Time frame: At baseline, 2 months, and 4 months]
• LDL Cholesterol Levels [Time frame: At baseline, 2 months, and 4 months]
• Gastrointestinal Symptoms Assessed by Nepean Dyspepsia Index (NDI) [Time frame: At baseline, 2 months, and 4 months]

Secondary outcome measures (12)

• Postprandial Energy Intake and Energy Compensation Assessed by 24-Hour Dietary Recall [Time frame: Within 24 hours after each test session (5-week period)]
• Incidence of Adverse Events [Time frame: Within 72 hours after each test session (5-week period)]
• Liver Fat Content and Hepatic Stiffness Assessed by FibroScan and Controlled Attenuation Parameter (CAP) [Time frame: At baseline, 2 months, and 4 months]
• Gut Microbiota Composition [Time frame: At baseline and 4 months]
• Appetite Sensations Assessed by Visual Analogue Scales (VAS) [Time frame: At baseline, 2 months, and 4 months]
• Alanine Aminotransferase (ALT) Levels [Time frame: At baseline, 2 months, and 4 months]
• Aspartate Aminotransferase (AST) Levels [Time frame: At baseline, 2 months, and 4 months]
• Gamma-glutamyl Transferase (GGT) Levels [Time frame: At baseline, 2 months, and 4 months]
• Fatty Liver Index (FLI) [Time frame: At baseline, 2 months, and 4 months]
• Complete Blood Count (CBC) [Time frame: At baseline, 2 months, and 4 months]
• Serum Creatinine and Urea [Time frame: At baseline, 2 months, and 4 months]
• Urinary Renal Markers [Time frame: At baseline, 2 months, and 4 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Basic science

Study locations

Italy · 1 center

• University of Bologna, Department of Medical and Surgical Sciences — Bologna

Identifiers

NCT: NCT07553936 · 399/2025/Sper/AOUBo

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗