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

NCT07553936 | Recruiting

• 1 other identifier: 399/2025/Sper/AOUBo
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Alternative Proteins; Edible Insects; Hemp Protein; Legume Protein; Appetite Regulation; Overweight; Novel Foods; Microalgae (Protein); Food Acceptability; Satiety; Metabolic Health; Gut Microbiota

Outcome Measures

Primary Outcomes (8)

• Postprandial Satiety Assessed by Visual Analogue Scales (VAS)

  Subjective appetite sensations are assessed using a customized 100 mm Visual Analogue Scale (VAS). The scale evaluates four primary domains: hunger, fullness (satiety), desire to eat, and prospective food consumption. Participants mark a point on a 100 mm line anchored by "not at all" (0 mm) and "extremely" (100 mm). Total scores for each domain range from 0 to 100, where higher scores for satiety indicate a greater feeling of fullness, and higher scores for hunger indicate a greater urge to eat. Post-prandial ratings are measured at baseline and at specific intervals following the consumption of protein-enriched bread products.

  At each test session following product consumption (5-week period)

• Food Preference and Craving Responses Assessed by HTAS, LFP, and Hedonic Scale

  Food preference, motivation, and attitudes were assessed following consumption of different protein-enriched bread products using three distinct validated instruments: Health and Taste Attitude Scales (HTAS): The validated Italian version of the HTAS was used to evaluate psychological attitudes toward food. The questionnaire comprises six subscales divided into two dimensions: Health-related attitudes (General health interest, Light product interest, Natural product interest) and Taste-related attitudes (Craving for sweet foods, Pleasure orientation, Using food as a reward). 9-Point Hedonic Scale: Sensory liking of the test foods was evaluated using a 9-point scale ranging from 1 ('Extremely unpleasant') to 9 ('Extremely pleasant'). Leeds Food Preference Questionnaire (LFP): This psychometric tool was used to assess food motivation via food images. It measures two distinct components: 'Liking' (perceived pleasantness) and 'Wanting' (motivation to consume the food at testing).

  At each test session following product consumption (5-week period)

• Fasting Blood Glucose

  Fasting plasma glucose concentration, assessed following the dietary intervention with alternative protein sources. Unit of Measure: mg/dL

  At baseline, 2 months, and 4 months

• Fasting Serum Insulin

  Fasting serum insulin concentration measured following dietary interventions with alternative protein sources. Unit of Measure: µIU/mL.

  At baseline, 2 months, and 4 months

• Serum Triglyceride Levels

  Fasting serum triglyceride concentration measured following dietary interventions with alternative protein sources. Unit of Measure: mg/dL

  At baseline, 2 months, and 4 months

• Total Cholesterol Levels

  Fasting serum high-density lipoprotein (HDL) cholesterol concentration measured following dietary interventions with alternative protein sources. Unit of Measure: mg/dL

  At baseline, 2 months, and 4 months

• LDL Cholesterol Levels

  Fasting serum low-density lipoprotein (LDL) cholesterol concentration, calculated using the Friedewald formula, measured following dietary interventions with alternative protein sources. Unit of Measure: mg/dL

  At baseline, 2 months, and 4 months

• Gastrointestinal Symptoms Assessed by Nepean Dyspepsia Index (NDI)

  Gastrointestinal symptoms were assessed following dietary interventions with different protein sources using the Nepean Dyspepsia Index (NDI). This validated instrument measures symptom severity, quality of life, and the impact of functional dyspepsia on daily living. The study utilizes the version validated through translation from Australian English to Italian.

  At baseline, 2 months, and 4 months

Secondary Outcomes (21)

• Postprandial Energy Intake and Energy Compensation Assessed by 24-Hour Dietary Recall

  Within 24 hours after each test session (5-week period)

• Incidence of Adverse Events

  Within 72 hours after each test session (5-week period)

• Liver Fat Content and Hepatic Stiffness Assessed by FibroScan and Controlled Attenuation Parameter (CAP)

  At baseline, 2 months, and 4 months

• Gut Microbiota Composition

  At baseline and 4 months

• Appetite Sensations Assessed by Visual Analogue Scales (VAS)

  At baseline, 2 months, and 4 months

Study Arms (4)

Control (A) to Insect Bread (B) Sequence

EXPERIMENTAL

Participants follow a Mediterranean diet including control products (legume bread and/or standard fish burger) during the first intervention period, followed by a Mediterranean diet including insect protein-enriched bread (Acheta domesticus) during the second period. Each period lasts approximately 2 months. Participants are assigned to one of four randomized sequences according to a Latin square crossover design.

Other: Mediterranean Diet with Control Products (chronic phase); Other: Mediterranean Diet with Insect Protein Bread (chronic phase)

Insect Bread (B) to Control (A) Sequence

EXPERIMENTAL

Participants follow a Mediterranean diet including insect protein-enriched bread (Acheta domesticus) during the first intervention period, followed by a Mediterranean diet including control products (legume bread and/or standard fish burger) during the second period. Each period lasts approximately 2 months. Participants are assigned to one of four randomized sequences according to a Latin square crossover design.

Other: Mediterranean Diet with Control Products (chronic phase); Other: Mediterranean Diet with Insect Protein Bread (chronic phase)

Control (A) to Seaweed Burger (C) Sequence

EXPERIMENTAL

Participants follow a Mediterranean diet including control products (legume bread and/or standard fish burger) during the first intervention period, followed by a Mediterranean diet including a seaweed-based burger during the second period. Each period lasts approximately 2 months. Participants are assigned to one of four randomized sequences according to a Latin square crossover design.

Other: Mediterranean Diet with Control Products (chronic phase); Other: Mediterranean Diet with Seaweed-Based Burger (chronic phase)

Seaweed Burger (C) to Control (A) Sequence

EXPERIMENTAL

Participants follow a Mediterranean diet including a seaweed-based burger during the first intervention period, followed by a Mediterranean diet including control products (legume bread and/or standard fish burger) during the second period. Each period lasts approximately 2 months. Participants are assigned to one of four randomized sequences according to a Latin square crossover design.

Other: Mediterranean Diet with Control Products (chronic phase); Other: Mediterranean Diet with Seaweed-Based Burger (chronic phase)

Interventions

Mediterranean Diet with Control Products (chronic phase) OTHER

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.

Control (A) to Insect Bread (B) Sequence; Control (A) to Seaweed Burger (C) Sequence; Insect Bread (B) to Control (A) Sequence; Seaweed Burger (C) to Control (A) Sequence

Mediterranean Diet with Insect Protein Bread (chronic phase) OTHER

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

Control (A) to Insect Bread (B) Sequence; Insect Bread (B) to Control (A) Sequence

Mediterranean Diet with Seaweed-Based Burger (chronic phase) OTHER

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

Control (A) to Seaweed Burger (C) Sequence; Seaweed Burger (C) to Control (A) Sequence

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• University of Turin, Italy: collaborator
• Azienda Usl di Bologna: collaborator

Study Sites (1)

University of Bologna, Department of Medical and Surgical Sciences

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Food Preferences; Overweight

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Maria Letizia Petroni, Professor

  University of Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Letizia Petroni, Professor

CONTACT

051/2143688; marialetizia.petroni@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a spontaneous, exploratory, interventional, controlled, open-label, randomized, national multicenter study evaluating novel food prototypes. In the acute phase, healthy volunteers and overweight participants will consume bread enriched with alternative protein sources (edible insects \[Acheta domesticus\], microalgae \[spirulina\], hemp, or legumes) in a controlled setting at the Department of Agricultural and Food Sciences (DISTAL), University of Bologna. In the chronic phase, participants will consume alternative protein-based foods at home, including insect-based bread or seaweed-based burgers. Overweight participants will be enrolled at the Endocrinology Unit of IRCCS Azienda Ospedaliero-Universitaria di Bologna, which will also conduct medical screening and safety monitoring. Healthy volunteers will be enrolled at DISTAL and recruited through institutional advertisements.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 28, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)