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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Postprandial Satiety Assessed by Visual Analogue Scales (VAS) — At each test session following product consumption (5-week period)
  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.
• Food Preference and Craving Responses Assessed by HTAS, LFP, and Hedonic Scale — At each test session following product consumption (5-week period)
  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).
• Fasting Blood Glucose — At baseline, 2 months, and 4 months
  Fasting plasma glucose concentration, assessed following the dietary intervention with alternative protein sources. Unit of Measure: mg/dL
• Fasting Serum Insulin — At baseline, 2 months, and 4 months
  Fasting serum insulin concentration measured following dietary interventions with alternative protein sources. Unit of Measure: µIU/mL.
• Serum Triglyceride Levels — At baseline, 2 months, and 4 months
  Fasting serum triglyceride concentration measured following dietary interventions with alternative protein sources. Unit of Measure: mg/dL
• Total Cholesterol Levels — At baseline, 2 months, and 4 months
  Fasting serum high-density lipoprotein (HDL) cholesterol concentration measured following dietary interventions with alternative protein sources. Unit of Measure: mg/dL
• LDL Cholesterol Levels — At baseline, 2 months, and 4 months
  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
• Gastrointestinal Symptoms Assessed by Nepean Dyspepsia Index (NDI) — At baseline, 2 months, and 4 months
  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.

Trial sites (1)

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