Food PreferencesCIPROMEDNCT07553936
Sustainable and Inclusive Use of Alternative Proteins in Mediterranean Supply Chains (CIPROMED)
A study testing Mediterranean Diet with Insect Protein Bread (chronic phase) and Mediterranean Diet with Seaweed-Based Burger (chronic phase) in people with Food Preferences and Satiety and Food Intake, run by University of Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Preferences, Satiety and Food Intake, Appetite Regulation
- What is being tested?
- Mediterranean Diet with Insect Protein Bread (chronic phase) and Mediterranean Diet with Seaweed-Based Burger (chronic phase)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 18 Mar 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Bologna, Department of Medical and Surgical Sciences
Bologna, BO, 40138
Maria Letizia Petroni, Professor, 051/2143688 ext. +39, marialetizia.petroni@unibo.it
Maria Letizia Petroni, Professor
About this study
Official title: Circular and Inclusive Use of Alternative Proteins in Mediterranean Supply Chains (CIPROMED)
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.
Read more
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.
Read the 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.
- Conditions
- Food Preferences, Satiety and Food Intake, Appetite Regulation, Overweight (BMI > 25), Gut Microbiota
- Being tested
- Mediterranean Diet with Control Products (chronic phase), Mediterranean Diet with Insect Protein Bread (chronic phase), Mediterranean Diet with Seaweed-Based Burger (chronic phase)
- Keywords
- Alternative Proteins, Edible Insects, Hemp Protein, Legume Protein, Appetite Regulation, Overweight, Novel Foods, Microalgae (Protein), Food Acceptability, Satiety, Metabolic Health, Gut Microbiota
- Medical subject headings
- Food Preferences, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Mediterranean Diet with Control Products (chronic phase); Other: Mediterranean Diet with Seaweed-Based Burger (chronic phase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: At baseline, 2 months, and 4 months
Secondary outcomes (21)
Postprandial Energy Intake and Energy Compensation Assessed by 24-Hour Dietary Recall
Postprandial energy intake and energy compensation measured using 24-hour dietary recall following consumption of different protein-enriched bread products.
Measured: Within 24 hours after each test session (5-week period)
Incidence of Adverse Events
Participants will complete a 72-hour recall questionnaire to document any adverse reactions they may have experienced following product consumption.
Measured: Within 72 hours after each test session (5-week period)
Liver Fat Content and Hepatic Stiffness Assessed by FibroScan and Controlled Attenuation Parameter (CAP)
Liver fat content and hepatic stiffness measured using transient elastography (FibroScan) and Controlled Attenuation Parameter (CAP) to evaluate changes following dietary interventions with different protein sources.
Measured: At baseline, 2 months, and 4 months
Gut Microbiota Composition
Gut microbiota composition assessed through analysis of fecal samples to evaluate changes following dietary interventions with different protein sources.
Measured: At baseline and 4 months
Appetite Sensations 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.
Measured: At baseline, 2 months, and 4 months
Alanine Aminotransferase (ALT) Levels
Serum alanine aminotransferase (ALT) concentration measured following dietary interventions with different protein sources.
Unit of Measure: U/L
Measured: At baseline, 2 months, and 4 months
Aspartate Aminotransferase (AST) Levels
Serum aspartate aminotransferase (AST) concentration measured following dietary interventions with different protein sources.
Unit of Measure: U/L
Measured: At baseline, 2 months, and 4 months
Gamma-glutamyl Transferase (GGT) Levels
Serum gamma-glutamyl transferase (GGT) concentration measured following dietary interventions with different protein sources.
Unit of Measure: U/L
Measured: At baseline, 2 months, and 4 months
Fatty Liver Index (FLI)
Fatty Liver Index (FLI) score calculated following dietary interventions with different protein sources.
Unit of Measure: Score (o "Unitless")
Measured: At baseline, 2 months, and 4 months
Complete Blood Count (CBC)
Hematological parameters (including red blood cells, white blood cells, and platelets) assessed following dietary interventions with different protein sources.
Unit of Measure: cells/µL
Measured: At baseline, 2 months, and 4 months
Serum Creatinine and Urea
Serum creatinine and urea levels assessed following dietary interventions with different protein sources.
Unit of Measure: mg/dL
Measured: At baseline, 2 months, and 4 months
Urinary Renal Markers
Microalbuminuria and urinary nitrogen levels assessed following dietary interventions with different protein sources.
Unit of Measure: mg/24h
Measured: At baseline, 2 months, and 4 months
C-Reactive Protein (CRP)
Serum C-reactive protein (CRP) levels assessed following dietary interventions with different protein sources.
Unit of Measure: mg/L
Measured: At baseline, 2 months, and 4 months
Blood Pressure
Systolic and diastolic blood pressure assessed following dietary interventions with different protein sources.
Unit of Measure: mmHg
Measured: At baseline, 2 months, and 4 months
Serum Immunoglobulin Levels
Serum immunoglobulin levels (including total IgE) assessed following dietary interventions with different protein sources.
Unit of Measure: IU/mL
Measured: At baseline, 2 months, and 4 months
Body Weight
Body weight measured following dietary interventions with different protein sources.
Unit of Measure: kg
Measured: At baseline, 2 months, and 4 months
Body Circumferences
Body circumferences (including waist, hip, and abdominal) measured following dietary interventions with different protein sources. Unit of Measure: cm
Measured: At baseline, 2 months, and 4 months
Mood Assessed by the Beck Depression Inventory-II (BDI-II)
Assesses the severity of depressive symptoms following dietary interventions with different protein sources. The BDI-II is a 21-item questionnaire. Total scores range from 0 to 63, where higher scores indicate greater severity of depressive symptoms (worse outcome).
Unit of Measure: Score on a scale (0-63)
Measured: At baseline, 2 months, and 4 months
Food Neophobia Assessed by the Food Neophobia Scale (FNS)
Assesses the reluctance to taste new foods following dietary interventions with different protein sources. The FNS consists of 10 items measured on a 7-point Likert scale, with total scores ranging from 8 to 40. Higher scores indicate an increasing neophobic attitude (worse outcome/reluctance to try new foods).
Unit of Measure: Score on a scale (8-40)
Measured: At baseline, 2 months, and 4 months
Food-Related Attentional Bias Assessed by the Pictorial Dot-Probe Task
Evaluates selective attention towards food stimuli (healthy vs. unhealthy) following dietary interventions with different protein sources. Attentional bias is measured as the reaction time difference (in milliseconds) to probes appearing in the location of emotionally salient food stimuli. Faster reaction times to probes appearing in the location of the food stimulus suggest greater attentional bias.
Unit of Measure: milliseconds (ms)
Measured: At baseline and 4 months
Changes in Concomitant Medication Use
Participants will be asked to provide a detailed account of any medications they are currently taking.
Measured: At baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start18 Mar 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food PreferencesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Turin, Italy, Azienda Usl di Bologna
- Responsible party
- Principal investigator, Maria Letizia Petroni, University of Bologna
- Investigators
- Maria Letizia Petroni, Professor, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553936
- Sponsor's protocol ID
- 399/2025/Sper/AOUBo
- Acronym
- CIPROMED
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request to the corresponding investigator, following publication. Data sharing will be subject to institutional policies and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circular and Inclusive Use of Alternative Proteins in Mediterranean Supply Chains (CIPROMED)
- ClinicalTrials.gov ID
- NCT07553936
- Acronym / sponsor ID
- CIPROMED / 399/2025/Sper/AOUBo
- Conditions
- Food Preferences, Satiety and Food Intake, Appetite Regulation, Overweight (BMI > 25), Gut Microbiota
- Keywords
- Alternative Proteins, Edible Insects, Hemp Protein, Legume Protein, Appetite Regulation, Overweight, Novel Foods, Microalgae (Protein)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Turin, Italy, Azienda Usl di Bologna
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control (A) to Insect Bread (B) Sequence | Experimental | Other: Mediterranean Diet with Control Products (chronic phase), Other: Mediterranean Diet with Insect Protein Bread (chronic phase)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. |
| Insect Bread (B) to Control (A) Sequence | Experimental | Other: Mediterranean Diet with Control Products (chronic phase), Other: Mediterranean Diet with Insect Protein Bread (chronic phase)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. |
| Control (A) to Seaweed Burger (C) Sequence | Experimental | Other: Mediterranean Diet with Control Products (chronic phase), Other: Mediterranean Diet with Seaweed-Based Burger (chronic phase)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. |
| Seaweed Burger (C) to Control (A) Sequence | Experimental | Other: Mediterranean Diet with Control Products (chronic phase), Other: Mediterranean Diet with Seaweed-Based Burger (chronic phase)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 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)Mediterranean diet including bread enriched with edible insect protein (Acheta domesticus), consumed five times per week over a 2-month intervention period. | Other | Control (A) to Insect Bread (B) Sequence, Insect Bread (B) to Control (A) Sequence |
| 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. | Other | Control (A) to Seaweed Burger (C) Sequence, Seaweed Burger (C) to Control (A) Sequence |
Primary outcome
Postprandial Satiety Assessed by Visual Analogue Scales (VAS)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
21 secondary outcomes
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
C-Reactive Protein (CRP)
Time frame: At baseline, 2 months, and 4 months
Blood Pressure
Time frame: At baseline, 2 months, and 4 months
Serum Immunoglobulin Levels
Time frame: At baseline, 2 months, and 4 months
Body Weight
Time frame: At baseline, 2 months, and 4 months
Body Circumferences
Time frame: At baseline, 2 months, and 4 months
Mood Assessed by the Beck Depression Inventory-II (BDI-II)
Time frame: At baseline, 2 months, and 4 months
Food Neophobia Assessed by the Food Neophobia Scale (FNS)
Time frame: At baseline, 2 months, and 4 months
Food-Related Attentional Bias Assessed by the Pictorial Dot-Probe Task
Time frame: At baseline and 4 months
Changes in Concomitant Medication Use
Time frame: At baseline and 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request to the corresponding investigator, following publication. Data sharing will be subject to institutional policies and applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Letizia Petroni, Professor principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet with Insect Protein Bread (chronic phase) and Mediterranean Diet with Seaweed-Based Burger (chronic phase) in people with Food Preferences and Satiety and Food Intake, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Letizia Petroni, Professor (051/2143688 ext. +39, marialetizia.petroni@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Satiety Assessed by Visual Analogue Scales (VAS) (time frame: At each test session following product consumption (5-week period)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.