NCT Number: NCT07553936
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Bologna, BO, 40138, Italy
Location status: Recruiting
Maria Letizia Petroni, Professor
CONTACT
051/2143688 ext. +39
Maria Letizia Petroni, Professor
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 including bread enriched with edible insect protein (Acheta domesticus), consumed five times per week over a 2-month intervention period.
Mediterranean diet including a burger made from edible seaweed, consumed five times per week over a 2-month intervention period.
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.
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).
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
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.
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
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
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
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.
Time frame: Within 24 hours after each test session (5-week period)
Postprandial energy intake and energy compensation measured using 24-hour dietary recall following consumption of different protein-enriched bread products.
Time frame: Within 72 hours after each test session (5-week period)
Participants will complete a 72-hour recall questionnaire to document any adverse reactions they may have experienced following product consumption.
Time frame: At baseline, 2 months, and 4 months
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.
Time frame: At baseline and 4 months
Gut microbiota composition assessed through analysis of fecal samples to evaluate changes following dietary interventions with different protein sources.
Time frame: At baseline, 2 months, and 4 months
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.
Time frame: At baseline, 2 months, and 4 months
Serum alanine aminotransferase (ALT) concentration measured following dietary interventions with different protein sources.
Unit of Measure: U/L
Time frame: At baseline, 2 months, and 4 months
Serum aspartate aminotransferase (AST) concentration measured following dietary interventions with different protein sources.
Unit of Measure: U/L
Time frame: At baseline, 2 months, and 4 months
Serum gamma-glutamyl transferase (GGT) concentration measured following dietary interventions with different protein sources.
Unit of Measure: U/L
Time frame: At baseline, 2 months, and 4 months
Fatty Liver Index (FLI) score calculated following dietary interventions with different protein sources.
Unit of Measure: Score (o "Unitless")
Time frame: At baseline, 2 months, and 4 months
Hematological parameters (including red blood cells, white blood cells, and platelets) assessed following dietary interventions with different protein sources.
Unit of Measure: cells/µL
Time frame: At baseline, 2 months, and 4 months
Serum creatinine and urea levels assessed following dietary interventions with different protein sources.
Unit of Measure: mg/dL
Time frame: At baseline, 2 months, and 4 months
Microalbuminuria and urinary nitrogen levels assessed following dietary interventions with different protein sources.
Unit of Measure: mg/24h
Time frame: At baseline, 2 months, and 4 months
Serum C-reactive protein (CRP) levels assessed following dietary interventions with different protein sources.
Unit of Measure: mg/L
Time frame: At baseline, 2 months, and 4 months
Systolic and diastolic blood pressure assessed following dietary interventions with different protein sources.
Unit of Measure: mmHg
Time frame: At baseline, 2 months, and 4 months
Serum immunoglobulin levels (including total IgE) assessed following dietary interventions with different protein sources.
Unit of Measure: IU/mL
Time frame: At baseline, 2 months, and 4 months
Body weight measured following dietary interventions with different protein sources.
Unit of Measure: kg
Time frame: At baseline, 2 months, and 4 months
Body circumferences (including waist, hip, and abdominal) measured following dietary interventions with different protein sources. Unit of Measure: cm
Time frame: At baseline, 2 months, and 4 months
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)
Time frame: At baseline, 2 months, and 4 months
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)
Time frame: At baseline and 4 months
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)
Time frame: At baseline and 4 months
Participants will be asked to provide a detailed account of any medications they are currently taking.
Contact information is provided by the study sponsor or research team.
University of Bologna
Other
Circular and Inclusive Use of Alternative Proteins in Mediterranean Supply Chains (CIPROMED)
Acronym: CIPROMED
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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