Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A randomized, crossover and controlled clinical trial will be developed in 23 individuals to evaluate the postprandial effect of consuming snacks rich in vegetable and animal protein compared to a high-quality pork sausage
A randomized, crossover and controlled clinical trial will be developed in 23 individuals to evaluate the postprandial effect of consuming snacks rich in vegetable and animal protein compared to a high-quality pork sausage. Each of the participants will consume the two types of snacks (20 grams) following a random assignment order. The design is randomised and cross-over.
A greater satiating effect is expected with the hybrid snack, given that the fiber in chickpea flour is higher than that of dry chickpeas. In addition, chickpea flour is rich in soluble fiber (a type of fiber that helps retain water and therefore slows down digestion) having positive effects on the gastrointestinal tract and on the metabolism of LDL cholesterol, as well as on blood glucose .
Foods high in complex carbohydrates and fiber have a satiating effect due to their fiber content. It is known that the most satiating macronutrient is protein if the food also contains fiber, this favors that some nutrients are not fully absorbed, including fat. Hence, these foods have a satiety index greater than fat itself, thus favoring adherence to diet and body weight, since it is possible to control portions, avoiding snacking on unhealthy products.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid Snack | Experimental | Hybrid Snack: combination of legumes, in the highest proportion, and lean meat. |
|
| Meat snack | Active Comparator | Meat snack: composed of meat from loin tape |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Snack | Other | The intervention will consist of the administration of 20 g of the snack (produced by Fertinagro Company) that will be eaten at fasting in the morning. Participants will be fasting for 12 hours for solid or liquid food and more than 1 hour after ingestion of water. Blood samples will be obtained after venepuncture at 7:45 a.m. before eating snacks and 15, 30, 60, 90 and 120 minutes after it. Hybrid snack: combination of legumes in the highest proportion and lean meat. It will have the following composition: Ingredients (%): Chickpea flour 45.40% Natural emulsifier 0.40% Meat 15.50% Olive oil 1.00% Sunflower oil 4.00% Water 22.50% Onion powder 0.30% Garlic powder 0.20% Thyme 0.60% Tomato powder 10.00% |
| Measure | Description | Time Frame |
|---|---|---|
| Satiety | Satiety will be measured through the objective determination of endocannabinoid compounds by mass spectrometer analysis | post-prandial state: we will study blood samples before eating snacks and the change at 15, 30, 60, 90 and 120 minutes after it. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
23 participants between 18 and 30 years old, with a ratio between men and women of approximately 50% will be recruited
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Montse Fitó | Parc de Salut Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMIM | Barcelona | 08003 | Spain |
A consortium agreement will be established with the collaborating partners at the beginning of the project, focusing on confidentiality issues, agreements of all parties and patent possibilities.
The study data must be verifiable with the source data, which necessitates access to all original records, laboratory reports, and subject records. The confidentiality of the data and the identity of the patients will be maintained during the study and after its completion. Only the Principal Investigator and authorized study personnel will have access to these confidential records.
The data and other information related to the project is managed through REDCap, a secure web application that is installed on a server located in CIBER. The IP is the repository owner of the information contained in the project database.
No data used in the analysis and subsequent disclosure of the study results will contain any identifiable reference to patient names.
Not provided
Not provided
Not provided
Not provided
Not provided
A randomized, crossover and controlled clinical trial will be developed with 23 individuals to evaluate the post-prandial effect of consuming snacks rich in vegetable and animal protein compared to a high-quality pork sausage. Each participant will consume the 2 types of snacks (20 grams) following a random assignment order.
It is a randomized, crossover, double-blind, and controlled trial. The intervention will consist of the administration of 20 g of one or another snack (Fertinagro Company) that will be eaten at fasting in the morning. Participants will be fasting for 12 hours for solid or liquid food and more than 1 hour after ingestion of water. Blood samples will be obtained after venepuncture at 7:45 a.m. before eating snacks and 15, 30, 60, 90 and 120 minutes after it.
Within a period of 20 days +_5 days, the intervention will be carried out with the second type of snack according to randomization. The total duration of the study is expected to be 2.5 to 3 months.
Not provided
Not provided
To ensure double-blindness, the wrapper of the snacks will be the same and nursing will only be able to distinguish the product by the assigned code, as will the statistician
|
| Meat snack | Other | The intervention will consist of the administration of 20 g of the snack (produced by Fertinagro Company) that will be eaten at fasting in the morning. Participants will be fasting for 12 hours for solid or liquid food and more than 1 hour after ingestion of water. Blood samples will be obtained after venepuncture at 7:45 a.m. before eating snacks and 15, 30, 60, 90 and 120 minutes after it. Snack sausage: Composed solely of meat from loin tape It will have the following composition: Ingredients (%): Shoulder meat 4 mm 94.13% Low sodium salt 3.30% Maltodextrin 1.65% Spices 0.28% Natural dye 0.64% |
|