Clinical trial NCT05375175: Study of the Satiating Properties of a Hybrid Protein Snack Mainly From Chickpeas
Official title: Estudio de Las Propiedades Saciantes de un Snack de proteína híbrida Proveniente Mayoritariamente de Garbanzos
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Nutrition
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 23 participants between 18 and 30 years old, with a ratio between men and women of approximately 50%.

Exclusion Criteria:

* Diabetics
* Chronic medication except contraceptives
* Diagnosis of inflammatory bowel disease (IBD)
* Any serious active disease that prevents or disables to adequately follow the study
* Regular cannabis users
* Alcoholism or active drug dependence
* Inability to give informed consent
* Pregnancy and lactation
* Intolerance to any of the components of the two snack which are intended to be tested

Primary outcomes:
measure: Satiety
timeFrame: post-prandial state: we will study blood samples before eating snacks and the change at 15, 30, 60, 90 and 120 minutes after it.
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IMIM
Study officials:
affiliation: Parc de Salut Mar
name: Montse Fitó
role: PRINCIPAL_INVESTIGATOR
References: