Study of the Satiating Properties of a Hybrid Protein Snack Mainly From Chickpeas (LegumSnacks)

Estudio de Las Propiedades Saciantes de un Snack de proteína híbrida Proveniente Mayoritariamente de Garbanzos

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy Nutrition
• Intervention / Treatment: Other: Hybrid Snack; Other: Meat snack

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.

• Study Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • IMIM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hybrid Snack; Hybrid Snack: combination of legumes, in the highest proportion, and lean meat.	Other: Hybrid Snack; 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%
Active Comparator: Meat snack; Meat snack: composed of meat from loin tape	Other: Meat snack; 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Investigators: Principal Investigator: Montse Fitó, Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IDI-20190984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No