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

• Sponsor: Parc de Salut Mar (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05375175
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.4
• Patients Per Site Per Month: 2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Nutrition	Other: Hybrid Snack; Other: Meat snack	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.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.
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: 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
• Primary Purpose: Basic Science
• Official Title: Estudio de Las Propiedades Saciantes de un Snack de proteína híbrida Proveniente Mayoritariamente de Garbanzos
• Actual Study Start Date: Jun 20, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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%

Outcome Measures

Primary Outcome Measures

1. Satiety [post-prandial state: we will study blood samples before eating snacks and the change at 15, 30, 60, 90 and 120 minutes after it.]

   Satiety will be measured through the objective determination of endocannabinoid compounds by mass spectrometer analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IMIM	Barcelona		Spain	08003

Sponsors and Collaborators

• Parc de Salut Mar

Investigators

• Principal Investigator: Montse Fitó, Parc de Salut Mar

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Parc de Salut Mar
• ClinicalTrials.gov Identifier: NCT05375175
• Other Study ID Numbers: IDI-20190984
• First Posted: May 16, 2022
• Last Update Posted: Jun 28, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 28, 2022