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

NCT05375175 | Unknown

• 1 other identifier: IDI-20190984
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Nutrition

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Hybrid Snack

EXPERIMENTAL

Hybrid Snack: combination of legumes, in the highest proportion, and lean meat.

Other: Hybrid Snack

Meat snack

ACTIVE COMPARATOR

Meat snack: composed of meat from loin tape

Other: Meat snack

Interventions

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%

Hybrid Snack

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%

Meat snack

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: 23 participants between 18 and 30 years old, with a ratio between men and women of approximately 50% will be recruited
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

IMIM

Barcelona, 08003, Spain

Location

Study Officials

• Montse Fitó

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 16, 2022
• Study Start: June 20, 2022
• Primary Completion: October 1, 2022
• Study Completion: June 1, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-04

Locations

ES (1)