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

NCT ID: NCT05375175

Last Updated: 2022-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2023-06-01

Brief Summary

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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

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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.

Conditions

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Healthy Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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

Study Groups

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Hybrid Snack

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

Group Type EXPERIMENTAL

Hybrid Snack

Intervention Type 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%

Meat snack

Meat snack: composed of meat from loin tape

Group Type ACTIVE_COMPARATOR

Meat snack

Intervention Type 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%

Interventions

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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%

Intervention Type 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%

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Montse Fitó

Role: PRINCIPAL_INVESTIGATOR

Parc de Salut Mar

Locations

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IMIM

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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IDI-20190984

Identifier Type: -

Identifier Source: org_study_id

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