Healthy NutritionLegumSnacksNCT05375175
Study of the Satiating Properties of a Hybrid Protein Snack Mainly From Chickpeas
A study testing Hybrid Snack and Meat snack in people with Healthy Nutrition, run by Parc de Salut Mar at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition
- What is being tested?
- Hybrid Snack and Meat snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jun 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 23 participants between 18 and 30 years old, with a ratio between men and women of approximately 50%.
Who cannot join
- 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
Show all 9Show fewer
- Inability to give informed consent
- Pregnancy and lactation
- Intolerance to any of the components of the two snack which are intended to be tested
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Healthy Nutrition
- Being tested
- Hybrid Snack, Meat snack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid SnackOther
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 snackOther
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%
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Snack | Experimental | Hybrid Snack: combination of legumes, in the highest proportion, and lean meat. Receives: Other: Hybrid Snack |
| Meat snack | Active comparator | Meat snack: composed of meat from loin tape Receives: Other: Meat snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety
Satiety will be measured through the objective determination of endocannabinoid compounds by mass spectrometer analysis
Measured: post-prandial state: we will study blood samples before eating snacks and the change at 15, 30, 60, 90 and 120 minutes after it.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start20 Jun 2022
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Montse Fitó, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375175
- Sponsor's protocol ID
- IDI-20190984
- Acronym
- LegumSnacks
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio de Las Propiedades Saciantes de un Snack de proteína híbrida Proveniente Mayoritariamente de Garbanzos
- ClinicalTrials.gov ID
- NCT05375175
- Acronym / sponsor ID
- LegumSnacks / IDI-20190984
- Conditions
- Healthy Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hybrid Snack | Experimental | Other: Hybrid SnackHybrid Snack: combination of legumes, in the highest proportion, and lean meat. |
| Meat snack | Active comparator | Other: Meat snackMeat snack: composed of meat from loin tape |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 23 participants between 18 and 30 years old, with a ratio between men and women of approximately 50%.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid SnackThe 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% | Other | Hybrid Snack |
| Meat snackThe 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% | Other | Meat snack |
Primary outcome
Satiety
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montse Fitó principal investigator
Parc de Salut Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Snack and Meat snack in people with Healthy Nutrition, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satiety (time frame: post-prandial state: we will study blood samples before eating snacks and the change at 15, 30, 60, 90 and 120 minutes after it.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.