Satiation, SatietyVegAnimalNCT07031752
Plant-Based Meat Analogues and Human Health
A study testing Postprandial Vegan Meat and Postprandial Meat in people with Satiation, Satiety and Insulin, run by Universidad de Extremadura at 1 site in Spain.
Trial summary
The goal of this intervention trial is to compare the satiation effects induced by a single intake of vegan meat (VM) and genuine meat (GM) in twenty-five healthy participants, aged 25 to 50 years, from both genders. Participants were randomly allocated to consume either VM or GM along with water during a first sage. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Satiation, Satiety, Insulin, Glucose
- What is being tested?
- Postprandial Vegan Meat and Postprandial Meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 6 Feb 2022to 28 Jun 2024
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18-25 kg/m2.
- No clinical signs of metabolic disease (HbA1c < 5.7%).
- Normotensive (<95th centile for height, sex and age).
- Lipid profiles and liver enzymes (aspartate transaminase (AST) and alanine transaminase (ALT)) within physiological range.
- No active medical treatments and no adverse reaction to gluten.
Who cannot join
- Smoking.
- Drinking alcohol.
- Food allergies.
- Dietary restrictions.
- Not complying with any of the aforementioned requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Plant-Based Meat Analogues Consumption on Human Health
The goal of this intervention trial is to compare the satiation effects induced by a single intake of vegan meat (VM) and genuine meat (GM) in twenty-five healthy participants, aged 25 to 50 years, from both genders. Participants were randomly allocated to consume either VM or GM along with water during a first sage. In a second stage, conducted following the same procedures as the first after a washout period, participants shifted received the alternative meal (they shifted positions regarding first stage). Blood samples were collected under fasting conditions and at 15, 30, 60 and 120 minutes after meal intake to assess the concentration of glucose, cytokines, leptin, ghrelin, glucagon-like peptide-1 (GLP-1), cholecystokinin (CCK) and insulin. Additionally, urine and feces were collected under fasting conditions at the end of each session.
Read the detailed description
The study was designed as a postprandial, randomized and crossover intervention trial aimed at comparing the satiation induced by a single intake of grilled vegan "meat" and grilled beef loin at isocaloric and isoprotein conditions. Twenty-five healthy participants (25-50 years old) from both genders (15 females and 10 males) were recruited for the trial and randomly included in a two-stage crossover study. Previously, participants expressed their willingness to participate by signing an informed consent.
In the first stage, participants (fasted during the last 12 hours, without having had a late or heavy dinner, and without engaging in intense physical activity the previous afternoon or evening) were randomly allocated to eat whether vegan meat (VM) or genuine meat (GM) along with water (100 cL). Under fasting conditions, blood samples were collected via venous cannula by clinical nurse collaborators, and the fluids were subsequently treated with a protease inhibitor cocktail by experienced laboratory technicians. Consumption of whether VM or GM was carried out in individual sensory booths at room temperature (22ºC). At fixed postprandial times (i.e., 15, 30, 60 and 120 minutes) blood was collected in dipotassium ethylenediaminetetraacetic acid (K2EDTA) Vacutainer® tubes and treated for the analysis of glucose, cytokines, leptin, ghrelin, GLP-1, CCK and insulin concentrations. During the postprandial period, participants were instructed to remain seated and engage in mild intellectual activity, such as reading a book or working on the computer. Any activity that would interfere with the digestion process or influence the postprandial response to the foods under study was discouraged. Participants were specifically asked not to move around, play games or watch movies. After 120 minutes postprandial time, and in order to assess compensatory caloric intake after the first meal, participants were offered to eat spaghetti Bolognese ad libitum with 100 cL of water until they were fully and comfortably satiated. Caloric intake was recorded by calculating the amount of food had during this ad libitum meal.
The second stage, conducted after a minimum washout period of two weeks following the first stage, was conducted following the same procedure as described for the first stage. Yet, participants shifted positions in relation to the first meal. Researchers and technicians involved in the analysis of samples were blinded to the origin of the samples and the identity of the participants. This information was guarded by an individual unconnected to the study until the completion of the statistical analysis.
- Conditions
- Satiation, Satiety, Insulin, Glucose, Leptin Levels, Ghrelin, GLP-1 Concentration
- Being tested
- Postprandial Vegan Meat, Postprandial Meat
- Keywords
- seitan, beef, satiation, leptin, ghrelin, GLP-1, insulin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postprandial Vegan MeatOther
Postprandial responses to one single intake of vegan meat (VM) under fasting conditions.
Postprandial MeatOther
Postprandial responses to one single intake of genuine meat (GM) under fasting conditions,
| Study group | Role | What they receive |
|---|---|---|
| First Stage | Experimental | In the first stage, participants were randomly allocated to eat whether vegan meat (VM) or genuine meat (GM) along with water (100 cL). Receives: Other: Postprandial Vegan Meat; Other: Postprandial Meat |
| Second Stage | Experimental | The second stage, conducted after a minimum washout period of two weeks following the first stage, was conducted following the same procedure as described for the first stage. Yet, participants shifted positions in relation to the first meal. Receives: Other: Postprandial Vegan Meat; Other: Postprandial Meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose levels at predefined postprandial times
Biochemical profiling of blood samples were carried out in order to analyse glucose concentration at fixed postprandial times
Measured: At fixed postprandial times after the start of interventions (i.e., 15, 30, 60 and 120 minutes)
Plasma insulin levels at predefined postprandial times
Biochemical profiling of blood samples were carried out in order to analyse insulin concentrations at fixed postprandial times
Measured: At fixed postprandial times after the start of interventions (i.e., 15, 30, 60 and 120 minutes)
Circulating leptin levels in plasma at fixed postprandial times
Plasma leptin concentration were measured at predefined times after de start of interventions using an enzyme-linked immunosorbent assay (ELISA)-based multiplex assay.
Measured: At fixed times after the start of interventions (i.e., 15, 30, 60 and 120 minutes)
Circulating ghrelin levels in plasma at fixed postprandial times
Plasma ghrelin concentration were measured at predefined times after de start of interventions using an enzyme-linked immunosorbent assay (ELISA)-based multiplex assay.
Measured: At fixed times after the start of interventions (i.e., 15, 30, 60 and 120 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start6 Feb 2022
- Primary completion8 May 2023
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satiation, SatietyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Responsible party
- Principal investigator, MARIO ESTEVEZ, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031752
- Sponsor's protocol ID
- 117/2021
- Other IDs
- MCIN/AEI/10.13039/501100011033
- Acronym
- VegAnimal
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Plant-Based Meat Analogues Consumption on Human Health
- ClinicalTrials.gov ID
- NCT07031752
- Acronym / sponsor ID
- VegAnimal / 117/2021
- Conditions
- Satiation, Satiety, Insulin, Glucose, Leptin Levels, Ghrelin, GLP-1 Concentration
- Keywords
- seitan, beef, satiation, leptin, ghrelin, GLP-1, insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Study start
- 6 Feb 2022 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 22 Jun 2025 (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.
The goal of this intervention trial is to compare the satiation effects induced by a single intake of vegan meat (VM) and genuine meat (GM) in twenty-five healthy participants, aged 25 to 50 years, from both genders. Participants were randomly allocated to consume either VM or GM along with water during a first sage. In a second stage, conducted following the same procedures as the first after a washout period, participants shifted received the alternative meal (they shifted positions regarding first stage). Blood samples were collected under fasting conditions and at 15, 30, 60 and 120 minutes after meal intake to assess the concentration of glucose, cytokines, leptin, ghrelin, glucagon-like peptide-1 (GLP-1), cholecystokinin (CCK) and insulin. Additionally, urine and feces were collected under fasting conditions at the end of each session.
Detailed description
The study was designed as a postprandial, randomized and crossover intervention trial aimed at comparing the satiation induced by a single intake of grilled vegan "meat" and grilled beef loin at isocaloric and isoprotein conditions. Twenty-five healthy participants (25-50 years old) from both genders (15 females and 10 males) were recruited for the trial and randomly included in a two-stage crossover study. Previously, participants expressed their willingness to participate by signing an informed consent.
In the first stage, participants (fasted during the last 12 hours, without having had a late or heavy dinner, and without engaging in intense physical activity the previous afternoon or evening) were randomly allocated to eat whether vegan meat (VM) or genuine meat (GM) along with water (100 cL). Under fasting conditions, blood samples were collected via venous cannula by clinical nurse collaborators, and the fluids were subsequently treated with a protease inhibitor cocktail by experienced laboratory technicians. Consumption of whether VM or GM was carried out in individual sensory booths at room temperature (22ºC). At fixed postprandial times (i.e., 15, 30, 60 and 120 minutes) blood was collected in dipotassium ethylenediaminetetraacetic acid (K2EDTA) Vacutainer® tubes and treated for the analysis of glucose, cytokines, leptin, ghrelin, GLP-1, CCK and insulin concentrations. During the postprandial period, participants were instructed to remain seated and engage in mild intellectual activity, such as reading a book or working on the computer. Any activity that would interfere with the digestion process or influence the postprandial response to the foods under study was discouraged. Participants were specifically asked not to move around, play games or watch movies. After 120 minutes postprandial time, and in order to assess compensatory caloric intake after the first meal, participants were offered to eat spaghetti Bolognese ad libitum with 100 cL of water until they were fully and comfortably satiated. Caloric intake was recorded by calculating the amount of food had during this ad libitum meal.
The second stage, conducted after a minimum washout period of two weeks following the first stage, was conducted following the same procedure as described for the first stage. Yet, participants shifted positions in relation to the first meal. Researchers and technicians involved in the analysis of samples were blinded to the origin of the samples and the identity of the participants. This information was guarded by an individual unconnected to the study until the completion of the statistical analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Stage | Experimental | Other: Postprandial Vegan Meat, Other: Postprandial MeatIn the first stage, participants were randomly allocated to eat whether vegan meat (VM) or genuine meat (GM) along with water (100 cL). |
| Second Stage | Experimental | Other: Postprandial Vegan Meat, Other: Postprandial MeatThe second stage, conducted after a minimum washout period of two weeks following the first stage, was conducted following the same procedure as described for the first stage. Yet, participants shifted positions in relation to the first meal. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) between 18-25 kg/m2.
- No clinical signs of metabolic disease (HbA1c < 5.7%).
- Normotensive (<95th centile for height, sex and age).
- Lipid profiles and liver enzymes (aspartate transaminase (AST) and alanine transaminase (ALT)) within physiological range.
- No active medical treatments and no adverse reaction to gluten.
Key exclusion criteria (5 listed)
- Smoking.
- Drinking alcohol.
- Food allergies.
- Dietary restrictions.
- Not complying with any of the aforementioned requirements
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 |
|---|---|---|
| Postprandial Vegan MeatPostprandial responses to one single intake of vegan meat (VM) under fasting conditions. | Other | First Stage, Second Stage |
| Postprandial MeatPostprandial responses to one single intake of genuine meat (GM) under fasting conditions, | Other | First Stage, Second Stage |
Primary outcome
Plasma glucose levels at predefined postprandial times
Time frame: At fixed postprandial times after the start of interventions (i.e., 15, 30, 60 and 120 minutes)
Biochemical profiling of blood samples were carried out in order to analyse glucose concentration at fixed postprandial times
Plasma insulin levels at predefined postprandial times
Time frame: At fixed postprandial times after the start of interventions (i.e., 15, 30, 60 and 120 minutes)
Biochemical profiling of blood samples were carried out in order to analyse insulin concentrations at fixed postprandial times
Circulating leptin levels in plasma at fixed postprandial times
Time frame: At fixed times after the start of interventions (i.e., 15, 30, 60 and 120 minutes)
Plasma leptin concentration were measured at predefined times after de start of interventions using an enzyme-linked immunosorbent assay (ELISA)-based multiplex assay.
Circulating ghrelin levels in plasma at fixed postprandial times
Time frame: At fixed times after the start of interventions (i.e., 15, 30, 60 and 120 minutes)
Plasma ghrelin concentration were measured at predefined times after de start of interventions using an enzyme-linked immunosorbent assay (ELISA)-based multiplex assay.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postprandial Vegan Meat and Postprandial Meat in people with Satiation, Satiety and Insulin, run by Universidad de Extremadura 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 22 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma glucose levels at predefined postprandial times (time frame: At fixed postprandial times after the start of interventions (i.e., 15, 30, 60 and 120 minutes)). The study lists 4 primary outcomes in all. 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 22 Jun 2025.