Plant-Based Meat Analogues and Human Health

NCT ID: NCT07031752

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-06
• Study Completion Date: 2024-06-28

Brief 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. 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.

Conditions

Satiation, Satiety; Insulin; Glucose; Leptin Levels; Ghrelin; GLP-1 Concentration; Caloric Intake

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

First Stage

In the first stage, participants were randomly allocated to eat whether vegan meat (VM) or genuine meat (GM) along with water (100 cL).

Group Type: EXPERIMENTAL

Postprandial Vegan Meat

Intervention Type: OTHER

Postprandial responses to one single intake of vegan meat (VM) under fasting conditions.

Postprandial Meat

Intervention Type: OTHER

Postprandial responses to one single intake of genuine meat (GM) under fasting conditions,

Second Stage

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.

Group Type: EXPERIMENTAL

Postprandial Vegan Meat

Intervention Type: OTHER

Postprandial responses to one single intake of vegan meat (VM) under fasting conditions.

Postprandial Meat

Intervention Type: OTHER

Postprandial responses to one single intake of genuine meat (GM) under fasting conditions,

Interventions

Postprandial Vegan Meat

Postprandial responses to one single intake of vegan meat (VM) under fasting conditions.

Intervention Type: OTHER

Postprandial Meat

Postprandial responses to one single intake of genuine meat (GM) under fasting conditions,

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Smoking.
• Drinking alcohol.
• Food allergies.
• Dietary restrictions.
• Not complying with any of the aforementioned requirements

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Science and Innovation, Spain

OTHER_GOV

Sponsor Role: collaborator

Universidad de Extremadura

OTHER

Sponsor Role: lead

Responsible Party

MARIO ESTEVEZ

Full Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Extremadura

Cáceres, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

MCIN/AEI/10.13039/501100011033

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

117/2021

Identifier Type: -

Identifier Source: org_study_id