Plant-Based Meat Analogues and Human Health

NCT07031752 | Completed

• 2 other identifiers: 117/2021MCIN/AEI/10.13039/501100011033
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

seitan; beef; satiation; leptin; ghrelin; GLP-1; insulin

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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.

  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.

  At fixed times after the start of interventions (i.e., 15, 30, 60 and 120 minutes)

Study Arms (2)

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).

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.

Other: Postprandial Vegan Meat; Other: Postprandial Meat

Interventions

Postprandial Vegan Meat OTHER

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

First Stage; Second Stage

Postprandial Meat OTHER

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

First Stage; Second Stage

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Extremadura: lead
• Ministry of Science and Innovation, Spain: collaborator

Study Sites (1)

University of Extremadura

Cáceres, 10003, Spain

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Proffesor

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 22, 2025
• Study Start: February 6, 2022
• Primary Completion: May 8, 2023
• Study Completion: June 28, 2024
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)