NCT06618729

Brief Summary

The aim of this study is to investigate the postprandial metabolic responses to plant-based meat alternatives made from different protein ingredients (pea, wheat or soy protein) in comparison to chicken in healthy adults. Therefore, young healthy subjects consume 4 test meals with 40 g of protein from pea protein, wheat protein, soy protein or chicken in a randomized order. In a postprandial period of 6 hours, parameters of protein, glucose and lipid metabolism (i.a. plasma amino acids), gastric emptying and hunger/satiety are analysed. It is assumed that the plasma amino acid profile after plant protein ingestion differs depending on protein source and in comparison to chicken protein.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

September 20, 2024

Last Update Submit

June 13, 2025

Conditions

Plasma Amino Acid Appearance and DisappearancePostprandial Metabolic Events

Keywords

Postprandial metabolic events

Outcome Measures

Primary Outcomes (1)

  • Amino acid profile in blood

    Analysis of amino acid profile in plasma (nmol/ml)

    Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)

Secondary Outcomes (22)

  • Amino acid profile in urine

    Postprandial period of 6 hours

  • Urea in blood

    Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)

  • Nitrogen in blood

    Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)

  • Glucose in blood

    Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)

  • Insulin in blood

    Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)

  • +17 more secondary outcomes

Study Arms (4)

Pea protein

EXPERIMENTAL

Participants randomized to receive a meal containing 40 g of protein from pea protein extrudate

Other: Pea protein

Wheat protein

EXPERIMENTAL

Participants randomized to receive a meal containing 40 g of protein from wheat protein extrudate

Other: Wheat protein

Soy protein

EXPERIMENTAL

Participants randomized to receive a meal containing 40 g of protein from soy protein extrudate

Other: Soy protein

Chicken

ACTIVE COMPARATOR

Participants randomized to receive a meal containing 40 g of protein from chicken meat

Other: Chicken

Interventions

Pea proteinOTHER

Ingestion of a meal containing 40 g of protein from pea protein extrudate

Pea protein
Wheat proteinOTHER

Ingestion of a meal containing 40 g of protein from wheat protein extrudate

Wheat protein
Soy proteinOTHER

Ingestion of a meal containing 40 g of protein from soy protein extrudate

Soy protein
ChickenOTHER

Ingestion of a meal containing 40 g of protein from chicken

Chicken

Eligibility Criteria

Age20 Years - 40 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • non-smoking
  • metabolically healthy
  • normal weight (BMI: 18,5 - 24,9 kg/m2)
  • written informed consent

You may not qualify if:

  • pregnancy, lactation
  • hypo- or hypertension
  • underweight or overweight/obesity
  • food intolerances and allergies (especially soy, pea, wheat/gluten)
  • malabsorption syndromes
  • gastrointestinal diseases
  • thyroid diseases
  • diabetes mellitus type 1 and type 2
  • impaired kidney or liver function
  • anaemia
  • blood coagulation disorders
  • irregular menstrual cycle
  • endometriosis, severe menstrual problems
  • hormonal contraception
  • regular use of medications (especially habitual use of paracetamol or medications that may interact with paracetamol)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bonn, Institute of Nutritional and Food Sciences, Nutritional Physiology

Bonn, North Rhine-Westphalia, 53115, Germany

Location

MeSH Terms

Interventions

Pea ProteinsSoybean Proteins

Intervention Hierarchy (Ancestors)

Plant Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesSoy FoodsVegetable ProductsVegetables

Study Officials

  • Sarah Egert, Prof PhD

    University of Bonn, Institute of Nutritional and Food Sciences, Nutritional Physiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Sarah Egert

Study Record Dates

First Submitted

September 20, 2024

First Posted

October 1, 2024

Study Start

October 31, 2024

Primary Completion

May 28, 2025

Study Completion

May 28, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Locations

DE(1)