NCT06155656

Brief Summary

The aim of this study is to investigate the postprandial metabolic responses to plant-based protein ingredients of different degrees of processing (pea protein concentrate, isolate, and extrudate) and in comparison to whey protein in healthy adults. Therefore, young healthy subjects consume 4 test meals with 25 g of protein from pea protein concentrate, pea protein isolate, pea protein extrudate or whey protein in a randomized order. In a postprandial period of 6 hours, parameters of protein and glucose 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 processing level of the protein ingredients and in comparison to whey 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 Jan 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

November 7, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 22, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

November 7, 2023

Last Update Submit

April 17, 2025

Conditions

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 5 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 300 minutes)

Secondary Outcomes (12)

  • Parameters of protein metabolism in blood I

    Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)

  • Parameters of protein metabolism in blood II

    Postprandial period of 5 hours (Time points: fasting (0) and 60, 120, 180, 240 and 300 minutes)

  • Parameters of glucose metabolism in blood I

    Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)

  • Parameters of glucose metabolism in blood II

    Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)

  • Gastric emptying rate

    Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)

  • +7 more secondary outcomes

Study Arms (4)

Pea concentrate

EXPERIMENTAL

Participants randomized to receive a soup containing 25 g of protein from pea protein concentrate

Other: Pea protein concentrate

Pea isolate

EXPERIMENTAL

Participants randomized to receive a soup containing 25 g of protein from pea protein isolate

Other: Pea protein isolate

Pea extrudate

EXPERIMENTAL

Participants randomized to receive a soup containing 25 g of protein from pea protein extrudate

Other: Pea protein extrudate

Whey

ACTIVE COMPARATOR

Participants randomized to receive a soup containing 25 g of protein from whey protein

Other: Whey protein

Interventions

Ingestion of a soup containing 25 g of protein from pea protein concentrate

Pea concentrate

Ingestion of a soup containing 25 g of protein from pea protein isolate

Pea isolate

Ingestion of a soup containing 25 g of protein from pea protein extrudate

Pea extrudate

Ingestion of a soup containing 25 g of protein from whey protein

Whey

Eligibility Criteria

Age20 Years - 40 Years
Sexall
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 milk protein, pea, celery)
  • 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)
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bonn

Bonn, 53115, Germany

Location

MeSH Terms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Sarah Egert, Prof PhD

    Germany University of Bonn

    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
Sarah Egert, Prof PhD

Study Record Dates

First Submitted

November 7, 2023

First Posted

December 4, 2023

Study Start

January 22, 2024

Primary Completion

June 28, 2024

Study Completion

June 28, 2024

Last Updated

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations