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Completed

NCT Number: NCT06155656

Effects of Pea Proteins With Different Degrees of Processing on Postprandial Metabolism in Healthy Adults

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.

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Key information

Conditions

Plasma Amino Acid Appearance and Disappearance Postprandial Metabolic Events

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bonn

Bonn, 53115, Germany

About this study

In a randomized crossover-design, 20 healthy women and men consume 4 test meals containing either 25 g of protein from plant protein ingredients (pea protein concentrate, isolate, or extrudate) or whey protein together with 1 g paracetamol, which is used as a marker for gastric emptying.

During a postprandial period of 6 hours parameters of protein metabolism (e.g. amino acids in plasma and urine), glucose metabolism (plasma glucose, serum insulin) and gastric emptying rate (based on plasma paracetamol) are analysed. Furthermore, subjective hunger/satiety and acceptance of the meals are assed using visual analogue scales. Each intervention arm will be separated by a washout period of at least 7 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • hypersensitivity to paracetamol
  • body weight below 50 kg
  • alcohol abuse
  • glucose-6-phosphate dehydrogenase deficiency
  • Gilbert's syndrome
  • vegan diet
  • eating disorders (especially anorexia nervosa, bulimia nervosa)
  • smoking
  • participation in another study

Treatment and study plan

Pea protein concentrate

Other

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

Pea protein isolate

Other

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

Pea protein extrudate

Other

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

Whey Protein

Other

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

Primary outcomes

  1. Amino acid profile in blood

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

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

Secondary outcomes

  1. Parameters of protein metabolism in blood I

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

    Analysis of urea (mg/dL and mol/L) in blood

  2. Parameters of protein metabolism in blood II

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

    Analysis of nitrogen (mg/dL) in blood

  3. Parameters of glucose metabolism in blood I

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

    Analysis of glucose (mg/dL and mmol/L) in blood

  4. Parameters of glucose metabolism in blood II

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

    Analysis of insulin (nmol/L and pmol/L) in blood

  5. Gastric emptying rate

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

    Analysis of gastric emptying rate based on paracetamol kinetics in blood (µg/mL)

  6. Hunger/satiety and acceptance of the meals

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

    Assessment of subjective hunger/satiety and acceptance of the meals by validated visual analogue scale questionnaires (e.g., 0 = not hungry at all, 10 = very hungry)

  7. Uric acid in blood

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

    Analysis of uric acid (mg/dL and mmol/L) in blood

  8. Copper in blood

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

    Analysis of copper (µg/l) in blood

  9. Zinc in blood

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

    Analysis of zinc (µg/l) in blood

  10. Iron in blood

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

    Analysis of iron (µg/l) in blood

  11. Selenium in blood

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

    Analysis of selenium (µg/l) in blood

  12. Amino acid profile in urine

    Time frame: Postprandial period of 5 hours

    Analysis of amino acids in urine (nmol/mL)

Sponsors and collaborators

Lead sponsor

University of Bonn

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

Acute Effects of Pea Proteins With Different Degrees of Processing on Postprandial Metabolism in Healthy Women and Men

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2023
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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