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Completed

NCT Number: NCT06618729

Effects of Plant-based Meat Alternatives in Comparison to Chicken Meat on Postprandial Metabolism in Healthy Adults

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bonn, North Rhine-Westphalia, 53115, Germany

About this study

In a randomized crossover-design, 20 healthy women and men consume 4 test meals containing either 40 g of protein from plant-based meat alternatives (pea, wheat and soy protein extrudate) or chicken 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 (e.g. plasma glucose, serum insulin), lipid metabolism (serum triglycerides, total cholesterol , LDL cholesterol, HDL cholesterol, free fatty acids), serum uric acids, hunger- and satiety-associated gastrointestinal hormones (serum ghrelin, plasma GLP-1), 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 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)
  • hypersensitivity to paracetamol
  • body weight below 50 kg
  • alcohol abuse
  • glucose-6-phosphate dehydrogenase deficiency
  • Gilbert's syndrome
  • eating disorders (especially anorexia nervosa, bulimia nervosa)
  • smoking
  • participation in another study

Treatment and study plan

Pea protein

Other

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

Wheat protein

Other

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

Soy Protein

Other

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

Chicken

Other

Ingestion of a meal containing 40 g of protein from chicken

Primary outcomes

  1. Amino acid profile in blood

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

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

Secondary outcomes

  1. Amino acid profile in urine

    Time frame: Postprandial period of 6 hours

    Analysis of amino acids in urine (nmol/mL)

  2. Urea in blood

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

    Analysis of urea (mg/dL) in blood

  3. Nitrogen in blood

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

    Analysis of nitrogen (mg/dL) in blood

  4. Glucose in blood

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

    Analysis of glucose (mmol/L) in blood

  5. Insulin in blood

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

    Analysis of insulin (pmol/L) in blood

  6. C-peptide in blood

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

    Analysis C-peptide (pg/ml) in blood

  7. Glucagon in blood

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

    Analysis of glucagon (pg/ml) in blood

  8. Uric acid in blood

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

    Analysis of uric acid (mg/dL) in blood

  9. Calcium in blood

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

    Analysis of calcium (mmol/l) in blood

  10. Iron in blood

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

    Analysis of iron (µg/l) in blood

  11. Zinc in blood

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

    Analysis of zinc (µg/l) in blood

  12. Selenium in blood

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

    Analysis of selenium (µg/l) in blood

  13. Copper in blood

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

    Analysis of copper (µg/l) in blood

  14. Triglycerides in blood

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

    Analysis of triglycerides (mmol/l) in blood

  15. Total cholesterol in blood

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

    Analysis of total cholesterol (mmol/l) in blood

  16. LDL cholesterol in blood

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

    Analysis of LDL cholesterol (mmol/l) in blood

  17. HDL cholesterol in blood

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

    Analysis of HDL cholesterol (mmol/l) in blood

  18. Free fatty acids in blood

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

    Analysis of free fatty acids (mmol/L) in blood

  19. Gastric emptying rate

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

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

  20. Ghrelin in blood

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

    Analysis of ghrelin (pg/mL) in blood

  21. GLP-1 in blood

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

    Analysis of GLP-1 (pg/ml) in blood

  22. Hunger/satiety and acceptance of the meals

    Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes)

    Assessment of subjective hunger/satiety and acceptance of the meals by validated visual analogue scale questionnaires (paper-pencil)

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 Plant-based Meat Alternatives Made From Pea, Wheat or Soy Protein in Comparison to Chicken Meat on Postprandial Metabolism in Healthy Women and Men

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Jun 15, 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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