Clinical trial NCT06618729: Effects of Plant-based Meat Alternatives in Comparison to Chicken Meat on Postprandial Metabolism in Healthy Adults
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plasma Amino Acid Appearance and Disappearance
Postprandial Metabolic Events
Keywords: Postprandial metabolic events
Lead sponsor: University of Bonn
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2024-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Detailed description: 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.

Eligibility criteria: 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\&#39;s syndrome
* eating disorders (especially anorexia nervosa, bulimia nervosa)
* smoking
* participation in another study

Primary outcomes:
measure: Amino acid profile in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Secondary outcomes:
measure: Amino acid profile in urine
timeFrame: Postprandial period of 6 hours
measure: Urea in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
measure: Nitrogen in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
measure: Glucose in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
measure: Insulin in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
measure: C-peptide in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120 and 360 minutes)
measure: Glucagon in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
measure: Uric acid in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
measure: Calcium in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
measure: Iron in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
measure: Zinc in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
measure: Selenium in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
measure: Copper in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
measure: Triglycerides in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
measure: Total cholesterol in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
measure: LDL cholesterol in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
measure: HDL cholesterol in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
measure: Free fatty acids in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
measure: Gastric emptying rate
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
measure: Ghrelin in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
measure: GLP-1 in blood
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180 and 360 minutes)
measure: Hunger/satiety and acceptance of the meals
timeFrame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes)
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn, Institute of Nutritional and Food Sciences, Nutritional Physiology
state: North-Rhine Westphalia
Study officials:
affiliation: University of Bonn, Institute of Nutritional and Food Sciences, Nutritional Physiology
name: Sarah Egert, Prof PhD
role: PRINCIPAL_INVESTIGATOR
References: