Clinical trial NCT06155656: Effects of Pea Proteins With Different Degrees of Processing on Postprandial Metabolism in Healthy Adults
Official title: Acute Effects of Pea Proteins With Different Degrees of Processing 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
name: University of Bonn, Department of Nutrition and Food Sciences, Food Sciences
First posted: 2023-12-04
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 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.

Detailed description: 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.

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 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

Primary outcomes:
measure: Amino acid profile in blood
timeFrame: Postprandial period of 5 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 300 minutes)
Secondary outcomes:
measure: Parameters of protein metabolism in blood I
timeFrame: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
measure: Parameters of protein metabolism in blood II
timeFrame: Postprandial period of 5 hours (Time points: fasting (0) and 60, 120, 180, 240 and 300 minutes)
measure: Parameters of glucose metabolism in blood I
timeFrame: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
measure: Parameters of glucose metabolism in blood II
timeFrame: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
measure: Gastric emptying rate
timeFrame: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
measure: Hunger/satiety and acceptance of the meals
timeFrame: Postprandial period of 5 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 300 minutes)
measure: Uric acid in blood
timeFrame: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
measure: Copper in blood
timeFrame: Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)
measure: Zinc in blood
timeFrame: Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)
measure: Iron in blood
timeFrame: Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)
measure: Selenium in blood
timeFrame: Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)
measure: Amino acid profile in urine
timeFrame: Postprandial period of 5 hours
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn
Study officials:
affiliation: Germany University of Bonn
name: Sarah Egert, Prof PhD
role: PRINCIPAL_INVESTIGATOR
References: