- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06618729
Effects of Plant-based Meat Alternatives in Comparison to Chicken Meat on Postprandial Metabolism in Healthy Adults
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North-Rhine Westphalia
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Bonn, North-Rhine Westphalia, Germany, 53115
- University of Bonn, Institute of Nutritional and Food Sciences, Nutritional Physiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pea protein
Participants randomized to receive a meal containing 40 g of protein from pea protein extrudate
|
Ingestion of a meal containing 40 g of protein from pea protein extrudate
|
|
Experimental: Soy protein
Participants randomized to receive a meal containing 40 g of protein from soy protein extrudate
|
Ingestion of a meal containing 40 g of protein from soy protein extrudate
|
|
Active Comparator: Chicken
Participants randomized to receive a meal containing 40 g of protein from chicken meat
|
Ingestion of a meal containing 40 g of protein from chicken
|
|
Experimental: Wheat protein
Participants randomized to receive a meal containing 40 g of protein from wheat protein extrudate
|
Ingestion of a meal containing 40 g of protein from wheat protein extrudate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amino acid profile in urine
Time Frame: Postprandial period of 6 hours
|
Analysis of amino acids in urine (nmol/mL)
|
Postprandial period of 6 hours
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
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Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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)
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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)
|
Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
|
|
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
|
Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180 and 360 minutes)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah Egert, Prof PhD, University of Bonn, Institute of Nutritional and Food Sciences, Nutritional Physiology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AlProPlant-HS2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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