Promephy - Metabolic Fate of Plant-based Proteins

The PROMEPHY study aims to assess differences between animal versus plant-based proteins on metabolic and physiological parameters in healthy adults. It is envisaged that the results from this study will provide important and novel insights into the potential health-benefits of regular consumption of plant-based proteins. This may enable future application in products available to the consumer.The main objective of this study is to compare the changes in serum essential amino acid bioavailability after two weeks of daily consumption of a plant-based protein mix with the changes in serum essential amino acid bioavailability after two weeks of daily consumption of a milk protein isolate. In addition this study will aim to assess the impact of different protein sources on gut microbiota and proteome composition to determine the potential health impact of consumption of plant-based proteins.

Inclusion Criteria:Age ≥ 18 and ≤ 50 yearsBody Mass Index (BMI) ≥ 18.5 and ≤ 24.9 kg/m2Written informed consentWillingness and ability to comply with the protocolWillingness to use a method of birth control during participation in the study (women only)Judged by the investigator to be in good healthExclusion Criteria:Any known ongoing medical condition that interferes significantly with absorption and digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, celiac disease, diaphragmatic hernia or diaphragmatic surgery, gastric ulcer, gastritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery), in opinion of the investigator.Known cardiovascular disease, disease related to the immune system and/or the respiratory systemKnown renal or hepatic failure or known thyroid dysfunctionKnown Diabetes Mellitus type I or type IIAny ongoing cancer (except for basal cell carcinoma) and/ or cancer treatmentHaemoglobin (Hb) in men <7.5 mmol/l and in women <7.0 mmol/l at screeningAny known bleeding disorderUse of oral and systemic use of prokinetics, laxatives, antidiarrheals, anticoagulants within 3 weeks of Visit 1Use of antibiotics within 3 months prior to Visit 1Known lactose intolerance or known plant-based protein allergyAdherence to a strict dietary regime (e.g. vegetarian/ vegan/ paleo/ketogenic/high protein diet or a weight loss program)Use of any nutritional supplements or additional protein supplements or nutritional support within 6 weeks prior to visit 1Regular heavy and/or extreme exercise (e.g. trained elite athletes) in opinion of the investigatorKnown pregnancy and/or lactation (women only)Current smoking or stopped smoking for < 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/cigars/pipes per week on average in the last month) and willingness to stop entirely during study participation (after enrolment).Average alcohol use of > 21 glasses per week for men or > 14 glasses per week for women (on average during the last 6 months) or drug/ medicine abuse in opinion of the investigatorParticipation in any other clinical study with investigational or marketed products concomitantly or within four weeks before study visit 1Major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the investigatorInvestigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements