Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG, Netherlands
NCT Number: NCT03744221
In the current study the investigators aim to assess the nutritional quality and bio-functional activity of two alternative protein sources bovine plasma and corn and from the benchmark protein whey. The study is a double blind, randomised, cross-over, short-term trial in which 36 healthy study subjects will receive three protein interventions of 1 week with a washout period of 1 week between interventions. Study subjects will visit the research facility before and after the intervention period on two separate occasions to measure gut permeability via a multi-sugar test and to collect fasting blood samples and blood pressure outcomes. Faecal and saliva samples before and after each intervention will be collected. A subgroup of 12 study participants will also be subjected to a postprandial digestibility test on the first day of the interventions. The main study parameter is to assess the protein digestion kinetics and protection of the epithelial barrier. Secondary study parameters include other markers of gastrointestinal health, metabolic health, vascular health and satiating properties.
Looking for future studies?
Notify Me35 year–70 year
All sexes
Interventional
Not applicable
Wageningen, Gelderland, 6708 WG, Netherlands
In the current study the investigators aim to assess the nutritional quality and bio-functional activity of two alternative protein sources bovine plasma and corn and from the benchmark protein whey. The objective is to assess the degree of digestibility and protection of the epithelial barrier of two alternative protein concentrates from corn and bovine plasma and of the commonly consumed benchmark protein whey. These outcomes will also be used to evaluate how predictive the in vitro-measurements have been for the obtained in vivo-effects. Secondary objectives are to assess the impact on other markers of gastrointestinal health, metabolic health, vascular health and satiating properties. Study design: The study is a double blind, randomised, cross-over, short-term trial in which 36 study subject will participate. Study subjects will receive three protein interventions of 1 week with a washout period of 1 week between interventions. Study subjects will visit the research facility before and after the intervention period on two separate occasions to measure gut permeability via a multi-sugar/acetylsalicylic acid test and to collect fasting blood samples and blood pressure outcomes. Faecal and saliva samples before and after each intervention will be collected. All measurements will be conducted after an overnight fast and a standardised evening meal prior to the study days. A subgroup of 12 study participants will also be subjected to a postprandial digestibility test on the first day of the interventions.
Study population: healthy study subjects, between 35-70y, BMI 18 - 30kg/m2, both males and females.
Intervention (if applicable): Three intervention arms of one week; a bovine plasma protein intervention, a corn protein intervention and a whey protein comparator intervention. Study subjects will receive 40 grams of protein per day during the intervention in two 20 g doses.
Main study parameters/endpoints: The main study parameter is to assess the protein digestion kinetics and protection of the epithelial barrier. Secondary study parameters include other markers of gastrointestinal health, metabolic health, vascular health and satiating properties.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
40g/d ( 2 times 20 grams per day for a period of 1 week)
Other names: sustainable protein source 1
40g/d ( 2 times 20 grams per day for a period of 1 week)
Other names: sustainable protein source 2
40g/d ( 2 times 20 grams per day for a period of 1 week)
Other names: control protein source
Time frame: before (Day-1) and after (Day6) the protein intervention
multi-sugar acetylsalicylic acid test
Time frame: before (Day0) each intervention, 20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption
postprandial test, determine free amino acids in blood samples collected before and after the postprandial challenge test
Time frame: before (Day0) and after (Day7) the protein intervention, under fasting conditions
like diamine oxidase, A1AT, citrulline, FABP-2, CRP or complement,
Time frame: before (Day0) and after (Day7) the protein intervention
obtained from fecal samples
Time frame: before (Day0) and after (Day7) the protein intervention
obtained from faecal samples
Time frame: daily during the intervention from day1 until day7 of the intervention
On a scale ranging from worst-best outcome (higher scores are better)
Time frame: before (Day0) and after (Day7) the protein intervention, under fasting conditions
Systolic and diastolic blood pressure
Time frame: before (Day0) and after (Day7) the protein intervention, under fasting conditions
augmentation index
Time frame: before (Day0) and after (Day7) the protein intervention, under fasting conditions and after postprandial protein intake
Blood markers of metabolic health
Time frame: before (Day0) and after (Day7) the protein intervention, under fasting conditions and after postprandial protein intake
Blood markers of metabolic health
Time frame: before (day-1 and day0) and after (day6 and day7) the protein intervention
reflecting intestinal health
Wageningen University and Research
Other
Acronym: Su-Pro
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.
Published trials that share one or more normalized conditions with this study.
NCT03611400
Intestinal Barrier Function
Gainesville, Florida, United States
View Trial DetailsNCT01686204
Body Weight, Chronic Inflammation
Madison, Wisconsin, United States
View Trial DetailsNCT03313791
Protein Digestion Kinetics
Ede, Netherlands
View Trial DetailsNCT03547362
Protein Digestion Kinetics
Ede, Gelderland, Netherlands
View Trial Details