Health Effects of Sustainable Future Proteins

Protein Digestion Kinetics Clinical Trial

— Su-Pro  

Official title:

Health Effects of Sustainable Future Proteins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744221
• Other study ID #: NL65835.081.18
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: December 20, 2018

Study information

• Verified date: November 2018
• Source: Wageningen University and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy subjects

• Age between 35-70 y

• BMI between 18 - 30 kg/m2

Exclusion Criteria:

• Intake of medications known to change the inflammatory status (including proton pump inhibitors, anti-inflammatory medication (including NSAIDs)

• Having a history of medical or surgical events that may significantly affect the study outcome

• Kidney dysfunction (self-reported)

• Gastrointestinal disorders, constipation (defecation <3 times a week) or history of gastrointestinal surgery

• Allergies for our intervention products

• Recent use of antibiotics (<1 month prior to day 01 of the study)

• Not having a general practitioner

• Mental status that is incompatible with the proper conduct of the study

• Pregnancy or lactating

• Reported weight loss or weight gain of > 5 kg in the month prior to pre-study screening

• Reported slimming, medically prescribed, other (extreme) diet, or use of protein concentrates

• Not willing to give up blood donation during the study

• Current smokers

• Alcohol intake > 3 glasses per day

• Hard-drug abuse

• Participation in other clinical trials in the past month

• Being an employee or student of the department Consumer Science & Health group of Wageningen Food & Biobased Research

Related Conditions & MeSH terms

• Intestinal Barrier Function
• Protein Digestion Kinetics

Intervention

Dietary Supplement:
• Corn protein powder
40g/d ( 2 times 20 grams per day for a period of 1 week)
• Bovine plasma protein powder
40g/d ( 2 times 20 grams per day for a period of 1 week)
• Whey protein powder
40g/d ( 2 times 20 grams per day for a period of 1 week)

Locations

Country	Name	City	State
Netherlands	Stichting Wageningen Research	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University and Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in blood pressure	Systolic and diastolic blood pressure	before (Day0) and after (Day7) the protein intervention, under fasting conditions
Other	change in Pulse Wave Analysis	augmentation index	before (Day0) and after (Day7) the protein intervention, under fasting conditions
Other	change in Glucose	Blood markers of metabolic health	before (Day0) and after (Day7) the protein intervention, under fasting conditions and after postprandial protein intake
Other	change in Insulin	Blood markers of metabolic health	before (Day0) and after (Day7) the protein intervention, under fasting conditions and after postprandial protein intake
Other	change in saliva markers	reflecting intestinal health	before (day-1 and day0) and after (day6 and day7) the protein intervention
Primary	Change in gut permeability for total cohort	multi-sugar acetylsalicylic acid test	before (Day-1) and after (Day6) the protein intervention
Primary	Change in blood free amino acids (e.g. Degree of digestibility) on a subset of participants	postprandial test, determine free amino acids in blood samples collected before and after the postprandial challenge test	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
Secondary	change in blood markers of intestinal health,	like diamine oxidase, A1AT, citrulline, FABP-2, CRP or complement,	before (Day0) and after (Day7) the protein intervention, under fasting conditions
Secondary	change in faecal microbiota	obtained from fecal samples	before (Day0) and after (Day7) the protein intervention
Secondary	change in faecal metabolites	obtained from faecal samples	before (Day0) and after (Day7) the protein intervention
Secondary	change in VAS scores on intestinal complains	On a scale ranging from worst-best outcome (higher scores are better)	daily during the intervention from day1 until day7 of the intervention