Health Effects of Sustainable Future Proteins (Su-Pro)

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.

Study Overview

• Status: Completed
• Conditions: Protein Digestion Kinetics; Intestinal Barrier Function
• Intervention / Treatment: Dietary supplement: Corn protein powder; Dietary supplement: Bovine plasma protein powder; Dietary supplement: Whey protein powder

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WG
      • Stichting Wageningen Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corn protein; Corn protein powder	Dietary supplement: Corn protein powder; 40g/d ( 2 times 20 grams per day for a period of 1 week); Other Names: sustainable protein source 1
Experimental: Bovine plasma protein; Bovine plasma protein powder	Dietary supplement: Bovine plasma protein powder; 40g/d ( 2 times 20 grams per day for a period of 1 week); Other Names: sustainable protein source 2
Active Comparator: control benchmark protein Whey; Whey protein powder	Dietary supplement: Whey protein powder; 40g/d ( 2 times 20 grams per day for a period of 1 week); Other Names: control protein source

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gut permeability for total cohort	multi-sugar acetylsalicylic acid test	before (Day-1) and after (Day6) the protein intervention
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
change in faecal microbiota	obtained from fecal samples	before (Day0) and after (Day7) the protein intervention
change in faecal metabolites	obtained from faecal samples	before (Day0) and after (Day7) the protein intervention
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in blood pressure	Systolic and diastolic blood pressure	before (Day0) and after (Day7) the protein intervention, under fasting conditions
change in Pulse Wave Analysis	augmentation index	before (Day0) and after (Day7) the protein intervention, under fasting conditions
change in Glucose	Blood markers of metabolic health	before (Day0) and after (Day7) the protein intervention, under fasting conditions and after postprandial protein intake
change in Insulin	Blood markers of metabolic health	before (Day0) and after (Day7) the protein intervention, under fasting conditions and after postprandial protein intake
change in saliva markers	reflecting intestinal health	before (day-1 and day0) and after (day6 and day7) the protein intervention

Collaborators and Investigators

• Sponsor: Wageningen University and Research

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: November 2, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NL65835.081.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No