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Completed

NCT Number: NCT03744221

Health Effects of Sustainable Future Proteins

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.

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corn protein powder

Dietary Supplement

40g/d ( 2 times 20 grams per day for a period of 1 week)

Other names: sustainable protein source 1

Bovine plasma protein powder

Dietary Supplement

40g/d ( 2 times 20 grams per day for a period of 1 week)

Other names: sustainable protein source 2

Whey protein powder

Dietary Supplement

40g/d ( 2 times 20 grams per day for a period of 1 week)

Other names: control protein source

Primary outcomes

  1. Change in gut permeability for total cohort

    Time frame: before (Day-1) and after (Day6) the protein intervention

    multi-sugar acetylsalicylic acid test

  2. Change in blood free amino acids (e.g. Degree of digestibility) on a subset of participants

    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

Secondary outcomes

  1. change in blood markers of intestinal health,

    Time frame: before (Day0) and after (Day7) the protein intervention, under fasting conditions

    like diamine oxidase, A1AT, citrulline, FABP-2, CRP or complement,

  2. change in faecal microbiota

    Time frame: before (Day0) and after (Day7) the protein intervention

    obtained from fecal samples

  3. change in faecal metabolites

    Time frame: before (Day0) and after (Day7) the protein intervention

    obtained from faecal samples

  4. change in VAS scores on intestinal complains

    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)

Other outcomes

  1. change in blood pressure

    Time frame: before (Day0) and after (Day7) the protein intervention, under fasting conditions

    Systolic and diastolic blood pressure

  2. change in Pulse Wave Analysis

    Time frame: before (Day0) and after (Day7) the protein intervention, under fasting conditions

    augmentation index

  3. change in Glucose

    Time frame: before (Day0) and after (Day7) the protein intervention, under fasting conditions and after postprandial protein intake

    Blood markers of metabolic health

  4. change in Insulin

    Time frame: before (Day0) and after (Day7) the protein intervention, under fasting conditions and after postprandial protein intake

    Blood markers of metabolic health

  5. change in saliva markers

    Time frame: before (day-1 and day0) and after (day6 and day7) the protein intervention

    reflecting intestinal health

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Registry information

Acronym: Su-Pro

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 16, 2018
Registry last updated
Jan 16, 2019

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.

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