Health Effects of Sustainable Future Proteins

NCT03744221 | Completed

• 1 other identifier: NL65835.081.18
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intestinal Barrier Function; Protein Digestion Kinetics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• change in blood markers of intestinal health,

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

• change in faecal microbiota

  before (Day0) and after (Day7) the protein intervention

• change in faecal metabolites

  before (Day0) and after (Day7) the protein intervention

• change in VAS scores on intestinal complains

  daily during the intervention from day1 until day7 of the intervention

Other Outcomes (5)

• change in blood pressure

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

• change in Pulse Wave Analysis

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

• change in Glucose

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

Study Arms (3)

Corn protein

EXPERIMENTAL

Corn protein powder

Dietary Supplement: Corn protein powder

Bovine plasma protein

EXPERIMENTAL

Bovine plasma protein powder

Dietary Supplement: Bovine plasma protein powder

control benchmark protein Whey

ACTIVE COMPARATOR

Whey protein powder

Dietary Supplement: Whey protein powder

Interventions

Corn protein powder DIETARY_SUPPLEMENT

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

Also known as: sustainable protein source 1

Corn protein

Bovine plasma protein powder DIETARY_SUPPLEMENT

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

Also known as: sustainable protein source 2

Bovine plasma protein

Whey protein powder DIETARY_SUPPLEMENT

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

Also known as: control protein source

control benchmark protein Whey

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects
• Age between 35-70 y
• BMI between 18 - 30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University and Research: lead

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

Study Officials

• Diederik Esser, Dr

  Wageningen research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Proteins will be packed in non-transparent sealed sachets/jars and labeled with 'protein A/B/C'. Proteins will be flavored to mask taste
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: project leader clinical trials

Model Details: 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. 12 subjects will also receive an acute postprandial digestibility test at the start of the intervention.

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 16, 2018
• Study Start: November 5, 2018
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: January 16, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)