Personal Protein Digestion Variability

NCT05118412 | Completed

• 1 other identifier: NL 77937.041.21
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to quantify the variation in postprandial AA profiles between (and within) individuals after consumption of a poorly digestible plant protein source (Lucerne) and to compare the variation in postprandial AA profiles between a poorly digestible plant protein source and an easy digestible protein source (whey). The study has a randomised, cross-over, controlled design. Two different treatments, all representing a 20g protein load, will be evaluated on five occasions with a washout period of minimum one week between the test days. On test days, research subjects will receive two different protein sources, in the form of a protein drink, in randomised order; on three test days they will receive a poor-digestible protein source, on two test days an easily digestible protein source. Blood will be collected via a catheter before and up-to four hours after protein consumption. Wellbeing, health complaints or other adverse effects will be collected via short questionnaires during each test day. After each test day gastrointestinal complaints will be collected via an online questionnaire.

Conditions

Digestive System

Keywords

Plant protein; Digestibility; Protein digestion kinetics; Personalized digestibility; Lucerne

Outcome Measures

Primary Outcomes (10)

• Personal variability in 19 amino acid uptake kinetics

  Plasma 19 free amino acid levels in venous blood samples under fasting conditions.

  Baseline

• Personal variability in 19 amino acid uptake kinetics

  Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  15 minutes post ingestion

• Personal variability in 19 amino acid uptake kinetics

  Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  30 minutes post ingestion

• Personal variability in 19 amino acid uptake kinetics

  Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  45 minutes post ingestion

• Personal variability in 19 amino acid uptake kinetics

  Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  60 minutes post ingestion

• Personal variability in 19 amino acid uptake kinetics

  Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  90 minutes post ingestion

• Personal variability in 19 amino acid uptake kinetics

  Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  120 minutes post ingestion

• Personal variability in 19 amino acid uptake kinetics

  Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  150 minutes post ingestion

• Personal variability in 19 amino acid uptake kinetics

  Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  180 minutes post ingestion

• Personal variability in 19 amino acid uptake kinetics

  Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  240 minutes post ingestion

Secondary Outcomes (3)

• Self-reported gastro-intestinal complaints

  Before dinner, at the end of each study day

• Self-reported gastro-intestinal complaints

  Before dinner, first day after each study day.

• Self-reported gastro-intestinal complaints

  Before dinner, second day after each study day.

Study Arms (2)

Lucerne protein concentrate

EXPERIMENTAL

Lucerne protein concentrate powder presented in the form of a shake.

Other: Lucerne protein concentrate shake

Whey protein concentrate

EXPERIMENTAL

Whey protein concentrate powder presented in the form of a shake.

Other: Whey protein concentrate shake

Interventions

Lucerne protein concentrate shake OTHER

At three out of five test days: Lucerne protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.

Also known as: Alfalfa protein concentrate shake

Lucerne protein concentrate

Whey protein concentrate shake OTHER

At two out of five test days: Whey protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.

Whey protein concentrate

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Apparently healthy men and women;
• Age between 18 and 40 years;
• Body mass index (BMI) between 18.5 and 30 kg/m2 ;
• Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor).

You may not qualify if:

• Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease),or having a condition or disease that may lead to an impaired immune system;
• History of gastrointestinal surgery or having (serious) gastrointestinal complaints;
• History of liver dysfunction (cirrhosis, hepatitis) or liver surgery;
• Kidney dysfunction (self-reported);
• Any use of medication that may suppress the immune system, this will be judged by the medical supervisor;
• Use of medication that may influence the study results, such as gastric acid inhibitors, laxatives, stomach protectors and drugs that can affect intestinal motility, this will be judged by the medical supervisor;
• Anaemia (Hb values \<7.5 mmol/L for women and \<8.5 mmol/L for men);
• Reported slimming, medically prescribed or other extreme diets;
• Use of protein supplements;
• Not willing to give up blood donation during the study;
• Current smokers;
• Alcohol intake ≥4 glasses of alcoholic beverages per day;
• Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported);
• Abuse of hard drugs;
• Not having a general practitioner;

Sponsors & Collaborators

• Wageningen University and Research: lead

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

Study Officials

• Diederik Esser, PhD

  Wageningen University and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader clinical trials

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 12, 2021
• Study Start: October 26, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)