Clinical trial NCT03823222: Proteins From Duckweed Trial
Official title: Proteins From Duckweed Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degree of Digestilbility
Keywords: Duckweed protein
protein
degree of digestibility
whey protein
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to study the digestibility of isolated duckweed protein. The digestibility of the isolated duckweed protein will be compared to an isolated benchmark protein whey.

Objective: The primary objective is to investigate the digestibility of isolated duckweed protein and the isolated benchmark protein whey.

Study design: The study is a cross-over, double blind, controlled trial in which study participants will visit the research facility on two occasions under fasting conditions. Subjects will receive two protein sources in randomized order with a washout period of one week. Blood will be collected via a catheter before and up-to 3 hours after protein consumption.

Study population: We aim to include 12 healthy volunteers aged 18-50 years. Intervention: Study participants will receive 20 grams of isolated duckweed protein and the isolated benchmark protein whey.

Main study parameters/endpoints: The main study parameter is blood amino acids measured before and after consumption of 20 g protein.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18 and 25 kg/m2
* Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor)

Exclusion Criteria:

* Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease)
* History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
* History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
* Kidney dysfunction (self-reported)
* Use of medication that may influence the study results, such as gastric acid inhibitors, laxatives, stomach protectors and drugs that can affect intestinal motility
* Anaemia (Hb values \<7.5 for women and \<8.5 for men)
* Reported slimming, medically prescribed, vegan/vegetarian or other extreme diets or the 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 illicit drugs
* Food allergies for products that we use in the study
* Participation in another clinical trial at the same time
* Being an employee of the department Consumer Science \& Health group of Wageningen Food \& Biobased Research

Primary outcomes:
measure: Change in blood free amino acids (e.g. Degree of digestibility)
timeFrame: 20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption
Secondary outcomes:
measure: change in plasma insulin
timeFrame: 20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption
measure: change in plasma glucose
timeFrame: 20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption
Other outcomes:
measure: change in visual analogue scale (VAS) scores on intestinal complains
timeFrame: daily from day1 until day3 after the intervention
Locations:
city: Wageningen
country: Netherlands
facility: Stichting Wageningen Research
state: Gelderland
Study officials:
affiliation: Wageningen Research
name: Diederik Esser, PhD
role: PRINCIPAL_INVESTIGATOR
References: