Proteins From Duckweed Trial
ProDuckT
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedStudy Start
First participant enrolled
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2019
CompletedApril 16, 2019
April 1, 2019
28 days
January 29, 2019
April 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in blood free amino acids (e.g. Degree of digestibility)
postprandial test, determine free amino acids in blood samples collected before and after a postprandial challenge test
20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption
Secondary Outcomes (2)
change in plasma insulin
20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption
change in plasma glucose
20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption
Other Outcomes (1)
change in visual analogue scale (VAS) scores on intestinal complains
daily from day1 until day3 after the intervention
Study Arms (2)
Duckweed protein
EXPERIMENTAL20 gram of isolated protein
Whey protein
EXPERIMENTAL20 gram of isolated protein
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diederik Esser, PhD
Wageningen Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- project leader clinical trials
Study Record Dates
First Submitted
January 29, 2019
First Posted
January 30, 2019
Study Start
February 28, 2019
Primary Completion
March 28, 2019
Study Completion
March 28, 2019
Last Updated
April 16, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share
will not be shared