Completed

NCT Number: NCT03823222

Proteins From Duckweed Trial

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.

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Key information

Conditions

Degree of Digestilbility

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Duckweed protein

Dietary Supplement

20 grams isolated protein

Whey Protein

Dietary Supplement

20 grams isolated protein

Primary outcomes

Change in blood free amino acids (e.g. Degree of digestibility)

Time frame: 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 a postprandial challenge test

Secondary outcomes

change in plasma insulin

Time frame: 20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption

before and after a postprandial challenge test
change in plasma glucose

Time frame: 20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption

before and after a postprandial challenge test

Other outcomes

change in visual analogue scale (VAS) scores on intestinal complains

Time frame: daily from day1 until day3 after the intervention

On a scale ranging from worst-best outcome (higher scores are better)

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Registry information

Acronym: ProDuckT

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Jan 30, 2019
Registry last updated: Apr 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.