Degree of Digestilbility Clinical Trial
— ProDuckTOfficial title:
Proteins From Duckweed Trial
| Verified date | April 2019 |
| Source | Wageningen University and Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | March 28, 2019 |
| Est. primary completion date | March 28, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Stichting Wageningen Research | Wageningen | Gelderland |
| Lead Sponsor | Collaborator |
|---|---|
| Wageningen University and Research |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | change in visual analogue scale (VAS) scores on intestinal complains | On a scale ranging from worst-best outcome (higher scores are better) | daily from day1 until day3 after the intervention | |
| Primary | 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 | change in plasma insulin | 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 | change in plasma glucose | 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 |