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Measuring the nutritional quality of duckweed protein in comparison with green pea protein in healthy volunteers


- candidate number27390
- NTR NumberNTR6516
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jun-2017
- Secondary IDs62305.081.17 / 17/13 ABR / METC Wageningen number
- Public TitleMeasuring the nutritional quality of duckweed protein in comparison with green pea protein in healthy volunteers
- Scientific TitleAmino acid profile and post-ingestive consequences of duckweed protein (Lemnae minor) after a single intake with pea protein as reference
- ACRONYMPro-2-study
- hypothesis The amino acid profile of duckweed derived protein may be different from pea derived protein.
The glucose and insulin responses of duckweed protein may be different compared to those of pea protein.
A single intake of duckweed and pea protein will give no negative effects in acute health parameters.
The number of gastro-intestinal complaints after a single intake of duckweed may be different compared to the number of gastro-intestinal complaints after a single intake of pea protein.
- Healt Condition(s) or Problem(s) studiedDigestion, Protein, Healthy subjects
- Inclusion criteria Healthy as assessed by a health and lifestyle questionnaire and normal blood clinical laboratory tests for haemoglobin, kidney and liver functioning
Age between 18 and 50 y (boundaries included) at day 01 of the study
Body mass index (BMI) between 19 and 25 kg/m2 (boundaries included)
Appropriate veins for blood sampling (judged by a study nurse or medical doctor)
Willing to abstain from blood donation one month before and during the study
Willing to abstain from the use of protein supplements during the study period
Voluntary participation
Signed informed consent
Willing to comply with the study procedures
- Exclusion criteria Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease)
History of gastro-intestinal surgery
History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
Kidney dysfunction (eGFR <60 ml/min)
Thromboembolic disorders
Any concomitant medication that may influence the study results, such as gastric acid inhibitors or laxatives (occasional use of paracetamol is allowed)
Intensive sporting activities (>16 hours per week)
Current smoker
Alcohol intake≥ 40 gram/ day (≥3 glasses of beer/wine per day)
Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
Use of hard drugs
Known allergies towards the products used in the study
Participation in another clinical trial at the same time
Being an employee of the responsible and executing research facility
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-nov-2017
- planned closingdate11-nov-2017
- Target number of participants15
- InterventionsSubjects come to the research facility in fasting state twice to consume a soup with duckweed or a soup with pea. After consumption, blood samples will be taken each 15 minutes for a period of three hours to assess the free amino acids as well as glucose and insulin levels to get insight into the post-prandial metabolism of the two plant proteins.
- Primary outcomeSerum amino acids
- Secondary outcomeSerum glucose, insulin (t=0 until t=180; each 15 minutes)
Gastro-intestinal complaints (during 4 days)
- TimepointsBlood samples are taken each 15 minutes for a period of 3 hours.
Gastro-intestinal complaints during 4 days.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Jurriaan Mes
- CONTACT for SCIENTIFIC QUERIES Jurriaan Mes
- Sponsor/Initiator Wageningen Food & Biobased Research
- Funding
(Source(s) of Monetary or Material Support)
Wellcome trust
- Publications
- Brief summaryThe primary objective of this cross-over study is to assess the post-prandial serum amino-acid profile of duckweed protein in 15 healthy adult volunteers in comparison to a another plant-based high-protein crop: green pea. A secondary objective is to assess post-prandial plasma glucose and insulin responses after a single intake of duckweed protein in healthy adult volunteers in comparison with the reference pea protein, as well as the acute health parameters heart rate, blood pressure and aural temperature and the occurrence of gastro-intestinal complaints.
- Main changes (audit trail)7-okt-2017 -IK:

Inclusion criteria:
Removal of " Voluntary participation"


Exclusion criteria:
Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease)
History of gastro-intestinal surgery
History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
Kidney dysfunction (eGFR <60 ml/min)
Thromboembolic disorders
Any concomitant medication that may influence the study results, such as gastric acid inhibitors or laxatives (occasional use of paracetamol is allowed)
Intensive sporting activities (>16 hours per week)
Current smoker
Alcohol intake≥ 40 gram/ day (≥3 glasses of beer/wine per day)
Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
Use of hard drugs
Known allergies towards the products used in the study
Participation in another clinical trial at the same time
Being an employee of the responsible and executing research facility

replaced by

Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease)
History of gastro-intestinal surgery
History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
Kidney dysfunction (eGFR <60 ml/min)
Any concomitant medication that may influence the study results, such as gastric acid inhibitors or laxatives (occasional use of paracetamol is allowed)
Intensive sporting activities (>16 hours per week)
Current smoker
Alcohol intake (≥3 glasses of alcoholic beverages per day)
Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
Use of hard drugs
Known allergies towards the products used in the study
Not willing to consume chicken broth
Participation in another clinical trial at the same time
Being an employee of the responsible and executing research facility


Study type:
"Intervention" replaced by "observational study with invasive measurements".


Interventions:
"Subjects come to the research facility in fasting state twice to consume a soup with duckweed or a soup with pea. After consumption, blood samples will be taken each 15 minutes for a period of three hours to assess the free amino acids as well as glucose and insulin levels to get insight into the post-prandial metabolism of the two plant proteins."

replaced by

"Subjects come to the research facility in fasting state twice to consume a soup with duckweed or a soup with pea. Two blood samples will be drawn before consumption. After consumption, blood samples will be taken 9 times (each 15-30 minutes) for a period of three hours to assess the free amino acids as well as glucose and insulin levels to get insight into the post-prandial metabolism of the two plant proteins."


Secondary outcome:
"Serum glucose, insulin (t=0 until t=180; each 15 minutes)
Gastro-intestinal complaints (during 4 days)"

replaced by

"Serum glucose, insulin (t=0 until t=180; each 15-30 minutes)
Gastro-intestinal complaints (during 4 days)"


Timepoints:
"Blood samples are taken each 15 minutes for a period of 3 hours.
Gastro-intestinal complaints during 4 days."

replaced by

"Eleven blood samples are taken each 15-30 minutes for a period of 3 hours.
Gastro-intestinal complaints during 4 days."
- RECORD15-jun-2017 - 12-okt-2017


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