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ID
Source
Brief title
Health condition
Postprandial metabolism of protein in healthy volunteers
Verteringskinetiek van eiwit bij gezonde mensen
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum amino acids
Secondary outcome
Serum glucose, insulin (t=0 until t=180; each 15-30 minutes)
Gastro-intestinal complaints (during 4 days)
Background summary
The 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.
Study objective
• 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.
Study design
Eleven blood samples are taken each 15-30 minutes for a period of 3 hours.
Gastro-intestinal complaints during 4 days.
Intervention
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.
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
• 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)
• 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL6194 |
| NTR-old | NTR6516 |
| Other | ABR / METC Wageningen number : 62305.081.17 / 17/13 |