The primary objective is to estimate differences in postprandial plasma total essential amino acids (TEAA) profiles after protein consumption, determined by appearance (profiling, iAUC and peak Cmax), between pea, faba, casein, and whey in blood of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
opname van aminozuren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the postprandial profile (iAUC and peak Cmax) of
total essential amino acids (TEAA) before and after consumption of pea, faba,
casein, and whey.
Secondary outcome
Other study parameters include total and individual (essential) amino acid
profiles (iAUC, peak Cmax, and Time-2-max) before and after consumption of pea,
pea+methionine, pea+casein, faba, casein, and whey.
Background summary
To optimize the environmental sustainability, a protein transition to more
plant-based protein sources is required. However, the protein quality of
plant-based sources is lower than that of the dairy proteins casein and whey,
which contain high levels of essential amino acids. The amino acid absorption
characteristics of many plant-based proteins are unknown. Pea protein and faba
protein could be very promising ingredients. Effect sizes obtained in this
explorative study will gain valuable insights for future follow-up studies.
Study objective
The primary objective is to estimate differences in postprandial plasma total
essential amino acids (TEAA) profiles after protein consumption, determined by
appearance (profiling, iAUC and peak Cmax), between pea, faba, casein, and whey
in blood of healthy participants. The secondary objectives are 1) To estimate
differences in postprandial plasma total and individual essential amino acids
(individual EAA) profiles after protein consumption, determined by appearance
(profiling, iAUC and peak Cmax), between casein, whey, faba, pea in blood of
healthy participants, 2) To explore differences in effect sizes of postprandial
plasma total (essential) amino acids (individual EAA, TEAA and TAA) profiles
after protein consumption, determined by appearance (profiling, iAUC and peak
Cmax), between casein, whey, faba, pea, pea-casein, and pea-methionine measured
in blood of healthy participants, and 3) To estimate differences in
postprandial plasma non-essential amino acids (individual AA) profiles after
protein consumption, determined by appearance (profiling, iAUC and peak Cmax),
between casein, whey, faba, pea, pea-casein, and pea-methionine measured in
blood of healthy participants.
Study design
This explorative study has a randomized, cross-over, double-blind, controlled
design.
Intervention
During each visit, research subjects will receive one of the six protein blends
(whey protein, casein protein, faba protein, pea protein, pea protein + casein
protein, pea protein + methionine) dissolved in water, representing a 20g
protein load, in randomized order.
Study burden and risks
This study is not related to a specific group. There are minor risks for the
research subjects of this study. There are no direct benefits for the research
subjects. In this study, we will include healthy research subjects based on the
study criteria and a health questionnaire. The total amount of blood collected
(492ml ) is spread over at least six weeks and we will exclude subjects with
anemia. Blood collection will therefore not be expected to cause any problems.
Research subjects that will participate in the study will invest approximately
49 hours during the trial.
Stationsplein 4
Amersfoort 3818 LE
NL
Stationsplein 4
Amersfoort 3818 LE
NL
Listed location countries
Age
Inclusion criteria
• Apparently healthy men and women;
• Age >=18 and <=40 years;
• Body mass index (BMI) >=18.5 and <=30 kg/m2 ;
• Having veins suitable for blood sampling via a catheter (judged by study
nurse/ medical doctor).
Exclusion criteria
• Any self-reported metabolic, gastrointestinal, inflammatory or chronic
disease (such as anemia, diabetes, hepatitis, cardiovascular disease);
• Having a history of medical or surgical events that may significantly affect
the study outcome, including: Inflammatory bowel disease, hepatitis,
pancreatitis, ulcers, gastrointestinal or rectal bleeding; major
gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel
resection; known or suspected gastrointestinal disorders, colon or GI tract
cancer;
• Anaemia (Haemoglobin (Hb) values <7.5 mmol/L for women and <8.5 mmol/L for
men), as assessed by finger prick blood during screening visit;
• Having a food allergy, cow*s milk protein, soy or bean protein allergy,
favism (G6PD-deficiency), and/or lactose intolerance (self-reported);
• Use of glucose lowering drugs, insulin;
• Use of medication that may impact gastric emptying (e.g. gastric acid
inhibitors or laxatives);
• Use of antibiotic treatment less than 1 month before start of the study and
during the study;
• Use of anti-depressives as a treatment for depression;
• Use of protein supplements (must be stopped 1 week before the first test
day);
• Reported weight loss or weight gain of > 3 kg in the month prior to pre-study
screening, or intention to lose weight during the study period;
• Reporting to follow or having planned a slimming or medically prescribed diet.
• Not willing to keep a stable lifestyle during the study period;
• Recent blood donation (<1 month prior to test day 1 of the study) or not
willing to stop donation during and 1 month after the study;
• Average alcohol intake >21 (women) or >28 (men) glasses of alcoholic
beverages per week;
• Use of drugs;
• Current smokers;
• Pregnant, lactating or wishing to become pregnant in the period of the study
(self-reported);
• Not having a general practitioner;
• Insufficient proficiency in Dutch to understand information brochure and
questionnaires;
• Participation in any clinical trial including blood sampling and/or
administration of substances up to 30 days before test day 1 of this study;
• Being an employee of the department Food, Health & Consumer Research of
Wageningen Food & Biobased Research or FrieslandCampina R&D.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83659.091.23 |
| Other | NL83659.091.23 |