Clinical trial NCT03313791: Postprandial Blood Amino Acid Response
Official title: Postprandial Blood Amino Acid Concentrations After Dairy Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Digestion Kinetics
Lead sponsor: NIZO Food Research
Sponsor class: OTHER
Collaborators: name: FrieslandCampina
First posted: 2017-10-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 groups of 10 subjects both receive a different set of 6 different dairy products. Each subject within a group will receive all treatments on the same day of the week with a 1 week washout period between treatments. Results of the two groups will be analyzed separately, and products will only be compared within the same group of subjects, treating the data as two independent studies.
Primary purpose: BASIC_SCIENCE

Brief summary: This study was designed to obtain information about the change in postprandial amino acids in blood over time, after consumption of different dairy products with varying proportions of whey protein and caseins, and different processing conditions.


Eligibility criteria: Inclusion Criteria:

* Age 18-65y
* BMI 18.5-30 kg/m2
* Non-smoking
* Healthy as assessed by the NIZO lifestyle and health questionnaire ("Verklaring leefgewoonten en gezondheid") and according to the judgment of the study physician.".
* Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day)
* Veins suitable for cannulation (blood sampling)
* Voluntary participation
* Having given written informed consent
* Willing to comply with study procedures
* Accept use of all encoded data, including publication, and the confidential use and storage of all data for 15 years.
* Accept disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria:

* Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before Day 01 of this study
* 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
* Use of the following medication: glucose lowering drugs, insulin; medication that may impact gastric emptying (e.g. gastric acid inhibitors or laxatives)
* Diagnosed with diabetes, being treated for high blood glucose or increased fasting blood glucose (\> 7 mmol/l in finger prick blood) as assessed during screening visit
* For men: Hb \<8,5 mmol/l as assessed during screening visit; for women: Hb \<7,5 mmol/l.
* Use of protein supplements
* Mental status that is incompatible with the proper conduct of the study
* A self-reported reported food allergy or sensitivity to dairy ingredients
* Alcohol consumption for men \> 28 units/week and \>4/day; for women: \>21 units/week and \>3/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
* Reported slimming or medically prescribed diet
* Recent blood donation (\<1 month prior to Day 01 of the study)
* Not willing or afraid to give up blood donation during the study
* Personnel of NIZO food research, FrieslandCampina Research, or Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
* Not having a general practitioner
* Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results and eventual adverse events to and from his general practitioner
* Self reported pregnancy or breastfeeding

Primary outcomes:
measure: iAUC for postprandial individual plasma amino acids
timeFrame: Time Frame: 0-300 min after consumption
measure: Cmax for postprandial individual plasma amino acids
timeFrame: Time Frame: 0-300 min after consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Ede
country: Netherlands
facility: NIZO
Study officials:
affiliation: NIZO Food Research
name: Alwine Kardinaal, PhD
role: PRINCIPAL_INVESTIGATOR
References: