Status:
COMPLETED
Postprandial Blood Amino Acid Response
Lead Sponsor:
NIZO Food Research
Collaborating Sponsors:
FrieslandCampina
Conditions:
Protein Digestion Kinetics
Eligibility:
All Genders
18-65 years
Phase:
NA
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03313791
Start Date
October 25 2017
End Date
May 2 2018
Last Update
September 5 2018
Active Locations (1)
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1
NIZO
Ede, Netherlands