Real-time Amino acid Profiling 2
- Conditions
- Protein Digestion Kinetics
- Registration Number
- NL-OMON28579
- Lead Sponsor
- FrieslandCampina Nederland BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Age =65 and =80
• BMI =20 and =32 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
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before day 1 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 unexpected 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 to give up blood donation during the study
• Personnel of NIZO food research and FrieslandCampina, 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 or her health, like laboratory
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to investigate postprandial amino acid kinetics in blood after consumption of concentrated protein products in small volumes providing different (blends of) dairy proteins, with different energy content densities in an older population
- Secondary Outcome Measures
Name Time Method The secondary objectives of the study is to investigate postprandial glucose and insulin kinetics in blood after consumption of concentrated protein products in small volumes providing different (blends of) dairy proteins, with different energy content densities in an older population.