Real-time Amino Acid Profiling

Study Overview
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Brief Summary
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This study was designed to obtain information about the effect of new combinations of dairy proteins, in small servings with high protein concentrations, on postprandial amino acid kinetics in blood in an older population.

Official Title
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Real-time Amino Acid Profiling

Conditions
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Protein Digestion Kinetics

Intervention / Treatment
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* Dietary Supplement: Casein
* Dietary Supplement: Dairy protein blend 1
* Dietary Supplement: Whey protein
* Dietary Supplement: Dairy protein blend 2
* Dietary Supplement: Dairy protein blend 3
* Dietary Supplement: Dairy protein blend 4


Participation Criteria
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Eligibility Criteria
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Inclusion 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 Exclusion Criteria: 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 results and eventual adverse events to and from his general practitioner

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study is designed as a randomized, single-blinded within-subject (cross-over) trial in which a group of 12 subjects receive 6 different dairy products.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Casein<br>Single oral administration | Dietary Supplement: Casein<br>* See arm description<br>|
| Experimental: Dairy protein blend 1<br>single oral administration | Dietary Supplement: Dairy protein blend 1<br>* See arm description<br>|
| Experimental: Whey protein<br>Single oral administration | Dietary Supplement: Whey protein<br>* See arm description<br>|
| Experimental: Dairy protein blend 2<br>Single oral administration | Dietary Supplement: Dairy protein blend 2<br>* See arm description<br>|
| Experimental: Dairy protein blend 3<br>Single oral administration | Dietary Supplement: Dairy protein blend 3<br>* See arm description<br>|
| Experimental: Dairy protein blend 4<br>Single oral administration | Dietary Supplement: Dairy protein blend 4<br>* See arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial serum amino acid concentration | Blood amino acid concentrations (mmol/L) before and at 13 time points (up till 5 hours) after consumption of the dairy products. | 0-300 min after consumption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amino acids, Dairy proteins, Postprandial, Older adults