Postprandial Blood Amino Acid Response

Study Overview
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Brief Summary
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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.

Official Title
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Postprandial Blood Amino Acid Concentrations After Dairy Consumption

Conditions
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Protein Digestion Kinetics

Intervention / Treatment
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* Dietary Supplement: Whey protein concentrate
* Dietary Supplement: Yoghurt
* Dietary Supplement: 50%whey-50% casein (Standard)
* Dietary Supplement: 50%whey-50% casein (Alternative)
* Dietary Supplement: Micellar Casein Isolate- WPH
* Dietary Supplement: Micellar Casein Isolate - Na-caseinate
* Dietary Supplement: Micellar Casein Isolate
* Dietary Supplement: UHT milk
* Dietary Supplement: Recombined milk
* Dietary Supplement: Recombined 50%whey milk
* Dietary Supplement: Ca-caseinate
* Dietary Supplement: Milk protein isolate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whey protein concentrate<br>portion size that contains 25 g of protein, oral, single administration | Dietary Supplement: Whey protein concentrate<br>* see arm description<br>|
| Experimental: Yoghurt<br>portion size that contains 25 g of protein, oral, single administration | Dietary Supplement: Yoghurt<br>* see arm description<br>|
| Experimental: 50%whey-50% casein (Standard)<br>portion size that contains 25 g of protein, oral, single administration | Dietary Supplement: 50%whey-50% casein (Standard)<br>* see arm description<br>|
| Experimental: 50%whey-50% casein (Alternative)<br>portion size that contains 25 g of protein, oral, single administration | Dietary Supplement: 50%whey-50% casein (Alternative)<br>* see arm description<br>|
| Experimental: Micellar Casein Isolate- WPH<br>portion size that contains 25 g of protein, oral, single administration | Dietary Supplement: Micellar Casein Isolate- WPH<br>* see arm description<br>|
| Experimental: Micellar Casein Isolate - Na-caseinate<br>portion size that contains 25 g of protein, oral, single administration | Dietary Supplement: Micellar Casein Isolate - Na-caseinate<br>* see arm description<br>|
| Experimental: Micellar Casein Isolate<br>portion size that contains 25 g of protein, oral, single administration | Dietary Supplement: Micellar Casein Isolate<br>* see arm description<br>|
| Experimental: UHT milk<br>portion size that contains 25 g of protein, oral, single administration | Dietary Supplement: UHT milk<br>* see arm description<br>|
| Experimental: Recombined milk<br>portion size that contains 25 g of protein, oral, single administration | Dietary Supplement: Recombined milk<br>* see arm description<br>|
| Experimental: Recombined 50% whey milk<br>portion size that contains 25 g of protein, oral, single administration | Dietary Supplement: Recombined 50%whey milk<br>* see arm description<br>|
| Experimental: Ca-caseinate<br>portion size that contains 25 g of protein, oral, single administration | Dietary Supplement: Ca-caseinate<br>* see arm description<br>|
| Experimental: Milk protein isolate<br>portion size that contains 25 g of protein, oral, single administration | Dietary Supplement: Milk protein isolate<br>* see arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iAUC for postprandial individual plasma amino acids |  | Time Frame: 0-300 min after consumption | 
| Cmax for postprandial individual plasma amino acids |  | Time Frame: 0-300 min after consumption |