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Postprandial Blood Amino Acid Response (PARROT-2)

N

NIZO Food Research

Status

Completed

Conditions

Protein Digestion Kinetics

Treatments

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

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03313791
NIZO175 (Other Identifier)
NL62458.072.17

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

10 participants in 12 patient groups

Whey protein concentrate
Experimental group
Description:
portion size that contains 25 g of protein, oral, single administration
Treatment:
Dietary Supplement: Whey protein concentrate
Yoghurt
Experimental group
Description:
portion size that contains 25 g of protein, oral, single administration
Treatment:
Dietary Supplement: Yoghurt
50%whey-50% casein (Standard)
Experimental group
Description:
portion size that contains 25 g of protein, oral, single administration
Treatment:
Dietary Supplement: 50%whey-50% casein (Standard)
50%whey-50% casein (Alternative)
Experimental group
Description:
portion size that contains 25 g of protein, oral, single administration
Treatment:
Dietary Supplement: 50%whey-50% casein (Alternative)
Micellar Casein Isolate- WPH
Experimental group
Description:
portion size that contains 25 g of protein, oral, single administration
Treatment:
Dietary Supplement: Micellar Casein Isolate- WPH
Micellar Casein Isolate - Na-caseinate
Experimental group
Description:
portion size that contains 25 g of protein, oral, single administration
Treatment:
Dietary Supplement: Micellar Casein Isolate - Na-caseinate
Micellar Casein Isolate
Experimental group
Description:
portion size that contains 25 g of protein, oral, single administration
Treatment:
Dietary Supplement: Micellar Casein Isolate
UHT milk
Experimental group
Description:
portion size that contains 25 g of protein, oral, single administration
Treatment:
Dietary Supplement: UHT milk
Recombined milk
Experimental group
Description:
portion size that contains 25 g of protein, oral, single administration
Treatment:
Dietary Supplement: Recombined milk
Recombined 50% whey milk
Experimental group
Description:
portion size that contains 25 g of protein, oral, single administration
Treatment:
Dietary Supplement: Recombined 50%whey milk
Ca-caseinate
Experimental group
Description:
portion size that contains 25 g of protein, oral, single administration
Treatment:
Dietary Supplement: Ca-caseinate
Milk protein isolate
Experimental group
Description:
portion size that contains 25 g of protein, oral, single administration
Treatment:
Dietary Supplement: Milk protein isolate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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