Postprandial Plasma Amino Acid Concentrations After Dairy Consumption (PARROT)

This study was designed to obtain information about the change in postprandial amino acids in blood over time, after consumption of different dairy products, in an elderly population and how this relates to gastric emptying rate and feelings of satiety.

Study Overview

• Status: Completed
• Conditions: Protein Digestion Kinetics
• Intervention / Treatment: Other: skimmed milk (UHT); Other: skimmed milk (pasteurized); Other: skimmed yoghurt; Other: full-fat milk (UHT); Other: non-homogenized full-fat milk (pasteurized); Other: full-fat cheese (semi-matured); Other: whey protein; Other: micellar casein

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Ede, Netherlands
    • NIZO food research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age over 60y
• BMI 21-30 kg/m2
• Non-smoking
• Healthy as assessed by the NIZO lifestyle and health questionnaire
• 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)

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
• A self-reported allergy or sensitivity to acetaminophen
• Alcohol consumption > 28 units/week and 4/day
• Reported unexplained 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 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 health, like laboratory results and eventual adverse events to and from his general practitioner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: skimmed milk (UHT); portion size that contains 25 g of protein, oral, single administration	Other: skimmed milk (UHT)
ACTIVE_COMPARATOR: skimmed milk (pasteurized); portion size that contains 25 g of protein, oral, single administration	Other: skimmed milk (pasteurized)
ACTIVE_COMPARATOR: skimmed yoghurt; portion size that contains 25 g of protein, oral, single administration	Other: skimmed yoghurt
ACTIVE_COMPARATOR: full-fat milk (UHT); portion size that contains 25 g of protein, oral, single administration	Other: full-fat milk (UHT)
ACTIVE_COMPARATOR: non-homogenized full-fat milk (pasteurized); portion size that contains 25 g of protein, oral, single administration	Other: non-homogenized full-fat milk (pasteurized)
ACTIVE_COMPARATOR: full-fat cheese (semi-matured); portion size that contains 25 g of protein, oral, single administration	Other: full-fat cheese (semi-matured)
ACTIVE_COMPARATOR: whey protein; portion size that contains 25 g of protein, oral, single administration	Other: whey protein
ACTIVE_COMPARATOR: micellar casein; portion size that contains 25 g of protein, oral, single administration	Other: micellar casein

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NIZO Food Research
• Collaborators: FrieslandCampina

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: September 8, 2015
• First Submitted That Met QC Criteria: September 8, 2015
• First Posted (ESTIMATE): September 10, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: NL53912.081.15; METC nr 15/18 (OTHER: Medical Ethical Committee- Wageningen University)