Postprandial Plasma Amino Acid Concentrations After Dairy Consumption
PARROT
2 other identifiers
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2015
CompletedFirst Posted
Study publicly available on registry
September 10, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 12, 2016
January 1, 2016
2 months
September 8, 2015
January 11, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (8)
skimmed milk (UHT)
ACTIVE COMPARATORportion size that contains 25 g of protein, oral, single administration
skimmed milk (pasteurized)
ACTIVE COMPARATORportion size that contains 25 g of protein, oral, single administration
skimmed yoghurt
ACTIVE COMPARATORportion size that contains 25 g of protein, oral, single administration
full-fat milk (UHT)
ACTIVE COMPARATORportion size that contains 25 g of protein, oral, single administration
non-homogenized full-fat milk (pasteurized)
ACTIVE COMPARATORportion size that contains 25 g of protein, oral, single administration
full-fat cheese (semi-matured)
ACTIVE COMPARATORportion size that contains 25 g of protein, oral, single administration
whey protein
ACTIVE COMPARATORportion size that contains 25 g of protein, oral, single administration
micellar casein
ACTIVE COMPARATORportion size that contains 25 g of protein, oral, single administration
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NIZO Food Researchlead
- FrieslandCampinacollaborator
Study Sites (1)
NIZO food research
Ede, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2015
First Posted
September 10, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 12, 2016
Record last verified: 2016-01