Clinical trial NCT03547362: Real-time Amino Acid Profiling
Official title: Real-time Amino Acid Profiling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Digestion Kinetics
Keywords: Amino acids
Dairy proteins
Postprandial
Older adults
Lead sponsor: NIZO Food Research
Sponsor class: OTHER
Collaborators: name: FrieslandCampina
First posted: 2018-06-06
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Postprandial serum amino acid concentration
timeFrame: 0-300 min after consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Ede
country: Netherlands
facility: NIZO Food Research
state: Gelderland
Study officials:
affiliation: NIZO Food Research
name: Melle van Schaik
role: STUDY_DIRECTOR
References: