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Real-time Amino Acid Profiling

Real-time Amino Acid Profiling

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03547362
Acronym
RAP
Enrollment
12
Registered
2018-06-06
Start date
2018-05-30
Completion date
2018-07-05
Last updated
2018-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein Digestion Kinetics

Keywords

Amino acids, Dairy proteins, Postprandial, Older adults

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.

Interventions

DIETARY_SUPPLEMENTCasein

See arm description

DIETARY_SUPPLEMENTDairy protein blend 1

See arm description

DIETARY_SUPPLEMENTWhey protein

See arm description

DIETARY_SUPPLEMENTDairy protein blend 2

See arm description

DIETARY_SUPPLEMENTDairy protein blend 3

See arm description

DIETARY_SUPPLEMENTDairy protein blend 4

See arm description

Sponsors

FrieslandCampina
CollaboratorINDUSTRY
NIZO Food Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postprandial serum amino acid concentration0-300 min after consumptionBlood amino acid concentrations (mmol/L) before and at 13 time points (up till 5 hours) after consumption of the dairy products.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026