- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03547362
Real-time Amino Acid Profiling (RAP)
July 10, 2018 updated by: NIZO Food Research
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gelderland
-
Ede, Gelderland, Netherlands, 6718ZB
- NIZO food research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Casein
Single oral administration
|
See arm description
|
Experimental: Dairy protein blend 1
single oral administration
|
See arm description
|
Experimental: Whey protein
Single oral administration
|
See arm description
|
Experimental: Dairy protein blend 2
Single oral administration
|
See arm description
|
Experimental: Dairy protein blend 3
Single oral administration
|
See arm description
|
Experimental: Dairy protein blend 4
Single oral administration
|
See arm description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial serum amino acid concentration
Time Frame: 0-300 min after consumption
|
Blood amino acid concentrations (mmol/L) before and at 13 time points (up till 5 hours) after consumption of the dairy products.
|
0-300 min after consumption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2018
Primary Completion (Actual)
July 5, 2018
Study Completion (Actual)
July 5, 2018
Study Registration Dates
First Submitted
April 20, 2018
First Submitted That Met QC Criteria
May 23, 2018
First Posted (Actual)
June 6, 2018
Study Record Updates
Last Update Posted (Actual)
July 11, 2018
Last Update Submitted That Met QC Criteria
July 10, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL65184.072.18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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